Repros Therapeutics Inc.(RPRX) Monday said the FDA has scheduled a meeting in May to discuss the design of pivotal Phase 3 efficacy studies for Androxal, as well as the components of the overall drug development program required for NDA submission.
Androxal is an oral therapy intended for the treatment of secondary hypogonadism. Unlike the hormone replacement therapies currently approved to treat this disorder, Androxal restores testicular function resulting in normal synthesis of testosterone and continued spermatogenesis.
Repros said studies using approved testosterone replacement therapies as efficacy and safety comparators have shown the approved treatments result in suppression of important pituitary hormones that drive testicular function down to castration levels in a significant number of men.
Joseph Podolski, president and CEO of The Woodlands, Texas-based company, said," Our goal is to work with the FDA to provide a complete drug dossier for Androxal that exhibits the products' clinical benefit and safety. Depending on FDA comments, we believe we can submit the NDA early in 2014."
RPRX closed Monday's regular trade at $4.35, down $0.15 or 3.33%, on the Nasdaq. In the after-hours, the stock gained $0.01 or 0.23%. Over the past year, the stock traded in a range of $3.34 - $6.85.
by RTT Staff Writer
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