BioNxt Solutions Inc. is thrilled to share an update on its commercialization plan for the transdermal Rotigotine patch, a revolutionary treatment for those living with Parkinson’s disease. The patch, developed by the Company’s German subsidiary Vektor Pharma TF GmbH, is based on the advanced TDS platform technology. With this update, BioNxt is taking a big step towards improving the lives of those with PD.
BioNxt has achieved remarkable results from its ex-vivo and in-vitro tests of its PD treatment, with its new optimized transdermal formulation proving to be more effective than its global name brand counterpart. In preparation for a human clinical pilot study set for the second quarter of 2023, the Company has designed a randomized, crossover, two-period, single dose study to evaluate the relative bioavailability, skin adhesion, and skin tolerance of its formulation compared to the name brand. All tests will be conducted in Europe with adherence to Good Clinical Practice (GCP) and the European Medical Agency (EMA) Guidelines for quality transdermal patches.
BioNxt is taking the necessary steps to commercialize its products, starting with the development of manufacturing capabilities at its German drug development facility. The facility is equipped with EU GMP-approved manufacturing and packaging equipment, as well as a modified manufacturing line capable of producing pivotal trial materials compliant with commercial regulatory approval applications and final commercial products. In the near future, BioNxt will be making more announcements regarding its commercialization progress, so stay tuned!
BioNxt’s Rotigotine transdermal product is a revolutionary breakthrough in drug development and manufacturing. Boasting a 100% owned platform technology, this single product is the gateway to an expansive opportunity in the transdermal skin patch market. A recent report from Research and Markets valued the market at nearly US$6.5 billion in 2020, while Kuick Research, Pharmaceutical and Healthcare, estimates that the market will skyrocket to an impressive US$20 billion by 2028.
Vektor, a subsidiary of BioNxt, is a German-based narcotics manufacturer, developer, and researcher located in the district of Biberach, Baden-Württemberg. For over a decade, the company has been at the forefront of designing, testing and manufacturing innovative, non-invasive drug delivery systems such as transdermal patches and sub-lingual strips to deliver active pharmaceutical ingredients for the treatment of pain and neurological conditions. According to Precedence Research, the global drug delivery market is expected to grow from US$1,476 billion in 2021 to US$2,047 billion by 2030, making Vektor an essential player in the field.
About BioNxt Solutions Inc.
BioNxt Solutions Inc. is a bioscience accelerator dedicated to revolutionizing the way we deliver treatments and diagnose diseases. Our teams in North America and Europe are developing precision transdermal and oral dissolvable drug formulations, rapid and low-cost infectious disease and oral health screening tests, and standardizing and evaluating emerging active pharmaceutical ingredients for neurological applications. We are currently focused on obtaining regulatory approval and commercializing our medical products in Europe, thereby providing the latest treatments and diagnoses to those who need it.