BioNxt Solutions signs clinical study agreement and commences clinical samples manufacture for Parkinson’s disease trial

pharmafile | March 1, 2023 | News story | Research and Development  

BioNxt Solutions, a bioscience accelerator focused on next-generation drug formulations and delivery systems, has announced the finalisation of its comparative drug absorption study and the commencement of clinical supply manufacturing.


The study is into BioNxt’s transdermal (TDS) Rotigotine patch for the treatment of Parkinson’s disease. It is designed as a randomised, crossover, two-period single-dose pilot study which will assess the relative bioavailability, skin adhesion and skin tolerance of BioNxt’s new formulation, compared to the name brand product.


Rotigotine is a non-ergoline dopamine agonist approved for the treatment of Parkinson’s disease and restless leg syndrome (RLS) in Europe and the US. It is not absorbed well orally, which is why the company is looking to TDS patches which will provide a controlled and steady dosage over 24 hours.


It is working on bringing its commercial manufacturing in-house, which will include EU GMP-approved manufacturing and packaging equipment as well as a certified manufacturing line capable of producing trial materials. The patches used in the study will be based on TDS platform technology developed by its subsidiary Vektor Pharma.


James Spargo

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