BioNxt Solutions Inc. will initiate its comparative drug absorption study for the company’s transdermal (TDS) Rotigotine patch for the treatment of Parkinson’s disease.

The company has also commenced the manufacture of clinical samples for use in the study which is planned for early Q2 2023.

In addition, BioNxt has finalized its plans for the 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.

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 also commenced the manufacture of transdermal clinical samples based on the TDS platform technology developed by its wholly owned German subsidiary, Vektor Pharma TF GmbH (“Vektor”).

Meanwhile, BioNxt said that it is working to develop in-house commercial manufacturing capabilities at its German drug development facility. This will include EU GMP-approved manufacturing and packaging equipment as well as a certified manufacturing line capable of producing pivotal trial materials compliant with commercial regulatory approval applications and final commercial products (transdermal and oral dissolvable).

The company said that it expects to make further announcements regarding its commercialization capabilities over the coming months.