BioNxt Solutions Inc. reported that it has received government approval for to proceed with its comparative drug absorption study for the Company's transdermal ("TDS") Rotigotine patch for the treatment of Parkinson's disease. The study is expected to commence in four to six weeks. Further to BioNxt's press releases dated February 13 and March 1, 2023, the Company has received governmental approval for planned human bioavailability study to be carried out by a qualified European contract research organization.

The comparative study is designed as a randomized, crossover, two-period, single dose pilot study to assess the relative bioavailability, skin adhesion and skin tolerance of BioNxt's new formulation compared to the name brand product. Results from the study are expected four to six weeks after completion. The human study will be carried out in Europe in accordance with Good Clinical Practice (GCP) and the European Medical Agency (EMA) Guideline on quality of transdermal patches.

The Company has completed the manufacture of all transdermal clinical samples to be used in the study based on the TDS platform technology developed by BioNxt's wholly owned German subsidiary. Rotigotine is a non-ergoline dopamine agonist approved for the treatment of Parkinson's Disease and restless legs syndrome (RLS) in Europe and the United States. The active pharmaceutical ingredient is not well absorbed via oral delivery and is formulated as a once-daily TDS patch to increase bioavailability and provide a controlled and steady supply of the drug over the course of 24 hours.

The therapeutic market for Parkinson's disease is over 10 million people worldwide and growing. The top selling name brand product launched by the originator in 2007 independently sold over USD375 million of its Rotigotine TDS patches in 2021. According to Wissen Market Research, total global sales for Rotigotine patches were approximately USD 5 million in 2021 with the market expected to surpass USD 766 million by 2030.