Pain Therapeutics Appeals FDA Decision on REMOXY

On Nov 13, 2018

Pain Therapeutics announced that it has petitioned the Food & Drug Administration (FDA) regarding a Complete Response Letter (CRL) for REMOXY issued August 2018. The FDA and the Company have agreed to meet in-person on January 31, 2019 to discuss this matter.

REMOXY is the proposed trade name for a new type of abuse-deterrent, twice-daily, capsule gel formulation of oxycodone. REMOXY has physical/chemical properties intended to deter abuse, compared to marketed extended-release oxycodone products.

“The opioid crisis rages on, yet deficiencies of certain prescription opioid drugs are still with us,” said Remi Barbier, President & CEO of Pain Therapeutics. “It’s a matter of national interest to address these deficiencies head-on, even if it means taking certain opioid drugs off the market. We don’t need regulatory runarounds. We need comprehensive and humanitarian solutions to the opioid crisis, including taking steps to stop drug abuse, curb unneeded opioid prescriptions, and reduce the risk of opioid use disorder in pain patients.”

Pain Therapeutics disagrees with recent FDA comments and conclusions regarding REMOXY’s abuse-deterrent properties and the drug’s overall risk/benefit profile. Based on the totality of scientific evidence, the Company believes:

When corrected for math errors, material mistakes and misrepresentations made by FDA during a June 2018 Advisory Committee, REMOXY has properties that may deter against common methods of abuse, such as injection abuse;
Based on a fair, neutral and impartial review of data, there is overwhelming evidence that REMOXY may be less abusable than marketed extended-release oxycodone products;
Excipients in REMOXY may pose a lower risk of health problems and possess a higher margin of safety compared to marketed extended-release oxycodone products; and
REMOXY meets all evidentiary standards for drug approval and its proposed indication.

For these and other reasons, Pain Therapeutics is requesting a neutral re-examination of its data, further discussion and a fair resolution of this matter.