injectable testosterone undecanoate

[cvictorg]

Is this being prescribed for hrt in the United States? Nebido

The safety and efficacy of injectable testosterone undecanoate during routine clinical management of hypogonadism: an analysis from a long-term ?real-life? study

Patients received intramuscular injections of 1000 mg TU at treatment visits separated by intervals of 610 weeks (after the first injection) or 1014 weeks (after all subsequent injections). Here, we report the findings of an analysis performed at the end of the interval following the tenth injection (1.82.6 years after patient entry into the study). The primary endpoint of the study was the serum level of prostate-specific antigen (PSA; assessed at baseline and at alternate treatment visits). Secondary variables included trough total testosterone levels (assessed at baseline and all treatment visits).

Results: A total of 77 patients (mean (standard deviation) age, 47.8 (11.6) years) were included in this analysis. Mean PSA levels remained close to baseline throughout (baseline: 0.81 (0.78) ng/ml; before ninth injection: 1.14 (1.1) ng/ml). Mean haematocrit remained with the normal range, and treatment was generally well tolerated. Trough total testosterone levels were restored to the physiological range after the second injection and throughout the remainder of the study (baseline: 5.8 (3.0) nmol/l; before tenth injection: 13.6 (3.7) nmol/l).

Clinical experience with a new long-acting injectable testosterone undecanoate

http://www.agingmale2006.com/abstracts/abs_sag_nebido_hypogonadal_men.asp

Design: We report data from 22 patients (15 with primary and 7 with secondary hypogonadism) aged 30 to 65 years (mean 43.8 8 years) who received injections of 1000 mg of TU (4ml - ampoules) for over 8 years.

Results: The medication was well tolerated and local irritation of the injection site was moderate and did not exceed a duration of 3 days. Serum trough levels of testosterone were generally within the low normal range, indicating sufficient substitution. Individual dosing intervals ranged from 10 to 14 weeks. In accordance, patients reported restoration of sexual functions and convenient changes in mood patterns, e.g. gain of vigour and loss of depressiveness. In contrast to short-acting testosterone esters, sensation of fluctuations in androgen concentrations was rarely reported. If this was the case, it was within the last 2 weeks before the next injection as loss of androgenic psychotropic effects. Haemoglobin concentrations and hematocrit were markedly elevated under treatment but remained within the normal range. Prostate size as assessed by transrectal ultrasound remained below 30 ml in all patients and PSA concentrations did not exceed 2.0 g / L. Bone density as determined by quantitative computer tomography of the lumbar spine or phalangeal ultrasound generally improved in all patients.

Conclusion: In summary, intramuscular injections of testosterone undecanoate represent a feasible, safe and well tolerated modality of androgen substitution in hypogonadal men.

Primate study

Pharmacokinetics and Degree of Aromatization Rather Than Total Dose of Different Preparations Determine the Effects of Testosterone: A Nonhuman Primate Study in Macaca fascicularis -- Weinbauer et al. 24 (5): 765 -- Journal of Andrology

Intramuscular Injections of Testosterone Undecanoate Restores and Maintains Testosterone Levels in Hypogonadal Men: Presented at AUA

News - Intramuscular Injections of Testosterone Undecanoate Restores and Maintains Testosterone Levels in Hypogonadal Men: Presented at AUA

This phase 3, multicentre, open-label, randomised trial was designed to assess the safety, efficacy, and pharmacokinetics of testosterone undecanoate intramuscular injections. In the study, men with hypogonadism and low serum testosterone levels were treated with 3 intramuscular injections of testosterone undecanoate every 10 weeks.

"This form of testosterone treatment would require only 5 injections per year," said Dr. Morgentaler, "[making it] an appealing alternative for many men who may object to existing testosterone treatments such as twice-monthly injections or daily skin applications."

In the trial, 130 men aged at least 18 years who had serum testosterone levels <300 ng/dL received intramuscular testosterone undecanoate at a dose of 750 mg at baseline, at week 4, and at week 14. They were followed for an additional 10 weeks.

At the end of the study, 94% of patients reached and maintained normal serum testosterone levels.


Intramuscular Testosterone Undecanoate: Pharmacokinetic Aspects of a Novel Testosterone Formulation during Long-Term Treatment of Men with Hypogonadism -- Schubert et al. 89 (11): 5429 -- Journal of Clinical Endocrinology & Metabolism

 

[Michael Scally MD]

As you probably know, testosterone undecanoate is approved for use in Europe as Nebido. It is not approved in the USA. Endo Pharmaceuticals received another disappointing FDA requirement.

Endo Pharmaceuticals Provides Regulatory Update on AVEED(TM) (Testosterone Undecanoate) Injection

CHADDS FORD, Pa., Dec. 3 /PRNewswire-FirstCall/ -- Endo Pharmaceuticals (Nasdaq: ENDP) today announced that it received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for its extended-duration testosterone undecanoate injection, AVEED(TM), for men diagnosed with low testosterone. Low testosterone is also known as hypogonadism.

In the complete response letter, the FDA has requested information from Endo to address the agency's concerns regarding very rare but serious adverse events, including post-injection anaphylactic reaction and pulmonary oil microembolism. The letter also specified that the proposed Risk Evaluation and Mitigation Strategy (REMS) is not sufficient.

Endo is currently evaluating the FDA's complete response letter.

Endo Pharmaceuticals - News Release

 

[cvictorg]

As you probably know, testosterone undecanoate is approved for use in Europe as Nebido. It is not approved in the USA. Endo Pharmaceuticals received another disappointing FDA requirement.



Endo Pharmaceuticals - News Release

FDA denies approval to long acting testosterone injections

UPDATE 3-US FDA declines to approve Endo testosterone drug | Reuters

NEW YORK, Dec 3 (Reuters) - U.S. health regulators declined to approve Endo Pharmaceuticals Holdings Inc's (ENDP.O) drug for low testosterone, requesting more information about rare but serious side effects, the specialty drugmaker said on Thursday, sending its shares down nearly 4 percent.

The U.S. Food and Drug Administration wants information about anaphylactic reactions following injection of the drug, and about events when a poor injection technique leads to oil leaking into the lung, causing coughing.

In its so-called complete response letter, the agency also said Endo's proposed strategy to mitigate risks for the drug, Aveed, was not sufficient.

Endo said it was evaluating the FDA letter. The drug is sold outside the United States by Germany's Bayer AG (BAYGn.DE) and is available in more than 50 countries under the brand name Nebido. Endo licenses Aveed from Bayer.

Jefferies & Co analyst Corey Davis said Endo may choose to end its development of the drug if it cannot resolve the FDA's concerns.

"It's hard for us to imagine what the company could do to satisfy FDA concerns over exceedingly rare events that we would guess are not even product-specific in the first place," Davis said in a research note.

However, Davis said consensus estimates for Aveed sales had been "relatively modest" at $94 million by 2012.

An Endo spokesman said it was not yet clear what the next steps for the product would be. "Our goal is to work closely with the agency," the spokesman, Kevin Wiggins, said.

Aveed was one of the main products Endo acquired earlier this year in its $370 million purchase of Indevus Pharmaceuticals, a deal designed to expand its product line beyond pain treatments.

"It clearly casts a cloud on their ability to make acquisitions," said Jim Molloy, an analyst with Caris & Co. "They made it very clear they are looking to acquire more things. This one didn't go so well, so there's going to be some scrutiny on what the next one will be."

Low testosterone, also known as hypogonadism, is linked to symptoms such as fatigue, loss of muscle mass and decreased libido, and there is increasing evidence of an association with conditions such as diabetes and cardiovascular disease, according to Endo.

The Aveed action marks the second regulatory setback for Endo in as many months related to a testosterone product. In October the FDA delayed approval of Endo's Fortesta, a gel for men with low testosterone.

In September the FDA extended its review of Aveed by three months.

Endo shares fell 86 cents, or 3.8 percent, to $21.56 in afternoon trading on Nasdaq.

Guess I'll have to get it another way