Repros Therapeutics Inc. recently provided an update on its phase III program for Androxal. The candidate is being evaluated for the treatment of secondary hypogonadism.
The company announced that it has completed the enrollment process for the one-year study, DEXA (ZA-303), evaluating the effects of Androxal on bone mineral density. The company completed the enrollment three months before the scheduled date. The company expects to file a New Drug Application (NDA) for Androxal primarily on the basis of data from the DEXA study by mid-2014.
The company plans to continue to enroll patients for study so that the safety requirement of minimum exposure of 800 patients for 6 months mandated by the US Food and Drug Administration (FDA) is fulfilled.
Repros Therapeutics is also conducting a six-month open label study, ZA-300 (n~500), to build a safety database as required by the FDA. The company has recruited 415 patients and expects to complete recruitment by the end of the first quarter of 2013.
We note that the Androxal phase III program also includes two pivotal phase III studies, ZA-301 and ZA-302. While the ZA-301 study is currently underway, enrollment for the ZA-302 is expected to completed shortly.
Repros Therapeutics is highly optimistic about the potential of Androxal. The company believes that the candidate offers a safer and more reliable treatment option for patients suffering from secondary hypogonadism than the currently available drugs for the disease.
We currently have a Neutral recommendation on Repros Therapeutics. The stock carries a Zacks Rank #3 (Hold) in the short run.
Pharma stocks, which currently look more attractive, are Targacept Inc. and Valeant Pharmaceuticals (VRX - Free Report) . Both these companies carry a Zacks Rank #1 (Strong Buy).