BioNxt Solutions Inc. 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 begin in four to six weeks.
 
The Company previously received government approval for its planned human bioavailability study to be carried out by a qualified European contract research organization. The comparative study is designed to assess the relative bioavailability, skin adhesion and skin tolerance of BioNxt’s new formulation compared to the name brand product. 
 
The 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 based on the TDS platform technology developed by BioNxt’s wholly owned subsidiary, Vektor Pharma TF GmbH, a German drug development and manufacturing company.
 
Rotigotine is a non-ergoline dopamine agonist approved for the treatment of Parkinson’s disease and restless legs syndrome (RLS) in Europe and the U.S. 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. 
 
According to Wissen Market Research, total global sales for Rotigotine patches were approximately $518 million in 2021 with the market expected to surpass $766 million by 2030.
 
BioNxt’s Rotigotine transdermal patch is based on its own platform technology which represents a scalable opportunity for additional TDS drug development and manufacturing programs. According to Research and Markets, the global transdermal skin patch market had a value of nearly $6.5 billion in 2020 while Kuick Research, Pharmaceutical and Healthcare, estimates the market will reach approximately $20 billion by 2028.