Generic Version of Neupro Patch Soon to Enter Testing

Manufacturing will soon begin on a generic version of the Neupro patch, a transdermal delivery system for rotigotine — a dopamine agonist — to treat Parkinson’s symptoms, Vektor Pharma announced in a press release.

Testing of its rotigotine patches will first take place at Vektor’s laboratories in Germany, before quickly moving into bioavailability studies in people at sites in Europe. Results are expected by year’s end, the company reported.

Vektor’s formulation of rotigotine is as a generic and second-generation compound that, like the Neupro patch, works as a dopamine agonist, meaning that it mimics the effects of dopamine. It stimulates dopamine receptors in the brain, making up for the lower levels of this neurotransmitter found in the brains of patients.

Neupro patches, developed by UCB, are used to deliver via absorption through the skin a slow and steady supply of rotigotine over 24 hours. These patches are approved as a daily treatment for symptoms of Parkinson’s disease and restless legs syndrome in Europe and the United States.

Evidence supports this syndrome, marked by continuous discomfort in the legs and the urge to move them while at rest, being due to problems in the basal ganglia, the brain region that controls movement and is dependent on dopamine. Restless leg syndrome is known to affect some Parkinson’s patients.

Vektor, a subsidiary of XPhyto Therapeutics, developed its generic patches earlier this year, but clinical trials couldn’t begin without the manufacturing processes being first put into place.

“Incorporating rotigotine into Vektor’s novel transdermal drug delivery system platform is a major accomplishment. With the formula locked and manufacturing soon to commence, we look forward to the upcoming clinical studies,” said Hugh Rogers, XPhyto’s CEO, in the company’s release.

The studies will test the compound’s bioavailability, or the extent and rate at which a medication’s active substance becomes available in the body.

The company intends to provide periodic updates to their rotigotine drug delivery program as it proceeds.

As a generic medication, the patches are designed to work in the same way and provide the same benefits as name-brand versions, with the same safety profile. They typically become available after patents and exclusivities that protect the branded version end, and generally at lower cost than branded versions.

“Our goal is the commercialization of a low-cost rotigotine patch with superior bioavailability and adhesion properties,” Rogers said.