ARTICLE | Clinical News

Lipocine receives negative panel vote

January 12, 2018 4:24 PM UTC

Lipocine Inc. (NASDAQ:LPCN) said FDA's Bone, Reproductive and Urologic Drugs Advisory Committee voted 13-6 that the benefit-risk profile of Tlando testosterone undecanoate is not acceptable to support its approval to treat hypogonadism. Its PDUFA date is May 8.

In a briefing document released ahead of the meeting, FDA raised concerns regarding Tlando's effects on blood pressure, lipid parameters and hematocrit, and its potential to increase the risk of adverse cardiovascular outcomes. The agency also noted that in the most recent trial supporting a resubmitted NDA for Tlando, it missed all three standard secondary endpoints for testosterone therapies that assess for unacceptably high maximal exposures to testosterone...

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