Pain Therapeutics Shares Reeling After FDA Vote

Health and Healthcare

Published: June 27, 2018 12:10 pm

Last Updated: January 11, 2020 9:48 pm

Pain Therapeutics Inc. (NASDAQ: PTIE) shares were destroyed on Wednesday after a vote from the U.S. Food and Drug Administration (FDA) was announced. As we have said before, the FDA has the potential to make or break biopharmaceutical companies. In this case, Pain Therapeutics has been broken.

The FDA had a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee, which precipitated a vote of 14 to three against the approval of Pain Therapeutics’ Remoxy ER.

For some quick background: Remoxy ER is oxycodone extended-release capsules 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. Remoxy ER is also Pain Therapeutics’ lead product candidate.

Looking ahead, the FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 7, 2018, for completion of its review of the New Drug Application (NDA) for Remoxy ER.

Shares of Pain Therapeutics were last seen down about 70% at $2.55, with a 52-week trading range of $2.12 to $12.80.