Zim Lab And Neuraxpharm Announces Grant Of Marketing Authorization For Buprenorphine Sublingual Film In Europe

11-Jan-25   09:56 Hrs IST
ZIM Laboratories and Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders announced that Committee for Medicinal Products for Human Use (CHMP) has granted Marketing Authorization (MA) to Neuraxpharm, for Buprenorphine Sublingual Film in Europe, co 'developed by ZIM LABS using its patented oral thin-film technology.

Buprenorphine is indicated for the substitution treatment of opioid drug dependence. According to IQVIA, the European market for Buprenorphine-based opioid dependency treatments in 2023 surpassed USD 355 million annually, driven by increasing awareness and improved access to treatment programs. Further, the market size for Buprenorphine reached USD 1.3 billion in 2023.

Developed using ZIM LABS' proprietary oral thin-film technology, the sublingual film offers rapid dissolution under the tongue for faster therapeutic action and improved patient compliance. This advanced formulation minimizes risks associated with misuse, respiratory depression, and overdose, setting a new benchmark in patient safety. Buprenorphine Sublingual Film follows the co-development agreement in Europe of novel oral thin films (OTF) between ZIM LABS and Neuraxpharm announced in 2019.

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