Repros’ Androxal Primed For NDA Submission, But Outcomes Study Looms

07 Nov 2014

• By Lisa LaMotta

The testosterone drugmaker is confident that Androxal can gain approval and is on track to submit a filing with FDA this year, but talk of a cardiovascular outcomes study is still on the table.

Repros Therapeutics Inc. says Androxal is on track to be filed with FDA by year-end and that a cardiovascular outcomes study is not likely needed for approval. Yet, the large costly trial will likely be a post-marketing reality for the testosterone drug despite the company’s claims that it doesn’t have the same issues as testosterone replacement therapies.

The Woodlands, Texas-based biotech hosted a conference call Nov. 7 to convey to investors the specifics of its recent pre-NDA...