Regulatory, Restructuring, Setbacks

No surprise: FDA hands Pain Therapeutics another slapdown on Remoxy, forcing a quick restructuring

Just as expected, the FDA has once again hit Pain Therapeutics $PTIE with a rejection of its application to sell Remoxy. And the biotech’s CEO lashed out, calling the decision “bizarre” as it prepped a company-wide restructuring.

Remi Barbier

However they describe the move, it couldn’t have been unexpected. A panel of outside experts turned thumbs down on the application by a vote of 14 to 3 as the agency remains vigilant over any pain remedies that could prove vulnerable to abuse.

The biotech’s share price, recently crushed by the panel vote, plunged 20% this morning.

This is Pain’s fourth rejection on Remoxy. The biotech now plans to focus its remaining resources on a drug for Alzheimer’s, a disease that has defeated every therapy thrown at it for more than a decade.

There was no immediate word how many jobs would be cut in the reorganization, just that all will be revealed in the coming weeks.

“This is a bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction,” said Pain CEO Remi Barbier. “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 call that is vague in nature but conclusive in its damaging effects.”

 

 


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Biotech Investment Analyst
SV Health Investors Boston, MA
Research Scientist - Disease Biology
Recursion Pharmaceuticals Salt Lake City, UT
Senior Scientist - Predictive Pharmacology
Recursion Pharmaceuticals Salt Lake City, UT
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Cadent Therapeutics Cambridge, MA
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twoXAR Mountain View, CA

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