Swissmedic approves Buvidal for the treatment of opioid dependence


LUND, Sweden, Dec. 18, 2020 /PRNewswire/ — Camurus AB (NASDAQ STO: CAMX) introduced right this moment that the Swiss company for therapeutic merchandise, Swissmedic, has accredited weekly and month-to-month Buvidal® extended launch buprenorphine for the therapy of opioid dependence in adults and adolescents from 16 years of age. This marks the primary approval of a long-acting therapy for opioid dependence in Switzerland.

“We’re happy with the expeditious assessment and approval of our market authorization software for Buvidal by Swissmedic and that sufferers with opioid dependence in Switzerland will now have entry to an efficient long-acting therapy,” says Fredrik Tiberg, PhD, President & CEO of Camurus.

There are at the moment an estimated 20,000 sufferers receiving pharmacological therapy for opioid dependence in Switzerland, of which a majority are on day by day opioid agonist therapy.1

Buvidal is a long-acting buprenorphine treatment given as a subcutaneous injection as soon as every week or as soon as a month. In medical research, the therapy has confirmed to be efficient in decreasing illicit opioid use, assuaging opioid withdrawal and cravings, attaining opioid blockade, and bettering affected person reported experiences and outcomes in contrast with day by day sublingual medicines.2-5

Opioid dependence is a critical, persistent, relapsing illness related to a disproportionate quantity of drug-related hurt that features infectious ailments and different well being issues, mortality, unemployment, homelessness and social exclusion6.

For extra info
Fredrik Tiberg, President & CEO
Tel. +46 (0)46 286 46 92
[email protected] 

Fredrik Joabsson, Chief Enterprise Improvement Officer
Tel. +46 (0)70 776 17 37
[email protected]

About Buvidal

Buvidal (buprenorphine prolonged-release answer for subcutaneous injection in prefilled syringe) is indicated for the therapy of opioid dependence inside a framework of medical, social and psychological therapy. Therapy is meant to be used in adults and adolescents aged 16 years or over. Buvidal is designed for versatile dosing and is on the market in 4 weekly strengths (8 mg, 16 mg, 24 mg and 32 mg) and three month-to-month strengths (64 mg, 96 mg and 128 mg), enabling therapy to be tailor-made to the affected person’s particular person wants. Administration of Buvidal is restricted to healthcare professionals, rising therapy compliance, and minimizing dangers of diversion, misuse and pediatric publicity.

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

About Camurus

Camurus is a Swedish, science-led biopharmaceutical firm dedicated to creating and commercializing progressive, long-acting medicines for the therapy of extreme and persistent situations. New drug merchandise with best-in-class potential are conceived primarily based on the corporate’s proprietary FluidCrystal® drug supply applied sciences and its intensive R&D experience. Camurus’ medical pipeline contains merchandise for the therapy of most cancers, endocrine ailments, ache and habit, that are developed in-house and in collaboration with worldwide pharmaceutical firms. The corporate’s shares are listed on Nasdaq Stockholm beneath the ticker CAMX. For extra info, go to camurus.com.

Reference : 

  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 month-to-month subcutaneous buprenorphine depot formulations vs day by day sublingual buprenorphine with naloxone for therapy of opioid use dysfunction: A randomized medical trial. JAMA Intern Med. 2018; 178(6):764-773.
  3. Frost M, Bailey GL, Lintzeris N, et al. Lengthytime period security of a weekly and month-to-month subcutaneous buprenorphine depot (CAM2038) within the therapy of grownup outsufferers with opioid use dysfunction. Dependancy. 2019; 114(8):1416-1426
  4. Walsh SL, Comer SD, Lofwall MR, et al. Impact of Buprenorphine Weekly Depot (CAM2038) and Hydromorphone Blockade in People with Opioid Use Dysfunction: A Randomized Medical Trial. JAMA Psychiatry. 2017; 74(9): 894-902
  5. Lintzeris N, Dunlop A, Haber P, et al. Outcomes of the DEBUT Research – A Multisite, Open-Label RCT of Weekly and Month-to-month Depot Buprenorphine Injections (CAM2038) Vs. Day by day Sublingual Remedy Investigating Affected person Reported Outcomes in Therapy of Opioid Use Dysfunction. Introduced at The School on Issues of Drug Dependence, (CPDD) Digital Assembly June 22-24, 2020
  6. https://www.emcdda.europa.eu/best-practice/briefings/tackling-opioid-dependence_en 

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

This info was dropped at you by Cision http://news.cision.com

https://news.cision.com/camurus-ab/r/swissmedic-approves-buvidal-for-the-treatment-of-opioid-dependence,c3257661

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