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# FDA Rejects Pain Therapeutics Remoxy NDA
- URL: https://www.fdaweb.com/fda-rejects-pain-therapeutics-remoxy-nda/
- Published: 2018-08-06T12:00:00.000Z
- Updated: 2026-09-15T00:23:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142039

FDA has issued Pain Therapeutics a complete response letter for Remoxy, an abuse-deterrent, extended-release form of oxycodone. According to the company, the letter said data submitted in the company’s NDA do not support the conclusion that the benefits of Remoxy outweigh the risks.  
  
“This is a bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction,” said company president **Remi Barbier** in response to the agency action. “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 judgement call that is vague in nature but conclusive in its damaging effects.”  
  
The complete response letter follows a June vote by members of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety Advisory Committee that voted 14-3 to recommend that it not approve the drug. At the joint committee meeting, Public Citizen Health Research Group co-founder **Sidney Wolfe** urged that Remoxy ER not be approved. Wolfe said that when the drug is chewed, it releases much more oxycodone than when swallowed. Thus, it actually would be abuse-enhancing, he said. He claimed that Remoxy’s modest effects in reducing intravenous and intranasal abuse would be undermined by the oral abuse.  
  
Pain Therapeutics now says it will reorganize its resources to advance drug and diagnostic assets in Alzheimer’s disease. The company believes its program in Alzheimer’s has “game-changing characteristics.” PTI-125, the lead drug candidate, is a small molecule that has a “unique mechanism of action for treating Alzheimer’s disease,” it says.