Swissmedic approves Buvidal for the treatment of opioid dependence

Lund, Sweden — 18 December 2020 — Camurus AB (NASDAQ STO: CAMX) announced today that the Swiss agency for therapeutic products, Swissmedic, has approved weekly and monthly Buvidal^® prolonged release buprenorphine for the treatment of opioid dependence in adults and adolescents from 16 years of age. This marks the first approval of a long-acting treatment for opioid dependence in Switzerland.

“We are pleased with the expeditious review and approval of our market authorization application for Buvidal by Swissmedic and that patients with opioid dependence in Switzerland will now have access to an effective long-acting treatment,” says Fredrik Tiberg, PhD, President & CEO of Camurus.

There are currently an estimated 20,000 patients receiving pharmacological treatment for opioid dependence in Switzerland, of which a majority are on daily opioid agonist treatment.¹

Buvidal is a long-acting buprenorphine medication given as a subcutaneous injection once a week or once a month. In clinical studies, the treatment has proven to be effective in reducing illicit opioid use, alleviating opioid withdrawal and cravings, achieving opioid blockade, and improving patient reported experiences and outcomes compared with daily sublingual medications.^2-5

Opioid dependence is a serious, chronic, relapsing disease associated with a disproportionate amount of drug-related harm that includes infectious diseases and other health problems, mortality, unemployment, homelessness and social exclusion⁶.

For more information
Fredrik Tiberg, President & CEO
Tel. +46 (0)46 286 46 92
fredrik.tiberg@camurus.com

Fredrik Joabsson, Chief Business Development Officer
Tel. +46 (0)70 776 17 37
ir@camurus.com

About Buvidal
Buvidal (buprenorphine prolonged-release solution for subcutaneous injection in prefilled syringe) is indicated for the treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over. Buvidal is designed for flexible dosing and is available in four weekly strengths (8 mg, 16 mg, 24 mg and 32 mg) and three monthly strengths (64 mg, 96 mg and 128 mg), enabling treatment to be tailored to the patient’s individual needs. Administration of Buvidal is restricted to healthcare professionals, increasing treatment compliance, and minimizing risks of diversion, misuse and pediatric exposure.

Buvidal received market authorizations in EU and Australia in November 2018.  

About Camurus
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 camurus.com.

References

1. https://www.bag.admin.ch/bag/de/home/gesund-leben/sucht-und-gesundheit/suchtberatung-therapie/substitutionsgestuetzte-behandlung.html
2. Lofwall MR, Walsh SL, Nunes EV, et al. Weekly and monthly subcutaneous buprenorphine depot formulations vs daily sublingual buprenorphine with naloxone for treatment of opioid use disorder: A randomized clinical trial. JAMA Intern Med. 2018; 178(6):764-773.
3. Frost M, Bailey GL, Lintzeris N, 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
4. Walsh SL, Comer SD, Lofwall MR, et al. Effect of Buprenorphine Weekly Depot (CAM2038) and Hydromorphone Blockade in Individuals with Opioid Use Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2017; 74(9): 894-902
5. Lintzeris N, Dunlop A, Haber P, et al. Results of the DEBUT Study – A Multisite, Open-Label RCT of Weekly and Monthly Depot Buprenorphine Injections (CAM2038) Vs. Daily Sublingual Therapy Investigating Patient Reported Outcomes in Treatment of Opioid Use Disorder. Presented at The College on Problems of Drug Dependence, (CPDD) Virtual Meeting June 22-24, 2020
6. https://www.emcdda.europa.eu/best-practice/briefings/tackling-opioid-dependence_en

The information was submitted for publication at 8:00 am CET on 18 December 2020.