Adamas Announces Patent for GOCOVRI in Parkinson’s Disease

Adamas Pharmaceuticals has been issued a new patent (no. 10,646,456) by the United States Patent and Trademark Office (USPTO) that covers GOCOVRI® (amantadine) extended release capsules. The new patent covers a method of reducing ‘OFF’ time and increasing ‘good ON’ time (ON time without troublesome dyskinesia) in people with Parkinson’s disease (PD) being treated with levodopa. GOCOVRI is indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. Data from two pivotal, placebo-controlled phase 3 clinical studies showed that GOCOVRI reduced dyskinesia, as well as a secondary benefit in reduction of OFF time, leading to an increase in good ON time.

This is the second patent to be issued for GOCOVRI that covers reduction in OFF time and will expire in 2034. Adamas’ portfolio of patents for GOCOVRI now includes 15 U.S. patents, across three separate patent families that will expire from 2025 to 2034. This latest addition is listed in the U.S. Food and Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.

GOCOVRI® (amantadine) extended-release capsules is the first and only FDA-approved medicine indicated for the treatment of dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. It is also the only medicine clinically proven to reduce both dyskinesia and OFF. Taken once daily at bedtime, GOCOVRI provides an initial lag and a slow rise in amantadine concentration during the night, resulting in a high concentration from the morning and throughout the waking day. Additionally, in the clinical trials, the adjunctive use of GOCOVRI did not require dose changes to dopaminergic therapies. The most commonly observed adverse reactions with GOCOVRI were hallucinations, dizziness, dry mouth, peripheral edema, constipation, falls and orthostatic hypotension.