The company has completed manufacturing of all transdermal clinical samples used in the study based on TDS platform technology developed by the German subsidiary of BioNXT.
BioNxt Solutions Inc. (“BioNxt” or the “Company”) (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT) is pleased to report that it has received government approval for the Company to proceed with its comparative drug absorption study approval has been received. Rotigotine transdermal patch (“TDS”) for the treatment of Parkinson’s disease. The study is expected to begin in four to six weeks.
In addition to BioNxt’s February 13 and March 1, 2023 press releases, the company has received government approval for its planned human bioavailability study to be conducted by a qualified European contract research organization. The comparative study is designed as a single-dose, two-period, randomized, crossover pilot study to assess the relative bioavailability, skin adhesion and skin tolerability of the new formulation of BioNxt compared to the brand-name product. Study results are expected four to six weeks after completion.
Human studies will be conducted in Europe in accordance with Good Clinical Practice (GCP) and European Medical Agency (EMA) guidelines on the quality of transdermal patches. The company has completed manufacturing of all transdermal clinical samples used in the study based on TDS platform technology developed by the German subsidiary of BioNXT.
Rotigotine is a non-ergoline dopamine agonist approved in Europe and the United States for the treatment of Parkinson’s disease and restless legs syndrome (RLS). The active pharmaceutical ingredient is not well absorbed orally and is formulated as a once-daily TDS patch to increase bioavailability and provide controlled and continuous delivery of the drug over the course of 24 hours. The Parkinson’s disease therapeutic market exceeds 10 million people worldwide and continues to grow. The best-selling branded product launched by the originator in 2007, independently set to sell over $375 million of its rotigotine TDS patches in 2021. According to Visen Market Research, total worldwide sales of rotigotine patches were approximately $518 million. expected to exceed $766 million in 2030.
BioNxt’s rotigotine transdermal patch is a product based on its 100% proprietary platform technology that represents a scalable opportunity for additional TDS drug development and manufacturing programs. According to Research & Markets, the global market for transdermal skin patches was estimated to be approximately $6.5 billion in 2020, while Kuik Research, Pharmaceutical & Healthcare estimates the market will reach approximately $20 billion by 2028.
Vektor Pharma TF GmbH is a wholly owned subsidiary of BioNxt, a German narcotics licensed pharmaceutical development and manufacturing company based in Biberach district, Baden-Württemberg, Germany. For more than a decade, the company and its team have been pioneers in the design, testing and manufacturing of innovative and non-invasive drug delivery systems, notably transdermal patches and sublingual strips for the administration of active pharmaceutical ingredients for the treatment of pain . and neurological conditions.
BioNxt Solutions Inc. About this
BioNxt Solutions Inc. is a biosciences accelerator focused on the production and evaluation of next-generation drug delivery systems and formulations, clinical investigation trials, and new active pharmaceutical ingredients.
