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Camurus announces PDUFA date for Brixadi for the treatment of opioid use disorder in the US firstwordpharma
June 28, 2021
Camurus announced today that the NDA by Camurus' US licensee Braeburn for Brixadi™ (buprenorphine) extended-release weekly and monthly injection for subcutaneous use for moderate to severe opioid use disorder was accepted for review by the FDA.
Camurus Announces Positive Outcome of Court Proceeding for Approval of Brixadi americanpharmaceuticalreview
July 24, 2019
Camurus announces the United States District Court for the District of Columbia grants Braeburn's motion for summary judgement, vacating the U.S. Food and Drug Administration's (FDA) decision to block final market approval of Brixadi™ Monthly.
Braeburn and Camurus’ Phase III opioid use disorder trial a success europeanpharmaceuticalreview
May 07, 2019
Braeburn Pharmaceuticals and Camurus announced positive results from Phase 3 trial supporting the safety and efficacy of CAM2038 in opioid use disorder…
Buvidal Weekly and Buvidal Monthly (CAM2038) approved in Australia as the first long-acting treatment of opioid dependence firstwordpharma
November 29, 2018
Camurus announced today that the Australian Therapeutic Goods Administration (TGA) has approved the company's lead products Buvidal® Weekly and Buvidal® Monthly (CAM2038) for maintenance treatment of opioid dependence within a framework of medical, social
Camurus Receives EU Approval for Weekly and Monthly Buvidal americanpharmaceuticalreview
November 29, 2018
Camurus announced the European Commission (EC) has approved weekly and monthly Buvidal (prolonged release buprenorphine) for the treatment of opioid dependence in adults and adolescents from 16 years of age. .....