Braeburn Pharmaceuticals and Camurus announced that the Food and Drug Administration (FDA) has granted Fast Track designation to CAM2038, buprenorphine subcutaneous injection products, for the treatment of opioid addiction.

The companies also announced that the first patient has been dosed in a multi-site Phase 2 study designed to assess the effectiveness of CAM2038 in blocking the effects of other opioids. Results of this study are expected to guide with the optimization of these patients’ individualized treatment, including during early stages of recovery. CAM2038 has previously been evaluated in 176 healthy volunteers in three Phase 1/2 clinical trials demonstrating a promising drug release, safety, and tolerability profile.

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CAM2038 are investigational buprenorphine subcutaneous injection products being developed as once-weekly and once-monthly formulations for all treatment phases of opioid addiction, from initiation through maintenance. They are designed for administration by healthcare personnel to ensure proper delivery that minimizes the risks of diversion, abuse, misuse, and accidental exposure.

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