Adamas Pharmaceuticals Inc. (NASDAQ: ADMS) received approval from the FDA for its drug GOCOVRI. This drug is used to treat Dyskinesia in patients with Parkinson's.
Prior to the approval of the drug, the FDA had not approved of any drugs to treat Dyskinesia. This FDA approval puts Adamas in a very secured spot for the drug as it faces zero competition, according to SeekingAlpha.
Dyskinesia is a consequence of levodopa-based Parkinson's disease treatment and is characterized by involuntary and non-rhythmic movements that are purposeless and unpredictable, which impact the activities of daily living, according to the statement.
The drug was approved by the FDA for its positive results from two phase 3 clinical trials. In the first trial results showed a reduction in Dyskinesia by 37 percent on the Unified Dyskinesia Rating Scale compared to a 12 percent for placebo at week 12. The second trial proved to be even better as results showed a 46 percent reduction compared to 16 percent for placebo, significantly better than the first trial.
The company has not set a price yet for the drug, but according to an email received by John Carroll of Endpoint News, the company expects the price to be listed around $10,000 to $30,000. The final price of the drug will be dependent on the patient access to the drug.
The drug is a dose of 274 mg amantadine that is taken once a day and delivers consistent high levels of amantadine from the morning and throughout the day when dyskinesia occurs.
GOCOVRI is expected to be available in the fourth quarter, and launched by January 2018.
"Today's approval is a tremendous milestone for Adamas and for the Parkinson's disease community," said Gregory T. Went, Ph.D., Founder, Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. "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."