Repros Therapeutics Inc. (RPRX) On Monday announced it has received the official FDA minutes of the meeting held on May 9th to discuss the pivotal and safety studies that will be required to be completed before an NDA for Androxal can be submitted.
Repros noted that the FDA minutes confirm that the specifics for the pivotal studies will be defined under a Special Protocol Assessment or "SPA". The Company resubmitted the SPA on May 22nd and made an announcement on that same day. PDUFA requirements ensure that the FDA will respond within 45 calendar days of submission.
The minutes also stated a safety exposure requirement of 100 men for one year and 800 men for 6 months are necessary for the NDA submission. Depending on enrollment in the already planned studies, the Company believes it could submit the NDA in late 2013 or in the first quarter of 2014.
The company said it believes over 100 men from previous or ongoing studies will have received Androxal for at least a year by late summer. In addition, the Company has been enrolling men into a 500 subject open label safety study at 31 sites in the US.
Repros said it continues to believe Androxal is safe and effective. Supporting this belief, completed studies comparing Androxal to approved topical gels demonstrate Androxal's efficacy to be equivalent or greater than the gels, with fewer men withdrawing from the Androxal group due to adverse events than men in the gel group.
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