Swedish pharmaceutical company Camurus (NASDAQ STO:CAMX) said on Monday that it has received the US Food and Drug Administration's (FDA) Prescription Drug User Fee Act (PDUFA) goal date of 26 December 2018 for its investigational CAM2038 for the treatment of opioid use disorder (OUD).

Upon approval, 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, according to the company.

Based on the company's 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 stabilize patients on daily transmucosal buprenorphine products.

The US FDA's Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee had earlier recommended the approval of CAM2038 based on a review of results from the company's seven Phase 1-3 clinical trials, five of which were in patients with opioid dependence.

Additionally, CAM2038 is under regulatory review for marketing authorisation in the EU and Australia, stated the company.

Opioid use disorder and opioid-related overdose deaths are escalating global health problems, contributing to significant mental, physical and social adverse consequences that include transmission of infectious diseases, unintentional overdose, criminal activity and incarceration.