Generic Rotigotine Transdermal Patch Ready for Trial, XPhyto Says
Skin study shows absorption similar to Neupro at optimized formula
XPhyto Therapeutics’ generic version of the Neupro patch for Parkinson’s disease is showing that its active ingredient, rotigotine, can be absorbed through the skin in ways similar to the brand-name product, the company announced.
Findings, in work using skin from human cadavers and an optimized formula for the generic patch, support clinical testing of these transdermal patches, the company stated.
“We are confident that our Rotigotine patch is fully optimized and ready for further human clinical evaluation,” Rogers added.
Generic rotigotine transdermal patch could lower treatment’s cost
UCB’s Neupro patches are approved in the U.S. and Europe for the daily treatment of Parkinson’s and restless leg syndrome.
These transdermal patches contain rotigotine, a molecule that mimics the action of dopamine in the brain. Dopamine is the neurochemical that’s progressively depleted in Parkinson’s.
When placed on the skin, the Neupro patch slowly and steadily releases rotigotine over a 24-hour period. The medication is absorbed through the skin, working to supplement dopamine’s effects and ease Parkinson’s symptoms.
Vector Pharma, an XPhyto subsidiary, developed a generic version in 2020. As a generic, these patches aim to be equally safe and effective as the brand-name version, but they are expected to be available at lower cost.
To be approved for commercial use, however, laboratory and in-human studies first must demonstrate this bioequivalence.
A bioavailability pilot study comparing the generic and Neupro patches, conducted in Europe over about two weeks, successfully evaluated how much rotigotine moved into the body and was able to have an active effect, the company announced in May.
Work to optimize the patches’ formulation was also undertaken.
Earlier this month, XPhyto announced that after several rounds of studies in mouse and human cadaver skin samples, the company had finalized the formulation it would use.
In the most recent preclinical study, the optimized formula was released from the patch and absorbed into three human cadaver skin samples over a 24-hour period, and compared with Neupro.
“Study results demonstrate exceptionally similar dissolution and absorption profiles between XPhyto’s drug formulation and the name brand product,” the company stated in its release.