Pain Therapeutics’ drug, Remoxy, was designed to be abuse-deterrent but was declined by the US Food and Drug Administration (FDA) after its benefits were judged not to outweigh its risks. The drug is a capsule formulation of the opioid oxycodone, with a high-viscosity drug mass designed to help prevent abuse.
The FDA works with the Drug Enforcement Administration (DEA) in an effort to end the current opioid crisis. The FDA has thus created a benefit-risk framework as a part of the drug approval process.
As such, a drug like Remoxy has to not just prove that it is effective but that it is more effective than any other treatment on the market. Remoxy has been declined three times previously, even after reformulating the drug to be abuse-resistant.
Pain Therapeutics did not respond to a request for comment but CEO Remi Barbier was outspoken in a statement released on the company’s website: “This is a bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction…I believe Remoxy received an ideological judgement call that is vague in nature but conclusive in its damaging effects.”
Current statistics reveal that 116 people die from opioid-related overdoses in the US every day. The FDA was not able to disclose a statement on this issue.
Pain Therapeutics will reorganize to work on their Alzheimer’s disease treatment pipeline.