Pain Therapeutics, a clinical stage biopharmaceutical company, has petitioned the US Food and Drug Administration (FDA) regarding a complete response Letter for Remoxy issued in August this year, it was reported yesterday.
The FDA and the firm have agreed to meet in-person on 31 January 2019 to discuss this matter. The company disagrees with recent FDA comments and conclusions regarding the product's abuse-deterrent properties and the drug's overall risk/benefit profile.
Remoxy is the proposed trade name for a new type of abuse-deterrent, twice-daily, capsule gel formulation of oxycodone. It has physical/chemical properties intended to deter abuse, compared to marketed extended-release oxycodone products.
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