The med bears the agency's orphan drug designation, and the approval follows two phase 3 studies that showed Gocovri could beat out placebo in reducing dyskinesia-a condition Adamas says affects almost 90% of Parkinson's patients receiving levodopa-based therapy.
Adamas may be the first company to have won FDA approval for a medication to treat dyskinesia in Parkinson's patients.
The drug is a 274-milligram dose taken daily at bedtime to deliver high levels of the drug throughout the day when dyskinesia occurs.
Specifically, Gocovri is approved to treat involuntary movements called dyskinesia associated with levodopa treatment of Parkinson's disease.
If investors had feared Adamas Pharmaceuticals Inc (NASDAQ:ADMS) could have been at risk of receiving a Complete Response Letter from the FDA for Gocovri (amantadine), a huge sigh of relief is echoing through Wall Street today. Gocovri is a proprietary extended-release formulation of amantadine HCl with a unique "chronotherapeutic" profile characterized by a slow initial increase in amantadine plasma concentrations; this is why the medication is expected to provide high plasma concentrations during the day and low plasma concentrations overnight.
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Amantadine is a weak NMDA antagonist, but has also been proven to increase dopamine release and block dopamine reuptake, and was granted an Orphan Drug Designation by the FDA for treating dyskinesia in levodopa-treated Parkinson's patients. 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.
"One can call it 'the first FDA-approved medicine for the treatment of dyskinesia in Parkinson's, ' and be technically correct, but not really", he added, raising the question of how much the new drug would cost over the generic price. "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". The placebo-adjusted reduction in off-time in both studies was approximately one hour per day.
An estimated 90 percent of levodopa-treated patients, about 200,000 people in the United States, suffer from LID, the company said. The most commonly observed adverse reactions (more than10% and greater than placebo) with Gocovri were hallucinations, dizziness, dry mouth, peripheral edema, constipation, fall, and orthostatic hypotension.
Meanwhile, the drugmaker and its rep army will be prepping for launch; the sales force will be formally deployed next January, the Adamas statement said.
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