Repros Therapeutics ($RPRX) is facing yet another setback for its long-delayed testosterone treatment as the FDA has backed out of a preapproval meeting and raised serious questions about the company's pivotal data.
The company was slated to go before an independent panel of FDA advisers next week to defend Androxal, a small-molecule treatment for low testosterone. But the agency has now canceled that meeting "due to questions that arose late in the review regarding the bioanalytical method validation that could affect interpretability of certain pivotal study data," Repros said.
What that boils down to, CEO Joseph Podolski told analysts on a conference call, is that the FDA has serious doubts about how Repros' chosen lab conducted testosterone tests in determining whether Androxal met its primary endpoint in Phase III. Podolski counters that the lab is CLIA-certified and ran its assays by the book.
Either way, investors seem to be running out of a patience with a drug program that has run for 13 years without an approval. Repros' shares fell more than 55% on the news as it became clear the FDA has no intention of approving Androxal by its previously stated Nov. 30 deadline.
The agency has "expressed its willingness to work with" the company on the issue, Repros said, but Podolski didn't say whether he expects to need to run another Phase III trial for the drug.
Androxal's latest setback follows years of fits and starts, clinical and regulatory. Repros has long struggled to convince the FDA that its drug works, repeatedly putting off filing Androxal for approval as the agency took issue with irregularities in its clinical data. Repros seemed to finally get on track in April when the agency accepted its application for review.
- read the statement