Food & Drug Administration (FDA) Approvals

Michael Scally MD

Doctor of Medicine
10+ Year Member
Endo Pharmaceuticals Receives FDA Approval for FORTESTA(TM) (Testosterone) Gel as a Class III Product for Topical Use for Men with Low Testosterone
Endo Pharmaceuticals - Press Release

FORTESTA Gel is the first approved testosterone replacement therapy gel with application to the front and inner thighs

CHADDS FORD, Pa., Dec. 29, 2010 /PRNewswire via COMTEX/ --

Endo Pharmaceuticals (Nasdaq: ENDP) today announced that the U.S. Food and Drug Administration (FDA) has approved FORTESTA Gel for the treatment of low testosterone, or 'Low T,' also known as hypogonadism. Symptoms associated with Low T include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis. Low T is a condition that has an estimated prevalence in nearly 14 million men in the United States, yet only about 1.3 million, (9 percent) are currently being treated. Endo Pharmaceuticals expects to introduce FORTESTA(TM) Gel in the United States in early 2011.

"Declining blood levels of testosterone can occur in men beginning as early as age 40. The symptoms of low testosterone can be non-specific and often associated with other chronic medical problems," said Adrian Dobs, M.D., M.H.S., professor of medicine and oncology, Johns Hopkins University School of Medicine, Division of Endocrinology and Metabolism in Baltimore, Md., and principal investigator of the FORTESTA Gel Phase III clinical trial. "FORTESTA Gel is an important new treatment option for men who are diagnosed with low testosterone."

FORTESTA Gel is a clear, colorless, odorless gel that is gently applied with one finger to the front and inner thighs, and not the upper body. FORTESTA Gel comes in a metered-dose pump that delivers the correct dose per complete depression. Patients using FORTESTA Gel should apply the product as directed. Safety and efficacy of FORTESTA Gel in males less than 18 years old have not been established.

"The approval of FORTESTA(TM) Gel reinforces our commitment to men's health by providing an important new treatment option for millions of men with Low T," said David Holveck, chief executive officer, Endo Pharmaceuticals.

In a 90-day, multicenter, open-label, non-comparative, pivotal Phase III trial involving men with hypogonadism, 78 percent of patients using FORTESTA(TM) Gel had an average serum total testosterone concentration within the normal range at day 90. The most common side effect in this trial was application site reactions.
 
FORTESTA™ (TESTOSTERONE) GEL
http://www.endo.com/FORTESTA.aspx

This product information is intended for U.S. residents only. [See Attached]

FORTESTA™ (testosterone) Gel for topical use CIII is an androgen indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism or hypogonadotrophic hypogonadism. Important limitations of use: Safety and efficacy of FORTESTA Gel in males <18 years old have not been established.
 

Attachments

Endo Pharmaceuticals Receives FDA Approval for FORTESTA(TM) (Testosterone) Gel as a Class III Product for Topical Use for Men with Low Testosterone
Endo Pharmaceuticals - Press Release

FORTESTA Gel is the first approved testosterone replacement therapy gel with application to the front and inner thighs

So, I guess the other three gels on the market don't work when applied to "the front and inner thighs" :confused:
 
New T Gel Fortesta

Don't know if anyone posted this or is familar with it but any feedback would be nice.

http://www.newsmaxhealth.com/health_stories/testosterone_gel_men/2010/12/30/369049.html?s=al&promo_code=B636-1
 
Re: New T Gel Fortesta

Don't know if anyone posted this or is familar with it but any feedback would be nice.

http://www.newsmaxhealth.com/health_stories/testosterone_gel_men/2010/12/30/369049.html?s=al&promo_code=B636-1

Do you need to shave the thighs? Is this a 1% or 2% gel?
 
I had to look, now I cant help myself....:D

WARNING: This writing is going to be the most convoluted attempt at a technical interpretation of data you have ever seen me produce. But if you are hesitant to lend me any credence I will point out one thing first. THiS DATA PROVES EXACTLY WHAT I HAVE BEEN SAYING - THAT SERUM COUNTS MEAN NOTHING OF ACTUAL VOLUMES OF TESTOSTERONE PROCESSED.. And to what, who knows. I am vindicated....

I am not expert or doc either. I AM,,,, ANEC-MAN...................

And their resulting "P" was greater than %5 to possibly achieve the supraphysiological TT levels of 1800-2499 NG/DL?!?!?!??!!!!!!!!!!!!!!!!!!!!!!!!!!!!!! Gee, so whats the P on a normal range.....[:o)] OK, 77%... Still says nothing about actual metatabolism. This speak volumes about my hypothesis of NUMBER COUNTS PROCESSES going on as incalculable... 10-70mgs a day... WTF... Either a shitload is getting wiped off ineffected, or a shitload is being processed unaccounted... I think the truth is somewhere in there.....

Bear with me as I jump around this read with my BAZOOKA>.. But you could really just blindfold yourself and throw darts to pick this one...

I pursued the company info and determined this is the group to trademark the incorporation of oxycodone as Percocet?!?!!? and other forms of transdermally applied oxycodone.....

I was impressed in many ways. MOSTLY SHOCKED AT THE WHOLE THING...

FIRST. I have to say that the pharmacological prescribing info was written like a steroid abusing idiot had a wet dream and wrote it down upon waking........:eek: I was barking the other day about the fact that I find it so interesting the limited amount of information provided about testosterone metabism that is available from companies like UpJohn, who produce testosterone Depot.... So finally I see a company has provided further infor. Like elimination. I found it interesting that they described the path as 90% kidney / urine which explains the stong smell I used to get when pissing on withing 24-48 hours of dosing TRT heavy side. STILL They failed to identify unmetabolized Testosterone exit pathways, and what proportions, and what they come out as.... I do notice that they address DEPOT testosteroe here... HOW THE FUCK DOES THAT APPLY AT ALL!?!?!?! I am starting to think esterfied testosterone distributes on a MASSIVE SCALE throughout the body into fat. Because for this company to actually denote the urine metabolism derivative, it proves all that much more, that it is more likely to process immediately with no ester attached to it, and makes me wonder IF ANY AT ALL CAN ESCAPE WITHOUT BEING FIRST METABOLIZED...!?!?! For them to state that here would indicate that a lot of users report the smell of the excretion. So hen does this help to conclude that esterfied testosterone gets deposited throughout the body into fat!?!? I wonder.

So lets take a closet look at the prescribing info here.
1. Note the application with the pump apparatus. I find it amusing that they list dosing protocol based on serum feedbacks as a "zero in approach". The whole notion of associating a pump with specifics of implied accuracy if so fucked... At least creams are accurately dosed at the application point.... However, I am guessing they have some delivery method to get through the skin that is quicker and more conclusive (first thoughts to change)...

2. LETS BACK UP A STEP... 1 INDICATIONS AND USAGE FORTESTA is an androgen indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) – testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol, heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH)) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired) – idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low serum testosterone concentrations but have gonadotropins in the normal or low range.

a.) Look at that English grammar, syntax, and use of for a conglomeration of words that looks like a retard wrote it.!!! Confusing, run-on, vaguely borderline incorrect. Why cant they just say PRIMARY, the nuts dont work due to injury, so the brain puts out high levels of LH/FSH attempting to kick em up not knowing they are hurt... Or secondly, Secondary, the brain is injured and not putting out enough LH...? (Except of course better put). You get the point. Its like the guy that wrote it did not even really understand the concepts. THIS MAY BE A FIRST IN HISTORY TO MAKE THIS ATTEMPT.... Amazing... Further to see it described and knowing what the intention was, almost demonstrates an attempt at discrediting the entrie validity of Testosterone as a drug therapy.... Just unbelievable... They get specific with potential causes, and then act like invitees to "fools night out".... Is this a waking subvert or what....

And what about the dosing reginmen?!?!? 40mgs a day. WTF?? I am now thinking their delivery is SHIT. Note how they openly discuss not to handle children and women with spray areas. They are the first to acknowledge this, but now I know why!!! Sweet Hesus... With effective rates that low.. OR ARE THEY? Again we are taking serum counts and HAVE NO IDEA HOW MUCH IS USED.

FURTHER, as they discuss elimination through urine as an acid, they stil can't qauntify how this relates to volume processed, only proportions could be attained this way... THey give data I dont quite understand, and dont bother to elaborate. So 6% is fecal unconjugated, but does metabolism yield exponetial returns on eliminated molecules perhaps, and in which directions?

Jumping Forward, look at the chart describing the steady state concentrations on day 90. DO ALL CHARTS LOOK LIKE THIS BECAUSE THIS IS THE FIRST TIME I HAVE EVER REALLY TRYIED TO DECIPHER ONE... So on Day 90, (23=N) of the total (149(N)) patients were dosing at 70 MGS A DAY!!.. AND of that 23 patients, the had an AVERAGE Blood Count of 415 ng/dl with a Maximum blood count of 724ng/dl withing the 24 period of the last day, and prior to the dose.... Look at the standard deviations of 136 & 313 for that column.. Thats about 33 - 45% in relation to Ng/dl measured. Now see how the standard deviations (How close other measurements were) of the lower daily dosings and note they are all higher. It makes sense and it doesn't.. For the middle dosing range to achieve the highest TT values AND highest deviations at the same time EVEN (as compared to 70mg group) could only state that the 70 mg/day group are fucking idiots.. OR DOES IT SAY NOTHING AS WE STILL HAVE NO IDEA WHO BURNED HOW MUCH OF WHAT>...:D And perhaps they burn through a lot more faster and their blood levels stay lower because of.. WHO FUCKING KNOWS BECAUSE THERE HAVE BEEN NO OTHER MEASURES OF THE IMPORTANT FACTORS THAT ARE INCALCULABLE... THe chart does speak volumes in the fact that all dosing regiments had about the same average & Max blood concentrations throughout the day, yet some put on more and some put on less.... Further the deviation remaining the same thoughout different number of folks dosing at the whole specturm of MGs says alot when you consider the previous sentence. IF you look at this chart from my perspective of DEMAND BASED Production and usage, you can see that the VARIANCE IN EFFECT is not related to the drug, BUT THE INDIVIDUAL.... So how does a 20mg/day patient have the same measured Serim TT counts as the 70 mgs/day patient. Have I said it yet,,,, DEMAND BASED USAGE. THIS SAYS EXACTLY THAT MOUNTAINS OF TESTOSTERONE ARE PROCESSED WITH NO UNIT COUNTER APPLYING. How in the hell could someone putting on 20mgs/day have the same blood counts as someone putting on 70mgs/day.!?!? Well, they cant be all that stupid as to not be able to hit the target with a spay pump.. THEY ARE USING COMPLETELY DIFFERENT AMOUNTS. AND VARYING BY THE BUSHELL....... THis data can only prove that SERUM COUNT MEANS JACK SHIT.....:) And acutally, I would have liked to see how much remained on the skin at the end of 24 hours in the different dosing groups, thus, can the body only take what it wants at that level too....

NOTE SHBG Changed in none. Of course at it is a fine tune tweek already stressed by the current situation prior to application. THEY WERE PROBABLE ALL 20-40 if primary, or 10-12 if secondary. Secondary being the widely molested term today where the "Low-T" male falls. NOTICE THEY DID NOT MENTION HIM IN THEIR LIST OF CAUSES....:eek:

Notice they only credit 40% of TT to be regulated by SHBG, and 48% by Albumin. Is that correct.?? I think I need to learn more about loosely bound. Could that simply be a stage where the SHBG is partially released (or the reverse- prior to that), and one state is more in flux and EITHER READY TO GO OR GET PISSED OUT. Kinda the "on-deck" portion of bound TT???? I wonder...

So a question comming to mind is: IF secondary hypogonadism is the brains failure to send signal, and primary is the failure of the testicles to produce. Then dont we have a chicken or egg quandry in many cases. How do you determine if the brain did not cause the testicles to shut down and shrivel up when they are so vague about effective LH numbers not to mention there appear to be an effective curve with regard to the rate of return at as the number decrease (returns remain adequate till below 1, moreso IMO). Plus I am thinking differnt testicles produce different volumes per unit of LH depending on the model of testicle [:o)]

Fuckit I am done for now. This was definitely groundbreaking publication as far as I know. I have not seen anything like it published for a SynT application. Am I in the dark ages??
 
Last edited:
Theres already two gels on the market what makes this so special? just the fact that you could apply it to your inner thighs?
 
There is no difference in the drug. The time for delivery looks the same too. Thought at first it was in a spray/mist type application in order to provide a mess free application, but it only appears to be gel except in a multidose "lotion" type container, rather than a tube you squeeze. So perhaps this is supposed to make the dosing more mindlessly accurate and prevent "rubbin in a little extra"... It would also appear marketed as a first in being adjustible in 10mg measurable increments, rather than a 50mg dose of 1% cream. SO this may be the point.

My above analysis of the appearing heavy dosing was incorrect due to my lack on knowledge about creams, as there appears to be a poor return in terms of absorbtion efficiency. So larger doses appear necessary to deliver this way. That still changes nothing of my above general premise with relation to actual metabolism rates of TT.

If you take a tube of Tesim 1% cream, it states there is 5 grams total in a sample tube containing a total 50mgs testosterone. If you do the math then you get 1% of 5grams is 50mgs total. So the question is what is the total size of the load to rub in. They dont really say (I dont think) in the prescribing info, however considering on might rub on as many as 7 doses, or 70mgs, the compositions are probably comparable.

The key here to this product I also suspect is that they have a patented delivery system. Meaning the chemical used to deliver it through the skin. They may feel that it will work more effectively, or steadily with time. I cant help but think that with the emphasis they put on skin reaction. IF YOU NOTE.... I dont think any of the manufactures go to the detail to explain the chemicals used to delivery the testosterone through the skin.. So they may feel they have a niche here. Who knows. Either way, they cant prove it due to the fact that the measurement standards dont account for actual amounts absorbed, and further, successfully metabolized to final derivatives (androgens & Estrogens)...

Regarding the inner thighs. First, this is a place of low body fat percentage relatively speaking in most, which is also CENTRAL and not readily available to contact others or other objects to wipe it off accidentally. Further, the natural bon fire created between the thighs of many patients suffering from low T would provide a natural environement to KEEP ON RUBBING IN THROUGHOUT THE DAY[:o)]. Come to think of it, they should really specifiy the testing with parameters for guys who's thighs rub, and whether or not the wear clothing with big inseams!! Seriously.. But further its is tough skin area in comparison to the scrotum. The fact that they tell you not to apply to the scrotum further tells me the ingredients used to deliver through the skin are more active. It sounds like if you rub this one on your nutz, you will be running for the shower as it may make an pubescent aftershave experience:eek: look like amateur night out....:eek: SO I am guessing they are proud of their delivery system efficiency..

Theres already two gels on the market what makes this so special? just the fact that you could apply it to your inner thighs?
 
The most common side effect in this trial was application site reactions.

The trials are usually just long enough to verify the skin issues that can come along with gels while they feel no responsibility at all to REMIND users that your testicles may shrink and your fertility will be gone. Interesting set of priorities there, huh?

Who gives a rat's ass about a little dermatitis when your Boys vanish and you can no longer become a father?
 
Last edited by a moderator:
Gimme a break and think about it. I havent read the studies but knowing a little about this
: guess we are talking about replacing ethanol as the carrier. TESTICULAR ATROPHY is a given. Apparently everyone knows this but you. If you are pissed off in general and looking for something to take it out on, do as I do: find some dumbass. Dont take it out on the ones having a better grasp of the situation and who are trying to fix the fuckin problem.

The trials are usually just long enough to verify the skin issues that can come along with gels while they feel no responsibility at all to REMIND users that your testicles may shrink and your fertility will be gone. Interesting set of priorities there, huh?

Who gives a rat's ass about a little dermatitis when your Boys vanish and you can no longer become a father?
 
Gimme a break and think about it. I havent read the studies but knowing a little about this
: guess we are talking about replacing ethanol as the carrier. TESTICULAR ATROPHY is a given. Apparently everyone knows this but you. If you are pissed off in general and looking for something to take it out on, do as I do: find some dumbass. Dont take it out on the ones having a better grasp of the situation and who are trying to fix the fuckin problem.

I do know all about it, zkt. That's why I refused to go on Testim when my doctor (who DID NOT know) prescribed it. He also had never heard of Clomid or HCG for TRT, just like a disturbingly high number of endocrinologists have not so my doctor is far, far from being alone in this. And it certainly does not help matters any when the pharamaceutical companies deliberately neglect to clearly state the most notable sides related to using exogenous T. Yes, it's a given, but you have to know it's a given and it isnt too much to expect the doctor to know what the sides will be and give you a heads up. And if he doesnt know or is too busy to tell you, it should at least appear in the drug info label you get with your script. Now, gimme a break, ok?
 
Endo gets green light for new testosterone gel

Maybe this is old news but here it is:

The FDA is giving a green light to a new testosterone gel developed by Endo Pharmaceuticals ($ENDP [1]) and ProStrakan. Shares of Endo were buoyed by the news, Reuters notes.

Fortesta was studied as a treatment for hypogonadism, or low testosterone in men. Once it hits the market, the treatment will be applied along the inner thighs of patients to help avoid any accidental smearing on children or women, who could suffer some unpleasant side effects.

The approval for Fortesta follows close on the heels of another approval for Axiron, a testosterone therapy developed by Eli Lilly and Acrux. AndroGel and Testim, which is expected to earn $633 million this year, are already on the market. Those two therapies contain 1 percent of the active ingredient, according to Reuters, while Fortesta will have a 2 percent concentration.

"Declining blood levels of testosterone can occur in men beginning as early as age 40. The symptoms of low testosterone can be non-specific and often associated with other chronic medical problems," said Adrian Dobs, M.D., M.H.S., professor of medicine and oncology, Johns Hopkins University School of Medicine. "Fortesta Gel is an important new treatment option for men who are diagnosed with low testosterone."

Regulators have been keenly sensitive to the potential safety issues involved. If it comes in contact with children, the treatments could trigger premature physical development, including enlarged sexual organs.

http://www.fiercebiotech.com/story/endo-gets-green-light-new-testosterone-gel/2010-12-30
 
Last edited by a moderator:
FDA approves Clinical Data Inc's antidepressant
FDA approves Clinical Data Inc's antidepressant | Reuters

NEW YORK, Jan 21 (Reuters) - U.S. health regulators on Friday approved Clinical Data Inc's (CLDA.O) - Clinical Data Online - antidepressant vilazodone under the brand name Viibyrd, a potential multibillion-dollar seller that may not interfere with sexual desire as seen with some rival drugs.

The Food and Drug Administration approved Viibyrd at doses of 10 milligrams, 20 mg, and 40 mg for major depressive disorder, or major depression. Clinical Data shares rose nearly 15 percent in extended trading.

Like other antidepressants, Viibyrd will carry a boxed warning and a patient medication guide describing the increased risk of suicidal thinking and behavior in children, adolescents, and young adults ages 18 to 24 during initial treatment.

The warning also says data did not show the increased risk in adults older than 24 and that patients ages 65 and older who take antidepressants have a decreased risk of suicidal thinking and behavior.

Clinical Data believes its drug's dual mechanism of action and side effect profile will differentiate it from a crowded field.

In clinical trials, vilazodone use did not cause significant weight gain or the negative impact on sexual desire or function seen with many other antidepressants that lead many patients to abandon their medicine.


"We're going to be extremely well positioned in a category where under 50 percent of individuals get satisfaction on their first line therapy," Clinical Data Chief Executive Drew Fromkin told Reuters in an interview last year.

"I absolutely believe that this drug can be north of a $1 billion drug," Fromkin said.

The company is expected to seek additional approvals for other psychiatric conditions, such as anxiety disorders.

Some analysts believe that with additional approvals Viibyrd could eventually garner annual sales in excess of $2 billion.

"Major depressive disorder is disabling and prevents a person from functioning normally," Thomas Laughren, the FDA's, director of the Division of Psychiatry Products, said in a statement.

"Medications affect everyone differently, so it is important to have a variety of treatment options available to patients who suffer from depression," Laughren said.

Clinical Data owns full rights to the drug with Germany's Merck KGaA (MRCG.DE) getting some royalties on sales.
 

Attachments

Last edited:
Federal Research Center Will Help Develop Medicines
http://www.nytimes.com/2011/01/23/health/policy/23drug.html

By GARDINER HARRIS
Published: January 22, 2011

The Obama administration has become so concerned about the slowing pace of new drugs coming out of the pharmaceutical industry that officials have decided to start a billion-dollar government drug development center to help create medicines.

The new effort comes as many large drug makers, unable to find enough new drugs, are paring back research. Promising discoveries in illnesses like depression and Parkinson’s that once would have led to clinical trials are instead going unexplored because companies have neither the will nor the resources to undertake the effort.

The initial financing of the government’s new drug center is relatively small compared with the $45.8 billion that the industry estimates it invested in research in 2009. The cost of bringing a single drug to market can exceed $1 billion, according to some estimates, and drug companies have typically spent twice as much on marketing as on research, a business model that is increasingly suspect.

The National Institutes of Health has traditionally focused on basic research, such as describing the structure of proteins, leaving industry to create drugs using those compounds. But the drug industry’s research productivity has been declining for 15 years, “and it certainly doesn’t show any signs of turning upward,” said Dr. Francis S. Collins, director of the institutes.

The job of the new center, to be called the National Center for Advancing Translational Sciences, is akin to that of a home seller who spruces up properties to attract buyers in a down market. In this case the center will do as much research as it needs to do so that it can attract drug company investment.

That means that in some cases, the center will use one of the institutes’ four new robotic screeners to find chemicals that affect enzymes and might lead to the development of a drug or a cure. In other cases, the center may need to not only discover the right chemicals but also perform animal tests to ensure that they are safe and even start human trials to see if they work. All of that has traditionally been done by drug companies, not the government.

“None of this is intended to be competitive with the private sector,” Dr. Collins said. “The hope would be that any project that reaches the point of commercial appeal would be moved out of the academic support line and into the private sector.”

Whether the government can succeed where private industry has failed is uncertain, officials acknowledge, but they say doing nothing is not an option. The health and human services secretary,Kathleen Sebelius, sent a letter to Congress on Jan. 14 outlining the plan to open the new drug center by October — an unusually rapid turnaround for an idea first released with little fanfare in December.

Creating the center is a signature effort of Dr. Collins, who once directed the agency’s Human Genome Project. Dr. Collins has been predicting for years that gene sequencing will lead to a vast array of new treatments, but years of effort and tens of billions of dollars in financing by drug makers in gene-related research has largely been a bust.

As a result, industry has become far less willing to follow the latest genetic advances with expensive clinical trials. Rather than wait longer, Dr. Collins has decided that the government can start the work itself.

“I am a little frustrated to see how many of the discoveries that do look as though they have therapeutic implications are waiting for the pharmaceutical industry to follow through with them,” he said.

Dr. Collins’s ability to conceive and create such a center in a few short months would have been impossible for most of his predecessors, who had nice offices but little power. But Congress in recent years has invested real budgetary and administrative authority in the director’s office, and Dr. Collins is the first to fully use these new powers.

Under the plan, more than $700 million in research projects already under way at various institutes and centers would be brought together at the new center. But officials hope that the prospect of finding new drugs will lure Congress into increasing the center’s financing well beyond $1 billion.

Hopes of new money may be optimistic. Republicans in the House have promised to cut the kind of discretionary domestic spending that supports the health institutes, and officials are already bracing for significant cuts this year. But Dr. Collins has hinted that he is willing to cannibalize other parts of the health institutes to bring more resources to the new center.

“There are some people that would say this is not the time to do something bold and ambitious because the budget is so tight,” he said. “But we would be irresponsible not to take advantage of scientific opportunity, even if it means tightening in other places.”

For the plan to go into effect by October, the administration must by law get rid of one of the 27 centers and institutes already in existence at the N.I.H. — something that has never been done before. So the administration plans to downgrade the National Center for Research Resources, in part by giving some of its functions to the new drug center.

Researchers and staff members connected to the research resources center have inundated a complaint blog about the coming change. Mark O. Lively, a professor of biochemistry at Wake Forest University and a member of an advisory council to the research resources center, said that he could not understand why the administration was moving so quickly with its plans.

“And the N.I.H. is not likely to be very good at drug discovery, so why are they doing this?” Dr. Lively asked.

But Dr. Garret A. FitzGerald, a professor of medicine and pharmacology at the University of Pennsylvania, said the new center could inspire universities to train a new generation of investigators who could straddle the divide between academia and industry.

“It could be a really good idea,” he said.

Both the need for and the risks of this strategy are clear in mental health. There have been only two major drug discoveries in the field in the past century; lithium for the treatment of bipolar disorder in 1949 and Thorazine for the treatment of psychosis in 1950.

Both discoveries were utter strokes of luck, and almost every major psychiatric drug introduced since has resulted from small changes to Thorazine. Scientists still do not know why any of these drugs actually work, and hundreds of genes have been shown to play roles in mental illness — far too many for focused efforts. So many drug makers have dropped out of the field.

For Dr. Thomas R. Insel, director of the National Institute of Mental Health, the drug industry’s departure from this vital research area shows that the government must do something, although he acknowledges the risk.

“Would we be foolish — we being an agency that has never developed drugs and actually doesn’t know how to do therapeutics that well — to get into this space?” Dr. Insel asked.

But Dr. William Potter, who was once a top researcher at the mental health institute and retired last year as the vice president of translational neuroscience at the giant drug maker Merck, said that far more basic research needed to be done on the causes of mental illness before anyone — industry or government — could successfully create breakthrough drugs.

“We still don’t even understand how lithium works,” Dr. Potter said. “So how do people think we can find drugs systematically for mental illness?”
 
Abbott Receives U.S. FDA Approval for AndroGel® 1.62% to Treat Men with Low Testosterone
New, Low-Volume Formulation to Help Restore Low Testosterone Levels in Men
Abbott Receives U.S. FDA Approval for AndroGel® 1.62% to Treat Men with Low Testosterone: April 29, 2011

ABBOTT PARK, Ill., April 29, 2011 /PRNewswire/ -- Abbott (NYSE:ABT - News) announced today that the U.S. Food and Drug Administration (FDA) has approved AndroGel® (testosterone gel) 1.62%, a clear, odorless, gel formulation shown to restore testosterone levels in hypogonadal men with half the volume of gel at the starting dose compared to AndroGel 1%. At the starting dose, the new AndroGel 1.62% contains 40.5 mg of testosterone in two pump presses, whereas AndroGel 1% contains 50 mg of testosterone in four pump presses. Dosage and administration for AndroGel 1.62% differs from AndroGel 1% and the two are not interchangeable. Both AndroGel 1.62% and AndroGel 1% are prescription medications used to treat adult males with low or no testosterone, also known as hypogonadism.
 
Last edited:
Abbott Receives U.S. FDA Approval For AndroGel® 1.62%

http://www.medicalnewstoday.com/articles/223799.php

Abbott (NYSE: ABT) announced that the U.S. Food and Drug Administration (FDA) has approved AndroGel® (testosterone gel) 1.62%, a clear, odorless, gel formulation shown to restore testosterone levels in hypogonadal men with half the volume of gel at the starting dose compared to AndroGel 1%. At the starting dose, the new AndroGel 1.62% contains 40.5 mg of testosterone in two pump presses, whereas AndroGel 1% contains 50 mg of testosterone in four pump presses. Dosage and administration for AndroGel 1.62% differs from AndroGel 1% and the two are not interchangeable.

The FDA approval of AndroGel 1.62% was based on a two-phase, 364-day controlled clinical study. The first phase was a multi-center, randomized, double-blind, parallel-group, placebo-controlled study of 274 hypogonadal men. All eligible patients received AndroGel 1.62% (dosed at 20.25 mg, 40.5 mg, 60.75 mg, or 81 mg) or placebo once daily and returned to the clinic for periodic testosterone assessments. The primary endpoint was the percent of patients achieving normal average testosterone levels (300-1,000 ng/dL) on day 112. A total of 191 patients agreed to continue in an open-label, active treatment maintenance period of the study for an additional 182 days.

The study found the majority of hypogonadal men (82 percent) who took AndroGel 1.62% achieved a normal average testosterone level at day 112. For those taking AndroGel 1.62%, the average testosterone level achieved at day 112 was 561 ng/dL.

During the open-label active treatment maintenance period, 78 percent of men who received AndroGel 1.62% for one year had an average testosterone level in the normal range at day 364. The most common side effects reported with use of AndroGel 1.62% are increased prostate specific antigen (a test used to screen for prostate cancer), mood swings, high blood pressure, increased red blood cell count, and skin irritation where AndroGel 1.62% is applied.
 
Abbott Receives U.S. FDA Approval for AndroGel® 1.62% to Treat Men with Low Testosterone
Not to be cynical or nothing, but I'm thinking that means 1% testosterone gel must be fixing to go generic. ... Aw fuck it, I am being cynical, but I'm guessin' I'm also probably right.
 
Back
Top