Intellipharmaceutics crashes as it gets thumbs down from FDA panel for Aximris

The US Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) have issued another negative vote on a opioid alternative pain drug within a matter of days.

On Thursday, panelists voted to not support the approval of Canadian firm Intellipharmaceutics International’s (TSK: IPCI) Aximris XR (oxycodone extended-release tablets) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. As a result, the company’s shares plunged more than 70% to C$0.25 by close of trading.

The Committees voted 24 to 2 against the voting question: "Do you recommend approval of AXIMRIS XR (oxycodone extended-release tablets) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate?"