Instant Report

Date: 06-May-2021

Australian TGA Approves Key Label Updates To Camurus’ Buvidal To Treat Opioid Dependence

Camurus announced that the Australian regulatory agency, the Therapeutic Goods Administration (TGA), has approved key label updates to Buvidal Weekly and Buvidal Monthly (buprenorphine) modified-release solutions for injection.

The approval includes: a new higher Buvidal Monthly 160 mg dose, direct initiation onto Buvidal Weekly, removing the requirement to be stabilised on sublingual buprenorphine prior to commencing treatment with Buvidal and changing the contraindications in pregnancy and lactation to precautions.

In 2020 over 53,000 Australians received treatment for their opioid dependence, which represents a 4.7% increase on the previous year. This was the largest increase in treatment delivery in the past decade and has been attributed to the introduction of long-acting injectable buprenorphine treatment which has increased treatment access and capacity.

“This welcome approval by the TGA provides additional opportunities to individualize treatment with Buvidal according to patients medical needs”, says Fredrik Tiberg, PhD, president & CEO. “Aligned with the EU label, Australian patients can now be directly initiated directly onto Buvidal Weekly, allowing a rapid transfer to long-acting therapy and avoiding the need for daily dosing.”

Camurus will now initiate the process for reimbursement for the 160 mg dose through the Pharmaceutical Benefits Advisory Committee process.

Camurus is a Swedish science-led biopharmaceutical company committed to developing and commercialising innovative and differentiated medicines for the treatment of severe and chronic conditions.