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# FDA Again Rejects Pain Therapeutics’ Remoxy NDA
- URL: https://www.fdaweb.com/fda-again-rejects-pain-therapeutics-remoxy-nda/
- Published: 2016-09-27T12:00:00.000Z
- Updated: 2026-09-14T21:35:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136925

FDA has sent Pain Therapeutics a third complete response letter (CRL) on its NDA resubmission for Remoxy ER (oxycodone capsules), asking for “additional actions and data” before considering approval again. The letter focuses on the drug’s abuse-deterrent properties and proposed drug labeling, according to the company, adding that it does not question clinical safety, drug efficacy, manufacturing, stability, bioequivalence or any other issues from a prior complete response letter.

Pain Therapeutics says it is evaluating the CRL and plans further discussions with the agency. “These actions may take approximately a year to conduct and may cost approximately $5 million, pending discussions with the FDA and outside clinical/regulatory consultants,” it says. 

FDA’s letter, according to Pain Therapeutics, recommends the following studies in order to obtain approval with label claims on three routes of abuse (i.e., injection, inhalation and snorting): 

- **To support a potential drug label claim against abuse by injection:** Repeat an injectability/syringeability study using thin films of drug, smaller volumes of solvents, additional mixed solvents and alternative extraction methods and syringe filter.
- **To support a potential drug label claim against abuse by inhalation:** Repeat a volatilization study using the same thickness for each drug to increase surface area.
- **To support a potential drug label claim against abuse by snorting:** Conduct an intranasal abuse potential study in human volunteers (i.e., not the animal data we had submitted) with drug applied directly inside the human nasal cavity.

“In addition, we had proposed in the Remoxy NDA a label claim against abuse by chewing,” the company says. “Our proposal was based on clinical results of an oral human abuse potential study that met all four co-primary endpoints with statistical significance and that also met several, but not all, secondary endpoints. The CRL asks us to submit a revised proposed label to indicate results of this study do not support a label claim against abuse by chewing.”

The NDA resubmission was filed in March despite Pfizer deciding in 2014 to discontinue its agreement to develop and commercialize Remoxy due to unresolved issues outlined in a 2011 complete response letter from the agency. Pfizer said at the time that its decision was based on an “internal review of the top-line results of five recently completed clinical studies required to address the complete response letter...”

A complete response letter was also sent in 2008 that asked for more non-clinical data to support the drug’s approval. That letter followed an advisory committee vote (11 to 8) recommending approval, although it said Remoxy’s label should say that it is tamper-resistant rather than the abuse-resistant statement the company wanted.