US FDA to decide this year on application for opioid addiction therapy

16 July 2018

Sweden’s Camurus (Nasdaq: CAMX) says the US Food and Drug Administration has provided an action date of December 26, 2018 for the firm’s regulatory filing for CAM2038, an investigational opioid use disorder (OUD) treatment.

The firm, and its North American development partner Braeburn Pharmaceutical (Nasdaq: BBRX), received a setback in January after the FDA requested additional information to complete its review.

After the application was re-filed, Camurus said: “The FDA considers the resubmission of the New Drug Application by Camurus' US partner Braeburn a complete response” to the agency’s request.

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