Parkinson's Patch Nears U.S. Approval
Once-a-Day Drug for Parkinson's Disease Safe, Effective in Clinical Trials
Can Parkinson's Patch Outperform Its Peers? continued...
Unfortunately, patients on these drugs may begin to experience the on/off effect as well. It's been thought that this happens because oral medicines can't deliver a steady stream of the drug to the brain.
The Parkinson's patch is designed to solve this problem. It bypasses the digestive system and gives a steady supply of the drug to the brain.
"From a potency standpoint, no, this compound is no more potent than other agonists," Watts says. "But this delivery system is unique. Studies in animals show long-acting delivery over short-acting delivery reduces Parkinson's disease symptoms. This long-acting delivery system will be very important, but the longer-term studies have not yet been done."
Parkinson's expert Curt R. Freed, MD, heads the division of clinical pharmacology and toxicology at the University of Colorado Health Science Center in Denver. In an email interview, Freed says that it's by no means sure that the patch will eliminate the "off" periods seen with L-dopa and oral dopamine agonists.
"The other dopamine agonists have half-lives in the six-hour range, which is nearly as good as continuous administration," Freed tells WebMD. "Patients with advanced Parkinson’s disease may have only two clinical states, immobile 'off' and [involuntary movement] 'on.' Whether rotigotine by patch will change this scenario remains to be seen."
U.S. Approval Expected
Schwarz Pharma Product Director Michael Davis tells WebMD that the FDA has given the Parkinson's patch an "approvable letter." Such letters usually mean that the agency thinks it has enough information to approve the drug.
Davis says the company hopes to hear good news from the FDA in the first half of 2007.
So who will use the drug? Freed says that won't be known until doctors have a chance to see what the drug can do in widespread clinical use.
Watts says that the patch is very likely to be helpful "for an important subset of patients."
"As with any new development and any new treatment for Parkinson's disease, the patch expands the options for patients," Watts says. "This is an important step in the treatment of Parkinson's disease. But there are also many other lines of investigation that will lead to new treatments."