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.”

 

 


The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 33,200+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Clinical Scientist
Molecular Templates Jersey City, NJ
Manufacturing Associate - GMP Upstream
Molecular Templates Austin, TX
Director, Regulatory Affairs
Molecular Templates Jersey City, NJ
GMP Supervisor - Downstream
Molecular Templates Austin, TX
Manufacturing Associate - GMP Downstream
Molecular Templates Austin, TX

Visit Endpoints Careers ->