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Pain Therapeutics, Inc. (NASDAQ:PTIE) plunged 47.7 percent Monday after receiving a Complete Response Letter from the Food and Drug Administration for Remoxy’s New Drug Application.
What Happened
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The FDA rejected Pain’s lead asset and said the drug’s negatives outweigh its positives.
"The data submitted in [the] NDA do not support the conclusion that the benefits of [REMOXY] extended-release capsules outweigh the risks,” the FDA said in a statement.
Why It’s Important
As an abuse-deterring, extended-release form of oxycodone, Remoxy was Pain Therapeutics’ answer to the opioid crisis.
"This is a bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction," Pain Therapeutics CEO Remi Barbier said in a statement.
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"We have an innovative drug with a social purpose, and a staggering amount of data that easily supports best-in-class abuse deterrence versus OxyContin. We relied on the criteria of a fair, neutral and impartial regulatory review, as any sponsor would. Instead, I believe REMOXY received an ideological judgement [sic] call that is vague in nature but conclusive in its damaging effects."
DURECT Corporation (NASDAQ:DRRX), which licenses to Pain, fell more than 8 percent Monday morning, but ended up closing the day 2.1 percent higher.
What’s Next
Pain Therapeutics said it will redirect its resources to advance its Alzheimer’s assets.
"Alzheimer's disease is a therapeutic indication with a profound need for new treatments," Barbier said. "A reorganization of the company represents a natural and timely evolution of the strength of our program in Alzheimer's disease."
Details of the plan will be discussed on a conference call in the coming weeks, according to Pain Therapeutics.
Related Links:
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