Buvidal® (buprenorphine) prolonged release injection receives reimbursement in Sweden from the 15 May 2020 after approval by TLV1
LUND, Sweden, May 14, 2020 /PRNewswire/ -- Following a decision by the Dental and Pharmaceutical Benefits Agency, TLV, Buvidal® (buprenorphine) prolonged release injection has received reimbursement in Sweden for treatment of opioid dependence.1 Buvidal is approved for use in adults and adolescents over 16 years who are also receiving medical, social and psychological support.2-3
"The decision by TLV means that patients in Sweden will have access to a fully reimbursed, long-acting treatment option with the potential of improved treatment outcomes and quality of life for patients with opioid dependence", says Mikael Sandell, MD Consultant, Head of LARO treatment, PRIMA Maria, Stockholm. "By decreasing need for frequent, often supervised administration, Buvidal reduces the burden on patients and healthcare providers which over time can free up resources and contribute to a better access to treatment".
"We are pleased with the results of TLV's analysis showing that Buvidal is cost saving - even when excluding clinically demonstrated benefits of superior efficacy, patient satisfaction, improved quality of life and reduced treatment burden and stigma, says Fredrik Tiberg, PhD, President & CEO of Camurus. "As Buvidal must be administered by a healthcare professional, the risks of diversion and misuse are minimized."
Buvidal is a long-acting buprenorphine medication given as a subcutaneous injection once a week or once a month. Buvidal has in clinical studies proven effective in reducing illicit opioid use, alleviating opioid withdrawal and cravings and achieve opioid blockade.3-4
Opioid dependence is a serious, chronic, relapsing disease associated with significant adverse mental, physical, and social consequences, including unemployment, criminal activity, incarceration, transmission of infectious diseases, unintentional overdose and death. Standard of care is pharmacological treatment in combination with psychosocial counselling.
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 is currently launched in seven countries in the EU and Australia.
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.
- The Swedish Dental and Pharmaceutical Benefits Agency, TLV. Decision on Buvidal, 14. May 2020. www.tlv.se
- Buvidal (buprenorfin injektionsvätska, depålösning). Summary of product characteristics, www.fass.se
- Buvidal EPAR, https://www.ema.europa.eu/en/medicines/human/EPAR/buvidal
- 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.
- 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
For more information
Fredrik Tiberg, President & CEO
Fredrik Joabsson, Chief Business Development Officer
The information was submitted for publication at 5:00 pm CET on 14 May 2020.
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SOURCE Camurus AB