XPhyto Therapeutics Corp has updated on the progress of its Rotigotine transdermal (TDS) patch product candidate, which is approved to treat Parkinson's disease (PD) and restless legs syndrome (RLS) in Europe and the US, and which is heading towards a final pivotal study in the fourth quarter this year.
The patch is based on the technology of the group's German subsidiary Vektor Pharma. Its active pharmaceutical ingredient is not well absorbed when swallowed so has been formulated as a once-daily patch to increase bioavailability and provide a steady supply of the drug over 24 hours.
In May last year, bioscience firm XPhyto announced the successful completion of a two-week European-based human bioavailability study for the product.
"Based on the results of this study, the company is advancing the product toward a final pivotal study in Q4 2022 and pending positive results of that study, to an application for regulatory approval," XPhyto told investors in a statement.
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In the meantime, the company has completed a human cadaver skin permeation study at Vektor's EU GMP laboratory and manufacturing facility in Germany, to compare Rotigotine absorption between two additional derivative formulas and the name brand product with results expected to be finalized and published in coming weeks.
XPhyto's Rotigotine product is a single product based on Vektor's platform technology which represents a scalable opportunity for additional transdermal drug development and manufacturing programs, noted the firm.
According to Research and Markets, the global transdermal skin patch market had a value of nearly US$6.5 billion in 2020 while Kuick Research, Pharmaceutical and Healthcare, estimates the market will reach around US$20 billion by 2028.
The R&D market for new formulations is competitive; however, there appears to be little success beyond the name brand product launched by the originator in 2007.
According to Wissen Market Research, global sales for Rotigotine patches were around US$518 million in 2021 with the market expected to surpass US$766 million by 2030.
Contact the author at giles@proactiveinvestors.com