Camurus announced that the Food and Drug Administration (FDA) has deemed the resubmission of the New Drug Application (NDA) of CAM2038 (buprenorphine) by Braeburn as a complete response to the January 19, 2018 action letter. As a result, a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2018 has been assigned for the investigational weekly and monthly depots of buprenorphine for the treatment of adults with opioid use disorder (OUD).
Pending approval, CAM2038 may be the first long-acting treatment for OUD in both weekly and monthly formulations. The drug utilizes the Company’s proprietary FluidCrystal injection depot technology, which allows dose matching to existing sublingual buprenorphine formulations. Healthcare professionals can administer the product as a small dose volume (~0.6mL) subcutaneous injection. Also, it eliminates the need to first stabilize patients on daily transmucosal buprenorphine products prior to treatment initiation; no mixing or room temperature conditioning is required prior to administration.
The FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee previously voted 17-3 to recommend approval of CAM2038. This recommendation was supported by data from 7 trials, of which 5 trials involved patients with opioid dependence. Findings from the Phase 3, randomized, double-blind, double-dummy, active-controlled study comparing CAM2038 and sublingual buprenorphine/naloxone in patients with OUD were included in the NDA submission.
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