This week, the FDA declined to approve a new extended-release opioid painkiller developed by Pain Therapeutics.
The medication, Remoxy, is a long-acting form of oxycodone, a widely abused narcotic. But Pain Therapeutics had banked on the formula’s abuse-deterrent properties to win approval for U.S. release. The FDA, however, was apparently unpersuaded, and said the benefits of the new medication did not outweigh the risks.
In a statement, the company’s CEO, Remi Barbier, called the FDA’s conclusion “bizarre,” considering the market need for painkillers that are less likely to be abused.
“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 judgment call that is vague in nature but conclusive in its damaging effects,” he said.
In response to the FDA rejection, the company said it plans to shake up its strategic focus and put more effort into its pipeline of Alzheimer’s treatments.