Camurus AB (STO: CAMX), a Swedish research-based pharmaceutical company, announced on Monday the assignment by the US Food and Drug Administration (FDA) of a Prescription Drug User Fee Act (PDUFA) goal date of 26 December 2018 for its investigational weekly and monthly buprenorphine depots, CAM2038, for the treatment of adults with opioid use disorder (OUD).

Reportedly, the FDA considers the resubmission of the New Drug Application (NDA) by Camurus' US partner Braeburn a complete response to the 19 January 2018 action letter.

CAM2038 has demonstrated the potential to improve clinical outcomes compared to standard treatment and could significantly reduce the risks, burdens and stigma associated with daily medication. If approved, CAM2038 would be the first long-acting treatment for OUD available in both weekly and monthly formulations for use through all stages of a patient's treatment journey.

Formulated with Camurus' proprietary FluidCrystal injection depot technology, CAM2038 is designed to enable dose matching to existing sublingual buprenorphine formulations and for treatment initiation without the need to first stabilise patients on daily transmucosal buprenorphine products.

In November 2017, the FDA's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee had jointly voted 17-3 for recommending approval of CAM2038. The Advisory Committee's recommendation was based on a review of results from seven phase 1-3 clinical trials, five of which were in patients with opioid dependence.

According to the company, a core component of the NDA submission is the positive results from a pivotal phase 3 randomised, double-blind, double -dummy, active-controlled study of CAM2038 versus daily sublingual buprenorphine naloxone in patients with OUD, recently published in JAMA Internal Medicine.

CAM2038 is under regulatory review for marketing authorisation in the EU and Australia.

Camurus is committed to developing and commercialising innovative and differentiated medicines for the treatment of severe and chronic conditions.