FDA advisory panel votes against approval of Pain Therapeutics' Remoxy ER

Shares in Pain Therapeutics plunged more than 75 percent after the company said that an FDA advisory committee voted 14 to 3 against the approval of Remoxy ER (oxycodone) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The company, which licensed development and commercialisation rights for Remoxy ER from Durect, is seeking clearance of the analgesic drug with properties that can be expected to deter against injection, snorting and inhalation/smoking routes of abuse. The FDA is set to complete its review of the filing and issue a final decision by August 7.

The resubmission for Remoxy ER was made in February under the FDA's 505(b)(2) regulatory pathway, following a meeting with the agency last year.

In 2016, the FDA issued a complete response letter to Pain Therapeutics regarding a filing for Remoxy ER, with the regulator raising issues related to the drug's abuse-deterrent properties and its proposed labelling. The agency's rejection came after Pfizer ended its agreement with the company to develop Remoxy and follows similar rejections by the regulator in 2011 and 2008.

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