Repros Therapeutics Inc. (RPRX) announced that it has received additional guidance from the FDA related to its secondary hypogonadism candidate, Androxal. The FDA suggested three co-primary endpoints for the two ongoing phase III studies – ZA-304 and ZA-305 – on Androxal.
The two identical, 17-week, double-blind ZA-304 and ZA-305 studies (n = 120 each) will compare the safety and efficacy of Androxal with a testosterone replacement therapy (topical gel) and placebo in restoring and maintaining testicular function.
The primary endpoints proposed by the FDA were comparing change in sperm concentration in patients receiving Androxal as compared to patients on the leading testosterone replacement therapy in the U.S. and the proportion of men obtaining a testosterone in the normal range. The FDA also recommended comparing the percentage of men that exhibit sperm ≥ 10 million/mL and testosterone in the normal range using Androxal, testosterone gel and placebo at the end of 16 weeks of dosing.
Repros is modifying the primary endpoints and statistical analysis plan for ZA-304 and ZA-305 to incorporate the suggestions made by the FDA. However, this will not affect the schedule for study completion. Repros expects to submit a new drug application (:NDA) to the FDA for Androxal for the secondary hypogonadism indication by the end of this year.
Currently prescribed therapies for secondary hypogonadism include AbbVie Inc.'s (ABBV) AndroGel.
Repros currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include BioMarin Pharmaceutical Inc. (BMRN) and Biogen Idec Inc. (BIIB), each carrying a Zacks Rank #1 (Strong Buy).
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