Pharma Focus Asia

Bionxt Signs Agreement for Study of Transdermal Rotigotine Patch

Wednesday, March 01, 2023

BioNxt Solutions announced agreement to carry out its comparative drug absorption study for the Company’s transdermal (“TDS”) Rotigotine patch for the treatment of Parkinson’s disease.

The comparative study is designed as a randomised, 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 Practise (GCP) and the European Medical Agency (EMA) Guideline on quality of transdermal patches.

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.

BioNxt’s Rotigotine transdermal patch is one product based on its 100% owned platform technology which represents a scalable opportunity for additional TDS drug development and manufacturing programmes.

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