More than a year after Adamas $ADMS posted positive results from a pivotal Phase III study of ADS-5102 — an extended-release version of the generic Parkinson’s treatment amantadine — the company got a green light from the FDA to sell the therapy.
The drug will be sold as Gocovri.
Probably not unexpectedly, the drug was able to beat out a placebo in significantly reducing the side effects of Parkinson’s. And the Emeryville, CA-based biotech boasts that this is the first and only drug approved for “dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy” — an orphan indication. The therapy is designed to help patients who suffer from the sharp, involuntary movement disorder brought on by levodopa, commonly used to control the disease.
Investors embraced the news, driving up shares by more than 35%.
The generic drug, though, is already used off label for dyskinesia, which may well interfere with the company’s sales expectations. Walid Gellad, an associate professor of medicine at the University of Pittsburgh, highlighted the off label use in a Tweet.
The approval marks a major shift for Adamas, which has been lining up job offers for 59 sales execs they believe can reach the vast majority of the physicians and specialists who handle the bulk of the cases. And the team there has been laying the groundwork with payers to help roll out the drug.
What Adamas doesn’t have right now is a price. “We anticipate a list price for Gocovri around the range of the previous disclosure: $10K – $30K,” the company told me in an email. The final price, they say, will be heavily influenced by patient access. In the US, wholesale prices are typically heavily discounted for major payers.
The generic drug is sold by online pharmacies, often for the flu or Parkinson’s, for a little more than $2 per 100 mg capsule.
Adamas ran two Phase III studies for the drug, demonstrating that it triggered a 37% reduction in Unified Dyskinesia Rating Scale (UDysRS) total score vs. 12 percent for placebo at week 12. The results were confirmed in the second study, with Gocovri achieving a 46% reduction in UDysRS vs. 16% for placebo.
The drug launch starts in January, according to Adamas, which can now wrap up its pre-launch efforts.
“Today’s approval is a tremendous milestone for Adamas and for the Parkinson’s disease community,” said Adamas CEO Gregory T. Went. “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.”
https://endpts.com/adamas-wins-its-first-fda-ok-setting-up-market-launch-for-a-reformulated-parkinsons-drug/
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