Adamas Pharmaceuticals, Inc. (NASDAQ:ADMS) skyrocketed 41% in midday trading on Friday after the Food and Drug Administration approved its Parkinson’s drug, Gocovri.
Gocovri has been approved to treat involuntary movements, called dyskinesia. This disorder is common with Parkinson’s patients when they’re on levodopa-based therapy, which is the standard treatment. Gocovri is the first of its kind to be approved by the FDA.
The approved dosage for the drug is 274 mg taken each night to allow the drug to work throughout the day when dyskinesia occurs.
The FDA approved the drug based on positive data from two Phase 3 studies. In the first study, treatment with Gocovri led to a reduction in the Unified Dyskinesia Rating Scale (UDysRS) total score by 37%, compared to 12% for placebo at week 12. In the second study, the drug led to a decrease in the UDysRS total score by 46%, compared to 16% for placebo.
Gocovri also increased functional time for patients taking the drug. In the first study, patients gained 3.6 hours of functional time, and patients gained 4 hours in the second study.
“Today’s approval is a tremendous milestone for Adamas and for the Parkinson’s disease community,” said Gregory T. Went, CEO of Adamas Pharmaceuticals. “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.”
Adamas expects Gocovri to be available in the fourth quarter with an official launch set for January 2018.
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