NWPF

News ArchivesRead News

Parkinson's extended-release drug fails to win FDA approval for U.S.

Tuesday January 22, 2013

www.nj.com - Impax Laboratories failed to win U.S. approval for a new version of an extended-release drug used to relieve spasms in patients with Parkinson’s disease.

The Food and Drug Administration requires a re-inspection of a plant involved in the development of the medicine called Rytary, which combines standard Parkinson’s medications in a new sustained release formulation, the Hayward, California-based company said today in a statement. A warning letter was issued in May 2011, Impax said.

“We will work with the FDA on the appropriate next steps for the Rytary application,” said Larry Hsu, president and CEO of Impax, in the statement. “We remain committed to resolving the warning letter and bringing this new treatment option to patients who are suffering from Parkinson’s disease.”

The medication would likely be used most among patients for whom the standard medicines, levodopa and carbidopa, have stopped working as reliably, said David Amsellem, an analyst with Piper Jaffray & Co. in New York. Rytary could generate peak sales of $200 million to $300 million, Amsellem said.

“A controlled-release product is something that has been elusive over the years,” Amsellem said in a telephone interview.

Impax, which specializes in controlled-release drugs, will develop and sell Rytary in the U.S. and Taiwan while GlaxoSmithKline, based in London, will market it in other regions throughout the world. Impax already markets a generic version of a longer-acting combination called Sinemet, sold by Merck & Co.

Merck’s Sinemet extended-release carbidopa-levodopa tablet received approval in 1991 though it’s not widely used, Amsellem said. People who use it are more likely to suffer impairment of voluntary movement than those who use the immediate-release version, according to the label for the medication.

Involuntary Movements

Patients with advanced Parkinson’s disease who used Rytary experienced a 34 percent decrease in the amount of time during waking hours when the medication wore off and involuntary muscle movements returned, the companies said in an August 2011 statement. This was compared with a decrease of 10 percent for those who used the immediate-release generic drugs combined with entacapone, a medicine that helps more of the other treatments reach the brain.

The starting point was 5.9 hours, improving to 3.8 hours of “off time” when Rytary wore off compared with 5.2 hours for the generics.

Parkinson’s is a progressive neurological disorder that causes body tremors, the loss of muscle control and impaired movement, according to the National Institutes of Health. There is no cure. A variety of medicines provide relief from symptoms for the estimated 10 million people worldwide with the disease.

Recent News

Aug 24 - Study Details Process Involved in Parkinson’s Disease
Aug 20 - Two proteins work together to help cells eliminate trash; Parkinson's may result
Aug 17 - Scientists visualize critical part of basal ganglia pathways
Aug 17 - VA benefits office seeks all vets exposed to Agent Orange
Aug 12 - New, rapid dementia screening tool rivals 'gold standard' clinical evaluations
Aug 11 - Strolling in Seaside, fighting Parkinson's
Aug 11 - Scientists probing molecular origins of Parkinson's disease highlight two proteins
Aug 11 - Could Chocolate Help To Ease Parkinson’s Disease?
Aug 10 - Take 2: Why Seattle should try to replicate Spokane’s 3-on-3 Hoopfest success
Aug 10 - Book Review: A voyage into Parkinson’s disease, led by patient and journalist
Aug 10 - Parkinson's could be slowed with existing drug
Aug 7 - Opinion: Why modern life is making dementia in your 40s more likely
Aug 3 - Software Turns Smartphones into Tools for Medical Research
Jul 31 - Innovative Technology Using Dragonflies Might Offer Insights Into Human Brain Function
Jul 27 - Low-dose lithium reduces side effects from most common treatment for Parkinson's disease
Jul 27 - Opinion: Parkinson's disease creating class of workers who fear for their jobs: PennLive letters
Jul 22 - Parkinson's: Diabetes drug may offer clue to treatment
Jul 19 - Alzheimer's Drugs in the Works Might Treat Other Diseases, Too
Jul 17 - Parkinson's disease may be treatable with antimalaria drugs
Jul 16 - Virtual research studies feasible