Camurus AB: Camurus announces US launch of Brixadi™ for the treatment of moderate to severe opioid use disorder by Braeburn
Lund, Sweden - 5 September 2023 - Camurus (NASDAQ STO: CAMX) today announces that Brixadi™ (buprenorphine) extended-release injection, a weekly and monthly medication for the treatment of moderate to severe opioid use disorder (OUD), is now available in the US for patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with a daily buprenorphine product. Brixadi should be used as part of a complete treatment plan that includes counseling and psychosocial support.
"We are delighted that Brixadi is now available to people with opioid use disorder in the US. With an estimated six million people with OUD and 80,000 deaths each year related to opioid overdoses, it is critically important to provide people with OUD access to new effective treatment options that can support their long-term recovery," says Dr. Fredrik Tiberg, President & CEO of Camurus. "Based on the strong development for Buvidal in Europe and Australia, we are positive about the prospects for the medication on the US market."
Brixadi is formulated based on Camurus' proprietary FluidCrystal[®] injection depot technology and is marketed in the US by Braeburn under a license agreement with Camurus. Brixadi is the first and only buprenorphine product that offers weekly and monthly doses. Patients currently being treated with oral buprenorphine-containing products can be switched directly to either Brixadi Weekly or Brixadi Monthly in accordance with equivalent doses suggested in the Prescribing Information (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210136Orig1s000lbl.pdf).
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 people; of these approximately 3 million are diagnosed with OUD, with about half receiving medical treatment.[3,4]
For more information
Fredrik Tiberg, President & CEO
Tel. +46 (0)46 286 46 92
Fredrik Joabsson, Chief Business Development Officer
Tel. +46 (0)70 776 17 37
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 administered subcutaneously as a small volume injection (0.16-0.64 mL) in the buttock, thigh, stomach, or upper arm, and does not require refrigeration.
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.
The product rights to Brixadi in North America are licensed to Braeburn by Camurus.
Brixadi was approved by the US Food and Drug Administration (FDA) on 23 May, 2023.
Camurus is a Swedish science-led biopharmaceutical company committed to developing and commercializing innovative and differentiated 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 dependence, pain, cancer, and endocrine disease, 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.
1. Brixadi Prescribing Information (https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210136Orig1s000lbl.pdf)
2. Keyes KM, et al. Drug Alc. Dep. Reports 2022.
3. CDC, Opioid Use Disorder: https://www.cdc.gov/dotw/opioid-use-disorder
4. Symphony Health data
5. Press release 23 May, 2023: Camurus announces FDA approval of Brixadi™ for the treatment of moderate to severe opioid use disorder (https://www.camurus.com/media/press-releases/2023/camurus-announces-fda-approval-of-brixadi-for-the-treatment-of-moderate-to-severe-opioid-use-disorder/)
The information was submitted for publication at 2:00 pm CET on 5 September 2023.