Adamas scores orphan approval for tweaked generic Parkinson's medication

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Adamas' Gocovri is an extended-release formulation of generic amantadine.

Adamas may be the first company to have won FDA approval for a medication to treat dyskinesia in Parkinson’s patients. But that doesn’t mean it’ll be the first company to use that med to treat it.

Thursday, the FDA green-lighted Adamas’ Gocovri as a treatment for movement disorder. 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 dyskinesiaa condition Adamas says affects nearly 90% of Parkinson’s patients receiving levodopa-based therapy. 

While the Emeryville, California-based company touted its regulatory win as an “important advancement,” industry-watchers were quick to point out that the med is a long-acting version of generic drug amantadine, marketed by Endo Pharmaceuticals as Symmetrel and used off-label to treat dyskinesia.

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Adamas certainly isn’t the first to put a tweaked generic up for FDA approval. Back in February, the agency gave Marathon Pharmaceuticals a go-ahead for Duchenne med Emflaza, a corticosteroid that had been on the market for decades outside the country and was cheaply imported to treat the deadly muscle-wasting disease.

And things didn’t go well for Marathon after that. Its $89,000 price tag on the drug sparked backlash from lawmakers and payer snubbing, forcing new owner PTC, which purchased the product, to shrink the cost dramatically.

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Adamas may be able to dodge that type of heat with its own list price, which isn’t yet set in stone but should fall between $10,000 and $30,000, the company said in a statement. The company believes that sticker “will reflect the benefit people living with Parkinson’s disease that suffer from dyskinesia will receive by getting 3.6 more hours of controlled function in their daily life,” the company said in a statement. It added that “this means significantly reduced episodes of unpredictable, uncontrolled movement that is disabling and embarrassing.”

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. It’ll consist of 59 reps, who will be able to reach about 85% of the doctors responsible for initiating Parkinson’s treatment, Adamas said.