Drugs

Pain Therapeutics Appeals Denial of Pain Drug

David McFarland

— 1 min read
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Pain Therapeutics has appealed an August-issued FDA complete response letter (CRL) for Remoxy, an abuse-deterrent, extended-release form of oxycodone. The agency and the company have agreed to meet 1/31/2019 to discuss the action.

 

According to the company, the CRL said data submitted in the company’s NDA did not support the conclusion that the benefits of Remoxy outweighed the risks. At the time it was issued, company president Remi Barbier said: “This is a bizarre conclusion to reach, especially during a time of staggering human and economic toll created by opioid abuse and addiction. 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 judgment call that is vague in nature but conclusive in its damaging effects.”

The CRL followed a June meeting 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.

The company has outlined areas of dispute it will address with FDA at its meeting, such as:

  • When corrected for math errors, material mistakes and misrepresentations made by FDA during the advisory committee meeting, Remoxy has properties that may deter against common methods of abuse, such as injection; 
  • Based on a fair, neutral and impartial review of data, there is overwhelming evidence that Remoxy may be less abusable than similar marketed 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 says it is requesting a neutral re-examination of its data, further discussion and a fair resolution of the matter.

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