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Repros Low Testosterone Treatment Faces Another FDA Hurdle

Repros Low Testosterone Treatment Faces Another FDA Hurdle

Repros Therapeutics’ low testosterone treatment – Androxal – has hit another Food and Drug Administration (FDA) roadblock. The pharmaceutical developer had planned to attend a preapproval meeting with the agency next week, however that meeting has been canceled.

The FDA cites concerns over the company’s integral data on Androxal – a small-molecule therapy for the treatment of men with low testosterone – as the reason for the meeting’s cancellation. According to Repros, the meeting was cancelled “due to questions that arose late in the review regarding the bioanalytical method validation that could affect interpretability of certain pivotal study data.”

CEO Joseph Podolski held a conference call with analysts where he explained that the FDA was concerned about the lab chosen by Repros to conduct testosterone tests, and whether Androxal truly met its primary endpoint in the Phase III clinical trial. Podolski defends the Repros-chosen lab, saying that it is CLIA-certified and was a reliable conductor of the necessary assays.

The setback is just another in a long line of roadblocks for Repros and Androxal, that has lasted for 13 years. It’s evident that investors are losing patience with the drug’s lack of approval after over a decade; shares in Repros dropped by 55 percent following the announcement that the FDA would not be approving Androxal by the previously agreed-upon date of November 30.

Though Podolski didn’t comment on whether he believes Repros will need to run another Phase III clinical trial for Androxal, the FDA has “expressed its willingness to work with” the company through this issue. The company has a long history of both clinical and regulatory setbacks with the long-delayed testosterone treatment.

The FDA has expressed concerns before over the validity of the efficacy data on Androxal, but the company had high hopes that drug would finally be approved following the filing of the review application in April of this year. It looks like the company may need to do more to prove Androxal’s effectiveness over a placebo.