Shares of Pain Therapeutics Inc. (NASDAQ:PTIE) fell to a record low Wednesday after a US Food and Drug Administration advisory committee voted against the approval of Remoxy ER for the treatment of severe pain.
The pharmaceutical company has lost nearly three-fourths of their value, plunging to US$2.15 in morning trade.
Late Tuesday, the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the FDA voted 14 to 3 against Remoxy ER, 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.
While panel votes are not binding, the FDA usually follows committee recommendations. The FDA is expected to make a decision on Remoxy ER by August 7.
The overprescribing of addictive opioid painkillers to manage pain among patients has triggered a nationwide opioid addiction crisis in America. The vote comes against this backdrop as drug companies race to get new non-addictive painkillers to the market.
The Austin, Texas-based company licensed Remoxy ER from Durect back in 2002.
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