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

Oct 18 - Brain disconnections may contribute to Parkinson's hallucinations
Oct 18 - Fighting Parkinson's disease through dance
Oct 17 - Scientists Identify Structure of PINK1, Key Parkinson’s-protective Protein
Oct 17 - Diabetes drug cuts Parkinson's risk by 28 percent, study finds
Oct 10 - Advances in Brain Pacemaker Reduces Tremors, Helps Parkinson's Sufferers Live a More Normal Life
Oct 10 - Medical History Could Help Predict Parkinson's Disease Risk Long Before Diagnosis
Oct 3 - Changes in Olfactory Bulb Explain Loss of Smell in Early Stages of Parkinson’s Disease, Study Finds
Oct 3 - Sleep Disturbances May Worsen Motor Symptoms in Parkinson’s Disease, Study Suggests
Sep 12 - Australian Researchers Develop New Diagnostic Tool to Spot Early Signs of Parkinson’s
Sep 11 - GeneFo Webinar to Focus on Using Humor to Manage Parkinson’s Disease
Sep 6 - Parkinson’s and the ‘D’ word
Sep 6 - Compounds in Asthma Drugs Might Be Used as Parkinson’s Treatment
Sep 5 - AstraZeneca Joins Takeda, Berg to Advance Development of Parkinson’s Disease Therapies
Sep 1 - Stem Cell Transplant Trial in Parkinson’s Patients Planned After Test in Japan Succeeds in Monkeys
Sep 1 - Titan to Start Phase 1/2 Study of Subdermal Implant to Deliver Requip to Parkinson’s Patients
Aug 30 - FDA Refuses Acorda’s Inbrija New Drug Application Due to Manufacturing Questions
Aug 23 - Support Groups: Are They for You?
Aug 22 - Internet Visits with Parkinson’s Specialist Can Be as Effective as In-person Visits, Trial Finds
Aug 21 - Cavion’s New CMO to Lead Cav3 Platform Development for Neurological Diseases
Aug 15 - Singing Helps Early-stage Parkinson’s Patients Retain Speech, Respiratory Control, Studies Show