Repros Therapeutics Inc. (Public, NASDAQ:RPRX)

Discussion in 'Men's Economics' started by Michael Scally MD, Aug 13, 2011.

  1. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    [IMO, RPRX is a SCAM. I highly suggest staying away from this company as an investment. As their own biography states, they have been a Public Company since 1987 (24+ years) and have absolutely NOTHING to show for it except one failure after another. For men, Androxal [Enclomiphene] is the attractive treatment, but it will NEVER be approved for the indication studied. As far as Proellex, this drug is DOA.]


    Repros Therapeutics Inc. (Public, NASDAQ:RPRX) Repros Therapeutics
    IR: Repros Therapeutics

    GF: Repros Therapeutics Inc.: NASDAQ:RPRX quotes & news - Google Finance
    YF: RPRX: Summary for Repros Therapeutics Inc.- Yahoo! Finance
    SA: Repros Therapeutics Inc. (RPRX) Stock - Seeking Alpha

    SEC: EDGAR Search Results

    2011 10-2Q: http://www.sec.gov/Archives/edgar/data/897075/000114420411044757/v229838_10q.htm
    2010 10-K: Unassociated Document


    Repros Therapeutics Inc. was organized on August 20, 1987. We are a development stage biopharmaceutical company focused on the development of oral small molecule drugs for major unmet medical needs in male and female health.

    Our current product pipeline (with the respective status of development) consists of the following:

    Androxal® (male reproductive health):

    Completed Phase 2b proof-of-concept trial in men being treated for low testosterone levels who want to improve or maintain their fertility and/or sperm number and function; and

    Our Investigational New Drug Application, or IND, for the study of oral Androxal® in the treatment of hypogonadal men with type 2 diabetes was accepted by the FDA and, thus, we may initiate a Phase 2a trial.

    Our primary product candidate, Androxal®, is a single isomer of clomiphene citrate and is an orally active proprietary small molecule compound being developed for men of reproductive age with low testosterone levels who want to improve or maintain their fertility and/or sperm function while being treated for low testosterone. Additionally, Repros plans to develop Androxal® for men with adult-onset idiopathic hypogonadotrophic hypogonadism, or AIHH, with concomitant plasma glucose and lipid elevations, all of which are components of Metabolic Syndrome.

    We believe Androxal® may have advantages over current therapies for the treatment of low testosterone due to secondary hypogonadism because it is designed as an oral therapy that acts centrally to restore testicular function and hence normal testosterone in the body, as compared to currently approved products that simply replace diminished testosterone either through injections, nasal spray or the application of a gel or cream containing testosterone over a percentage of body area.

    Proellex® (female reproductive health):

    On June 10, 2010, the Food and Drug Administration (FDA) notified Repros that the full clinical hold for the Company's Proellex Investigational New drug Applications (INDs) was lifted to partial clinical hold status. The Company will be allowed to run a single study under the new partial clinical hold status. The new low dose study is designed to explore both safety and signals of efficacy in an escalating dose fashion.
     
    Last edited: Aug 13, 2011
  2. Michael Scally MD

    Michael Scally MD Doctor of Medicine

  3. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    It should be noted the COI of the corresponding author. RD Wiehle is a RPRX employee (one of about 6) who undoubtedly contributed only to the writing of the article, no more. Further, the very selective data used for the report. In fact, this attempt at selective use of data led to RPRX problems in their current clinical site studies. RPRX asked but was denied by the FDA to exclude data on sperm counts, which were consistent with published data on topical testosterone. RPRX selected use of data on sperm counts is important since this is the endpoint needed for FDA Approval, NOT serum testosterone.

    Kaminetsky J, Werner M, Fontenot G, Wiehle RD. Oral Enclomiphene Citrate Stimulates the Endogenous Production of Testosterone and Sperm Counts in Men with Low Testosterone: Comparison with Testosterone Gel. The Journal of Sexual Medicine. Oral Enclomiphene Citrate Stimulates the Endogenous Production of Testosterone and Sperm Counts in Men with Low Testosterone: Comparison with Testosterone Gel - Kaminetsky - 2013 - The Journal of Sexual Medicine - Wiley Online Library

    Introduction - clomiphene citrate is employed off-label in men who have low testosterone and for the restoration of sperm counts in men who have used exogenous testosterone. Clomiphene is a mixture of two diastereoisomers: zuclomiphene and enclomiphene. We evaluated enclomiphene citrate in men with secondary hypogonadism.

    Aim - Our aim was to compare oral enclomiphene citrate as an alternative to topical testosterone.

    Main Outcome Measures - Blood levels of total testosterone (TT), estradiol, follicle-stimulating hormone (FSH), luteinizing hormone (LH), sex hormone binding globulin, thyroid stimulation hormone, prolactin, and insulin-like growth factor 1 igf-1 were measured at certain times after treatment with each agent. Sperm parameters were determined at the same visits. Free testosterone (FT) was calculated.

    Methods - This was a proof-of-principle, randomized, open-label, fixed dose, active-control, two-center phase IIB study in 12 men with secondary hypogonadism treated previously with topical testosterone.

    Results - After discontinuation of topical testosterone, morning TT values averaged 165?±?66?pg/dL. After 3 months, there was a significant rise in men receiving enclomiphene citrate and gel that was sustained for 3 months. At 6 months, TT levels were 545?±?268 and 525?±?256?pg/dL for groups receiving the gel and enclomiphene citrate, respectively. Only men in the enclomiphene citrate group demonstrated increased LH and FSH. TT decreased one month posttreatment to pretreatment values. Enclomiphene citrate elevated sperm counts in seven out of seven men at 3 months and six out of six men at 6 months with sperm concentrations in the 75–334?×?106/mL range. The gel was ineffective in raising sperm counts above 20?×?106/mL for all five men at 3 months and raised counts in only two or five men at 6 months. At follow-up, only enclomiphene citrate treatment was associated with elevated sperm counts.

    Conclusions - Enclomiphene citrate increased testosterone and sperm counts. Concomitant changes in LH and FSH suggest normalization of endogenous testosterone production and restoration of sperm counts through the hypothalamic–pituitary–testicular axis.


    Note: Corresponding Author: Ronald D. Wiehle, PhD, Repros Therapeutics, 2408 Timberloch Place, B-7, The Woodlands, TX 77380, USA. Tel: 281-719-3406; Fax: 281-719-3446; E-mail:
    Code:
    rwiehle@reprosrx.com
     
  4. Michael Scally MD

    Michael Scally MD Doctor of Medicine

  5. Michael Scally MD

    Michael Scally MD Doctor of Medicine

  6. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Evaluation Of Enclomiphene And testosterone Gel On Testosterone, Pituitary Hormones And Sperm Function [Abstract: LBA8]
    http://www.aua2013.org/abstracts/archive/printabstracts.cfm?id=98768

    Introduction and Objectives - Enclomiphene, the trans diastereoisomer of clomifene, is a selective oestrogen receptor modulator (SERM) in the pituitary. Blocking the negative oestrogenic feedback results in increased luteinising hormone (LH) levels which then stimulate production of endogenous T. Exogenous T has been shown to reduce spermatogenesis which could be counterproductive in men wishing to preserve fertility. This study compares the impact of enclomiphene with one T gel on certain aspects of endocrine function and spermatogenesis.

    Methods - A double-blind, placebo and active control study of two doses of enclomiphene (12.5 and 25 mg) with open-label on-demand T gel in 120 patients with secondary hypogonadism over a 3-month period. Men were 21-65 years and had not received exogenous T within the previous 6 months.

    Results - All three active groups exhibited statistically significant increases (ng/dl) from baseline in T compared to placebo (Enclomiphene 12.5 mg 217-472; 25 mg 210 406: T gel 210-463: Placebo 214-199). Enclomiphene at both doses increased LH and follicle stimulating hormone (FSH) levels (mIU/ml) beyond baseline and placebo whereas T gel resulted in a >50% reduction in both pituitary hormones (LH Enclomiphene 12.5 mg 4.4-8.9; 25 mg 5.3-11.7: T gel 3.9-1.4: Placebo 3.9-3.7: FSH Enclomiphene 12.5 mg 6.4-11.5; 25 mg 9.4-14.1: T gel 6.0-2.9: Placebo 6.1-5.4). At baseline, the majority of men in all groups exhibited sperm concentrations above the World Health Organization (WHO) limit of normal (15 million sperm per ml of semen). This was maintained in the enclomiphene groups and the placebo group. However, in 13 out of 23 men in the T gel group the sperm concentration dropped below normal.

    Conclusions - Enclomiphene acts at the level of the pituitary as a selective oestrogen receptor modulator to block the negative feedback of oestrogen on the pituitary hormones (LH and FSH). The present study shows that restoration of LH (secondary hypogonadal males having low levels) provides rapid and effective normalisation of T levels with no excursion into the supra-normal range. In addition, preservation of FSH levels in enclomiphene-treated patients ensures that there is no negative impact on sperm function. In contrast, the suppression of sperm function in the T gel group is likely to be a consequence of the observed reduction in FSH. Overall, this study shows that enclomiphene may provide effective therapy in men with secondary hypogonadism, particularly in those wishing to preserve fertility.
     
  7. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Repros Patent Problems Began When Harry Met Joe
    Repros Patent Problems Began When Harry Met Joe - TheStreet

    By Adam Feuerstein - 05/09/13 - 8:00 AM EDT

    Tickers in this article: RPRX

    THE WOODLANDS, Tex. (TheStreet) -- Investors who have read through Repros Therapeutics' regulatory filings know about the unresolved and worrisome patent conflict involving the company's testosterone-boosting pill Androxal. Less known but more interesting are the events behind this patent fight, including allegations that Repros' CEO stole the idea for Androxal from a New York fertility doctor.

    Call the story, "When Harry Met Joe." Except there's no fake orgasm over pastrami sandwiches at Katz's.

    Harry is Dr. Harry Fisch, a New York urologist and fertility specialist. For male patients with low testosterone, particularly those who still want to have kids, Fisch has long prescribed clomiphene, a decades-old hormone treatment normally used to boost fertility in women. In men, clomiphene raises testosterone but also preserves sperm count.

    In 2001, Fisch filed, and was granted, a U.S. patent covering the use of clomiphene to treat androgen testosterone deficiency in men.

    Joe is, of course, Joe Podolski, the CEO of Repros. Back in 2001, Repros, then known as Zonagen, had run into trouble following the failure of an erectile dysfunction drug. With his largest shareholders considering a liquidation of the company, Podolski went in search of a new drug development project that might persuade investors to keep the company afloat.

    At the same time, Fisch was looking for a company to develop and commercialize the idea of using clomiphene to treat men with "low T" based on his recently awarded U.S. patent. He knew Podolski and was aware of Zonagen's problems, so Fisch called Podolski and proposed a meeting in New York City to discuss a possible business idea. Before delving into the details, Fisch asked Podolski to sign a confidentiality agreement. Podolski agreed, signed the confidentiality agreement and traveled from his home in Texas to New York City to meet Fisch.

    Fisch and Podolski met in New York, with Fisch sharing his clomiphene "low T" patent with Podolski and explaining his desire to partner with someone to turn the idea into a business.

    In separate interviews, neither Podolski nor Fisch dispute the version of events up to this point in 2001. In particular, Podolski admits to signing Fisch's confidentiality agreement and gaining access to Fisch's patent. But here's where their stories diverge and the conflict begins.

    According to Fisch, the meeting with Podolski didn't really go anywhere. "Joe told me he wasn't interested in the program," says Fisch. The two men parted ways.

    "I thought more about starting a company to commercialize my concept, but I gave up. I'm not a biopharma expert and didn't think I was qualified to be a biotech CEO. Plus, I had a full-time job already," says Fisch.

    Podolski remembers the meeting with Fisch differently. He liked the idea of using an oral drug like clomiphene to raise testosterone levels in men without reducing sperm counts, but Fisch's patent was weak, he says.

    "I did a quick literature search and literally found 30 or 40 published pieces of prior art which made Harry's clomiphene patent un-enforceable... I told Harry his idea was not patentable," Podolski says. "But if you could isolate an isomer of clomiphene, you might have a better treatment. That would be interesting."

    And that's what Podolksi, working with some consultants, set out to do. The result was Androxal, which is an isomer of clomiphene. The two drugs have the same molecular makeup but Androxal's chemical structure was changed slightly to improve its function. Just as importantly, Podolski believed Androxal, unlike clomiphene, could be patented for the treatment of low testosterone in men.

    Podolski filed a patent for Androxal in July 2002, just over a year after Fisch's clomiphene patent was filed in October 2001. In that same year, Zonagen (now known as Repros) began clinical trials with Androxal.

    And then the "When Harry Met Joe" story turns ugly.

    "He stole my idea," says Fisch of Podolski, adding that Androxal only came into existence because Podolski violated his confidentiality agreement.

    "I didn't steal anything from Harry," answers Podolski. Yes, the idea for Androxal may have germinated with the Fisch meeting in New York City, Podolski adds, but Fisch's confidentiality agreement was null and void because the information it contained was already in the public domain.

    That Zonagen (now Repros) has now pushed Androxal into phase III studies and intends to seek U.S. approval next year, while Fisch has taken no steps to develop his clomiphene idea into a viable business further supports his case, says Podolski.

    "If my patent is nothing to worry about, then why has Repros asked the U.S. patent office to re-examine my patent twice and lost both times," Fisch asks. "And why does Repros warn investors in its SEC filings that the company is potentially in violation of my patent?"

    Fisch's clomiphene patent has withstood two challenges, including an appeal before a federal judge. But Wall Street has generally sided with Repros in the ongoing patent dispute, believing the company will eventually reach a financial settlement with Fisch. The doctor will be paid and he'll go away, is the operating assumption made by many investors.

    "They're wrong," says Fisch. "They figured I wouldn't last this long, but this is personal for me. I plan on winning in the way I want to win and that will include an apology."

    "Harry is going to sue us. I guarantee that, but our lawyers believe we have freedom to operate with our patent," says Podolski.

    "I don't care what he believes," says Fisch of Podolski. "We're not talking theology here."

    And what is Fisch's next step? He won't say exactly but he did offer a clue.

    "Joe wouldn't have come up with the idea for Androxal without having met me... He has a very weak patent. There's a 90% likelihood that the Repros patent will be challenged and will not survive. My patent, however, will survive."
     
  8. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Wiehle R, Cunningham GR, Pitteloud N, et al. testosterone Restoration by Enclomiphene Citrate in Men with Secondary Hypogonadism: Pharmacodynamics and Pharmacokinetics. BJU International. Testosterone Restoration by Enclomiphene Citrate in Men with Secondary Hypogonadism: Pharmacodynamics and Pharmacokinetics - Wiehle - BJU International - Wiley Online Library

    Objectives - To determine the pharmacodynamic (PD) profile of serum total testosterone levels (TT) and luteinizing hormone (LH) in men with secondary hypogonadism following initial and chronic daily oral doses of enclomiphene citrate in comparison to transdermal testosterone. To determine the effects of daily oral doses of enclomiphene citrate (Androxal®) in comparison to transdermal testosterone on other hormones and markers in men with secondary hypogonadism.

    Patients and Methods - This was a randomized, single blind, two-center phase II study to evaluate three different doses of enclomiphene citrate (6.25mg, 12.5mg and 25 mg Androxal®), versus androgel®, a transdermal testosterone, on 24-hour LH and TT in otherwise normal healthy men with secondary hypogonadism. Forty-eight men were enrolled in the trial (ITT Population), but 4 men had T levels >350 ng/dL at baseline. Forty-four men completed the study per protocol (PP population). All subjects enrolled in this trial had serum TT in the low range (<350 ng/dL) and had low to normal LH (<12 IU/L) on at least two occasions.

    TT and LH levels were assessed each hour for 24 hours to examine the effects at each of three treatment doses of enclomiphene versus a standard dose (5 grams) of transdermal testosterone (AndroGel). In the initial profile TT and LH were determined in a naïve population following a single initial oral or transdermal treatment (Day 1). This was contrasted to that seen after six weeks of continuous daily oral or transdermal treatment (Day 42). The pharmacokinetics of enclomiphene was performed in a select subpopulation. Serum samples were obtained over the course of the study to determine levels of various hormones and lipids.

    Results - After six weeks of continuous use, the mean ± SD concentration of TT at Day 42 C0hrTT, was 604 ± 160 ng/dL for men taking the highest of dose of enclomiphene citrate (enclomiphene, 25 mg daily) and 500 ± 278 ng in those men treated with transdermal testosterone. These values were higher than Day 1 values but not different from each other (p = 0.23, T-test). All three doses of enclomiphene increased C0hrTT, CavgTT, CmaxTT, CminTT and CrangeTT. Transdermal testosterone also raised TT, albeit with more variability, and with suppressed LH levels. The patterns of TT over 24 hour period following six weeks of dosing could be fit to a non-linear function with morning elevations, mid-day troughs, and rising night-time levels. Enclomiphene and transdermal testosterone increased levels of TT within two weeks, but they had opposite effects on FSH and LH Treatment with enclomiphene did not significantly affect levels of TSH, ACTH, cortisol, lipids, or bone markers. Both transdermal testosterone and enclomiphene citrate decreased igf-1 levels (p<0.05) but suppression was greater in the enclomiphene citrate groups.

    Conclusions - Enclomiphene citrate increased serum LH and TT; however, there was not a temporal association between the peak drug levels and the Cmax levels LH or TT. Enclomiphene citrate consistently increased serum TT into the normal range and increased LH and FSH above the normal range. The effects on LH and TT persisted for at least one week after stopping treatment.
     
  9. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Repros Seeks to Affirm Its Intellectual Property Rights in Androxal(R)
    Repros Seeks to Affirm Its Intellectual Property Rights in Androxal(R) (NASDAQ:RPRX)

     
  10. Michael Scally MD

    Michael Scally MD Doctor of Medicine

  11. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Repros Reports Preliminary Findings: Second Pivotal Study and 6-Month Safety Study Support Androxal(R) Approvability
    Repros Reports Preliminary Findings: Second Pivotal Study and 6-Month Safety Study Support Androxal(R) Approvability (NASDAQ:RPRX)

    • Androxal meets both co-primary endpoints in second pivotal study ZA-302
    testosterone normalized in 81% of patients
    • No deleterious effects on sperm function
    • No excursions above normal in 24 hour average testosterone
    • Androxal is generally well tolerated in 6 month safety study ZA-300
    • No dose dependent adverse events
    • Adverse event profile similar or superior to other approved testosterone therapies with over 90% of safety database collected
    • NDA submission on track

    Repros Therapeutics Inc.® (Nasdaq:RPRX) today reported topline results from both the second pivotal efficacy study as well as the 6 month safety study of Androxal® in the treatment of men with secondary hypogonadism. Secondary hypogonadism is the largest subset of hypogonadal men accounting for greater than 85% of the reported cases. Recent scientific publications, confirmed by Company experience, suggest obesity is the single greatest cause for hypogonadism. Subjects in all ongoing Androxal studies were required to exhibit morning testosterone (T) levels of < 300 ng/dL on two separate consecutive mornings, be under 60 years of age and have a BMI over 25.

    All men started at the lower 12.5 mg dose but up-titrated at any time during the study if their morning testosterone was < 450 ng/dL in the 6 month study and < 300 ng/dL in the efficacy study. The lower up-titration threshold was dictated by the FDA for the efficacy study. The Company believes a level of 450 ng/dL or higher will confer the desired clinical benefits of testosterone, including metabolic and quality of life improvements.
     
  12. Michael Scally MD

    Michael Scally MD Doctor of Medicine

  13. Michael Scally MD

    Michael Scally MD Doctor of Medicine

  14. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Expect more problems from the FDA. RPRX is a con.

    Repros Receives FDA Guidance For Androxal(R) Clinical Program
    Repros Receives FDA Guidance For Androxal(R) Clinical Program (NASDAQ:RPRX)

    • FDA instructs Repros to request meeting to discuss adequacy of studies ZA-301 and ZA-302 as evidence of pivotal efficacy
    • FDA will now consider label claims versus approved testosterone products if superiority can be demonstrated
    • FDA confirms current safety package acceptable pending final outcomes
    • FDA now requires 1 year exposure for men up-titrated to high dose in DEXA study
    • Company now guides to a 2nd half 2014 NDA submission
    • FDA will consider priority review at time of NDA submission
     
  15. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    FDA Recommends Sperm Endpoints as Key Parameters for Assessment of Androxal(R) Versus Approved Topical Gel
    FDA Recommends Sperm Endpoints as Key Parameters for Assessment of Androxal(R) Versus Approved Topical Gel (NASDAQ:RPRX)

    THE WOODLANDS, Texas, April 30, 2014 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that it has received guidance from the Food and Drug Administration (FDA) regarding primary endpoints for the two studies, ZA-304 and ZA-305, that Repros is currently conducting of Androxal® against a leading approved testosterone gel. The FDA stated that sperm concentration reductions should take into consideration recognized thresholds for fertility treatments, and also that the clinical significance of the degree of sperm concentration decline between the beginning and end of the treatment period is important, as it may represent an adverse effect on fertility, even if sperm concentration stays in the normal range. To address these issues, the FDA recommended, "Show that the enclomiphene-treated men are significantly more likely to maintain normal sperm concentrations compared to those treated with your testosterone active control. Also show that the enclomiphene-treated men have a significantly smaller decline in total sperm concentrations as compared to your testosterone active control. This approach would involve a co-primary efficacy endpoint. Both components of the co-primary efficacy endpoint should show statistically significant and clinically relevant differences (you will need to justify the clinical relevance of the observed differences). Other important endpoints should include other semen parameters, testosterone concentrations and comparisons between your product and placebo and between testosterone and placebo. If there are no meaningful differences between your product and testosterone or between testosterone and placebo, we will question the utility of your product."

    The FDA further stated that, rather than a cutpoint of 15 million sperm/mL, a 10 million sperm/mL, which is recognized as the threshold for needing invitro fertilization, and a 20 million sperm/mL, which is recognized as the threshold for needing intrauterine insemination in infertile couples, might be more clinically relevant cutpoints for defining low sperm counts and thresholds below which an absolute negative effect on spermatogenesis could be substantiated. While the FDA strongly recommended in its guidance that the Company resubmit the revised protocols before initiating the trials, the Company instead has substantially enrolled the trials and plans to continue to engage the FDA, during the conduct of the trials and before unblinding the data, in discussion of the specifics of the spermatogenesis endpoints in order to meet FDA expectations. The Company notes that men enrolled into the study are clearly hypogonadal and fertile as determined by central laboratory assessments. These criteria have been consistently referenced in FDA correspondence. Furthermore, the Company believes, based on its experience with Androxal® and exogenous testosterone products, that the studies are well powered to meet any permutation of the comparative sperm endpoints outlined in the FDA guidance.

    The primary endpoint and statistical analysis plan outlined for studies ZA-304 and ZA-305, described below, are being modified to comply with the FDA suggestions. The Company believes that it remains on track for the submission of an NDA for Androxal® by the end of 2014.
     
  16. Michael Scally MD

    Michael Scally MD Doctor of Medicine

  17. Michael Scally MD

    Michael Scally MD Doctor of Medicine

  18. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    RPRX "PumP" Podolski PR

    "Pump" Podolski recently put our a PR touting the success of Androxal (below). Well, by this time all should be looking for what is unsaid rather than what is said.

    It is finally very clear that approval is based on fertility and NOT TT as "PumP put out on numerous occasions over the past years. The FDA shut this down long ago, but that didn't stop PumP.

    Another piece of misinformation put out by PumP over the years was how those on topical TRT were just plain infertile. He declared that they weren't just minus some sperm, but outright demolished. Why he even put out PRs stating as much.

    It is clearly seen by the TRT literature which shows a roughly 50% might be infertile. But, more so, common sense says this was not true or it would have been all over the news that TRT was also as good as a male contraceptive.

    I was sure if he ever maintained that stance, he would be quickly found out to be committing data fraud. Anyone familiar with PumP knows he is an expert as misinformation and misrepresentation (lies).

    The PR declares that BOTH co-primary endpoints were reached. BUT, PumP doesn't mention that THIRD co-primary endpoint. "Percentage of men that exhibit sperm = 10 million/mL at the end of 16 weeks of dosing and testosterone in the normal range, comparing Androxal®to a testosterone gel as well as comparing Androxal® to placebo." http://ir.reprosrx.com/releasedetail.cfm?ReleaseID=860148

    Anyway, my point is the PR shows the sperm count on TRT to be 45 MILLION. FERTILE!!! They are fertile by WHO standards. REALLY REALLY FERTILE.

    So, it will come down to how the FDA approaches the data. It makes me very suspicious the FDA would pass on a % change when it means nothing clinically. I mean NADA/ZIP/ZERO.

    Then, there is the absence of QoL data. SERMs are a very poor "TRT." It is a rare male that chooses a SERM for TRT. SERMs are currently available in many forms - clomiphene, tamoxifen, Raloxifene - and are basically NOT used. Androxal is the trans-isomer of Clomiphene. This is to bring out the point that even if the FDA approved Androxal, which I doubt, the market is absent.

    They could find utility in restoring HPTA function after stopping TRT or non-prescription AAS. Here, they would be used short term. But, that is not the IND. There is the problem of SERMs already available.

    In the past, I wrote many times about PumP, including the SPRM (Proellex) demise. Androxal will eventually suffer a similar fate, but not before PumP can use the RPRX ATM to exhaustion.
     
  19. Michael Scally MD

    Michael Scally MD Doctor of Medicine

  20. Michael Scally MD

    Michael Scally MD Doctor of Medicine