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

Nov 22 - A caregiver's story: Living and loving through the slow process of dying
Nov 19 - Testosterone cause of sex differences in the occurrence of Parkinson’s disease, new research suggests
Nov 18 - New strategy reduces side effects in Parkinson's treatment
Nov 14 - Opinion: The never-ending tests of Parkinson's disease
Nov 13 - Parkinson’s disease: A new tool for diagnosis
Nov 10 - Parkinson's Disease Drug May Be Useful For Delaying, Preventing Blindness In Older Population
Nov 9 - Microsoft VP’s diagnosis fuels employees’ heartfelt efforts to help others
Nov 6 - Lewy body dementia: unrecognized and misdiagnosed
Nov 5 - Gait difficulties in Parkinson's linked to new blood vessels in brain
Oct 30 - Special Section: Enabling Technologies for Parkinson’s Disease Management
Oct 27 - Scientists discover a 'switchboard' of molecules that protect against Parkinson's disease
Oct 26 - Dancing improves mobility and quality of life in people with Parkinson's
Oct 23 - The amazing woman who can smell Parkinson’s disease — before symptoms appear
Oct 20 - Personal Essay: The deviousness of dementia
Oct 19 - Mechanism that 'melts' protein clumps may lead to new Parkinson's treatments
Oct 19 - Researchers find that stem cell treatment may reduce cognitive impairment related to dementia with Lewy bodies
Oct 17 - Cancer Drug Helps Parkinson's Patients
Oct 12 - Researchers identify immune gene that can prevent Parkinson's disease and dementia
Oct 12 - Blog Post: An Alert, Well-Hydrated Artist in No Acute Distress
Oct 7 - This month, a brain surgery will be broadcast on live TV for the first time ever