OUD is a complex and potentially life-threatening condition with a significant negative impact on the individual, their families, and society. The US prevalence of OUD is estimated to be between 6–7 million people2; of these approximately 3 million are diagnosed with OUD, with about half receiving medical treatment.3,4
"The opioid crisis continues to weigh heavily on US society with approximately 80,000 opioid overdose deaths annually.5 Brixadi offers US patients and healthcare professionals a new and effective treatment option for opioid use disorder, with both weekly and monthly dosing to meet patient's individual treatment needs," says Dr. Fredrik Tiberg, President & CEO of Camurus. "Based on the success of Buvidal in Europe, Australia and other territories, we see a significant opportunity for Brixadi in the US," he continues. The FDA approval of Brixadi was based on an extensive clinical program with a randomized, active-controlled Phase 3 trial of CAM2038 against standard treatment with daily sublingual buprenorphine/naloxone (SL BPN).6 The pivotal trial met the primary endpoint of non-inferiority for responder rate (p 6-8 and blockade of opioid drug liking.8 The safety profile of Brixadi was consistent with the known safety profile of SL BPN except for mild to moderate injection site reactions.1,6,7 Brixadi is formulated using Camurus' FluidCrystal® injection depot technology. The product is administered subcutaneously by a healthcare professional as a small volume injection (0.16-0.64 mL) in the buttock, thigh, stomach, or upper arm. Brixadi does not require refrigeration. Fredrik Tiberg, President & CEO
Fredrik Joabsson, Chief Business Development Officer
*Payable on first commercial sale of the products in the US but not later than 3 months after NDA approval.
Brixadi (buprenorphine) extended-release injection for subcutaneous use is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. Brixadi should be used as part of a complete treatment plan that includes counselling and psychosocial support. The product is available through a restricted distribution program known as the Brixadi REMS Program and is only administered by healthcare professionals. Brixadi is the US trademark for Camurus' product Buvidal, which is approved for treatment of opioid dependence in the EU, UK, Switzerland, Australia, New Zealand and several countries in the Middle East and North Africa. Camurus is a Swedish, science-led biopharmaceutical company committed to developing and commercializing innovative, long-acting medicines for the treatment of severe and chronic conditions. New drug products with best-in-class potential are conceived based on the company's proprietary FluidCrystal® drug delivery technologies and its extensive R&D expertise. Camurus' clinical pipeline includes products for the treatment of cancer, endocrine diseases, pain and addiction, which are developed in-house and in collaboration with international pharmaceutical companies. The company's shares are listed on Nasdaq Stockholm under the ticker CAMX. For more information, visit www.camurus.com. Keyes KM, et al. Drug Alc. Dep. Reports 2022.
CDC, Opioid Use Disorder: https://www.cdc.gov/dotw/opioid-use-disorder
CDC, Provisional Drug Overdose Death Counts: www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm
Frost M., et al. Long-term safety of a weekly and monthly subcutaneous buprenorphine depot (CAM2038) in the treatment of adult out-patients with opioid use disorder. Addiction. 2019; 114(8):1416-1426. This information is information that Camurus AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the managing director, at 08:30 pm CET on 23 May 2023. The following files are available for download: