Camurus setback benefits competitor Indivior

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for CAM2038, investigational buprenorphine weekly and monthly depot injections, for the treatment of adults with opioid use disorder (OUD), developed by Swedish drugmaker Camurus (STO: CAMX).

The FDA has requested additional information to complete the review. There is no need for new clinical studies and the agency’s requests will be addressed in a timely manner, said the Swedish firm. The North American rights to CAM2038 are licensed to Camurus’ partner, Braeburn Pharmaceutical (Nasdaq: BBRX).

However, what was bad news for Camurus and Braeburn, benefitted UK-based rival Indivior (LSE: INDV), whose drug Sublocade (buprenorphine extended-release) was approved by the FDA in December last year, and pushed the firm’s shares 3.1% higher to 413.5 pence yesterday.