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# Collegium Wants Oxycodone ER Restrictions
- URL: https://www.fdaweb.com/collegium-wants-oxycodone-er-restrictions/
- Published: 2018-04-11T12:00:00.000Z
- Updated: 2026-09-14T23:58:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141200

Collegium Pharmaceutical is petitioning FDA not to approve any pending NDA for an extended-release (ER) oxycodone drug product, including Pain Therapeutics’ NDA for Remoxy ER, unless the product **(1)** bears abuse-deterrent labeling based on premarket studies conducted in each of the three categories in FDA’s 4/2015 guidance on abuse-deterrent opioids, and **(2)** demonstrates abuse-deterrence that is at least equivalent to or superior to approved ER oxycodone drug products for all routes of abuse such as Collegium’s Xtampza ER extended-release capsules.

Specifically, the [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2018-P-1448-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) asks that the agency: 

- apply existing standards for laboratory-based *in vitro* manipulation and extraction studies, including physical manipulation and both small and large volume extraction, before approving any opioid drug product with potentially abuse-deterrent properties, including Pain Therapeutics’ pending 505(b)(2) NDA for Remoxy ER; and
- · require that all oxycodone ER products currently labeled as abuse-deterrent be required to meet current standards set forth in the Abuse-Deterrence Guidance for Class 1, 2, and 3 data, or have their abuse-deterrent labeling removed (and, if appropriate, approval rescinded) within a reasonable period of time (not to exceed six months).

 The petition says that Purdue Pharma’s OxyContin extended-release tablets cannot meet the standards and FDA should take immediate action to revoke the abuse-deterrent labeling approved for OxyContin and reconsider if the benefits of the drug continue to outweigh the risks.