Endo Pharmaceuticals today won FDA approval for of Aveed™ ( testosterone undecanoate) injection for adult men with hypogonadism or “Low-T” associated with a deficiency or absence of testosterone.
Aveed is indicated to produce serum testosterone levels in the normal range through a single 3 mL (750 mg) intramuscular injection given once at initiation of therapy, again at four weeks, and then every 10 weeks thereafter.
Aveed also expands treatment options for men with low testosterone. Up to now, those options have consisted of injections of shorter-duration drugs, topical gels, and skin patches.
Expected to reach the market “in early March,” according to the company, Aveed will expand Endo’s branded men’s healthcare offerings, which include the testosterone gel Fortesta®, which more than doubled its 2012 sales last year, generating $65.86 million; and the testosterone enanthate injection CIII Delatestryl®, for which 2013 sales were not disclosed.
"We are focused on getting Aveed to market to ensure that appropriate patients have access to it," Endo’s president and CEO Rajiv De Silva said in a statement.
In approving Aveed, FDA cited data from an 84-week Phase III trial of hypogonadal men in the U.S. In the Phase III study, Aveed increased mean serum testosterone levels, maintaining them for up to 10 weeks at steady state (between weeks 14–24). Men enrolled in the study had an average age of 54 years and a serum total testosterone level of under 300 ng/dL.
Aveed was approved with a Risk Evaluation and Mitigation System (REMS) requiring prescriber education and certification as well as restricted product distribution.
The approval followed the drug’s fourth go-round with the agency after three earlier rejections. In the most recent turn-down last May, FDA sent the company a complete response letter requesting that the REMS include a Medication Guide as well as Elements to Assure Safe Use (ETASU) to mitigate the risks and severe complications related to post-injection reactions. The letter did not include requests for additional clinical studies.
It is not known what effect, if any, the earlier rejections may have had in the company’s evp of R&D and CSO Ivan P. Gergel departing the company on March 31. A company statement February 27 attributed the decision solely to Endo relocating its R&D operations to its new global headquarters to Ireland, as the company has re-domiciled in Ireland from Malvern, PA.
“Consequently, Ivan has chosen to evaluate opportunities outside of Endo,” according to the statement, in which De Silva thanked Gergel for “his dedicated service and significant contributions to our R&D organization over the past six years.”
After the third Aveed rejection, Endo announced the departure of two other company executives—COO Julie H McHugh and Alan G. Levin, evp and CFO—as well as a restructuring that eliminated 15% of the company’s workforce or some 700 jobs worldwide. Endo also said it would seek more acquisitions, sell its HealthTronics urological business and branded pharmaceutical early-stage discovery platform, and restructure its R&D effort.
In January, Endo said it sold HealthTronics to Altaris Capital Partners for up to $130 million—$85 million upfront, the rest tied to future operating performance milestones—after earlier shedding Healthtronics’ image-guided radiation therapy and anatomical pathology laboratory businesses for a total of about $25 million.
Endo Pharmaceuticals is a unit of Endo International; the company renamed itself from Endo Health Solutions February 28 after completing its approximately $2.7 billion cash-and-stock acquisition of Canadian-based Paladin Labs.