August 25, 2017
By Mark Terry, BioSpace.com Breaking News Staff
Emeryville, Calif. – The U.S. Food and Drug Administration (FDA) approved Adamas Pharmaceuticals’ Gocovri (amantadine) extended release capsules to treat dyskinesia in Parkinson’s disease who are receiving levodopa-based therapy. It is the first and only drug approved by the FDA for this indication.
“Gocovri’s approval is an important advancement for the treatment of Parkinson’s disease, as it is the first FDA-approved medicine for the treatment of dyskinesia in Parkinson’s disease patients,” said Rajesh Pahwa, Laverne & Joyce Rider Professor of Neurology at the Kansas Medical Center and director, Parkinson’s Disease Center of Excellence at the University of Kansas Health System, in a statement. “Notably, Gocovri is the first Parkinson’s disease medicine proven in controlled trials to reduce both dyskinesia and OFF time in Parkinson’s disease patients receiving levodopa. Treatment of dyskinesia and OFF time continues to be an unmet need in the medical management of Parkinson’s disease and the approval of Gocovri is a major step in that direction.”
The company indicates it expects the drug to be available in the fourth quarter of this year, with a formal launch of its full sales force in January 2018. Adamas Pharmaceuticals has developed its “Gocovri Onboard” patient services program to aid in access and distribution of the drug, as well as financial assistance.
Not surprisingly, took a jump at the news, currently trading at $20.25. On August 24, shares traded for $14.25.
Seeking Alpha notes, “The truth is that the gains for Adamas are just beginning. The stock traded higher by 36 percent in after-hours as soon as the results were released. There is more value to be created, because this is a first for the Parkinson’s disease community. That’s because prior to Gocovri approval, there were no FDA approved products to treat dyskinesia in Parkinson’s patients. This FDA approval secures for Adamas the ability to market the drug with zero competition in place.”
The drug approval was based on two Phase III clinical trials. In the first trial, patients receiving the drug showed a statistically significant cut in dyskinesia over a 12-week treatment period. The second trial also had positive results, showing a 46 percent decrease on the Unified Dyskinesia Rating Scale compared to placebo, which had a 16 percent reduction. It also hit its secondary endpoint in both trials, which was the measurement of an increase in functional time daily.
In the U.S., there are approximately 200,000 Parkinson’s disease patients with dyskinesia. About 1 million patients in the U.S. develop Parkinson’s disease. Levodopa is the most common therapy, and patients that stay on the therapy for at least 10 years may develop dyskinesia.
The company is also planning to evaluate the drug in patients with multiple sclerosis (MS) that have problems walking. That’s a larger market than the Parkinson’s dyskinesia, with about 2 million people worldwide and 400,000 in the U.S. with MS, and about 80 percent of them have difficulties walking.
“Today’s approval is a tremendous milestone for Adamas and for the Parkinson’s disease community,” said Gregory Went, founder, chairman and chief executive officer of Adams Pharmaceuticals, in a statement. “Gocovri has the potential to help people with Parkinson’s disease suffering from dyskinesia by finally providing physicians with an effective tool to address this long-standing unmet medical need. We thank the physicians, clinical staff, patients and their families who participated in the clinical trials for making this advancement possible for the community.”
