The FDA approved extended-release amantadine (Gocovri) capsules as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) who are experiencing “off” episodes.
As PD progresses, patients who are using levodopa-based therapy are likely to suffer from periods of symptom resurgence known as “off” episodes. Amantadine, a once-daily capsule that was first approved in 2017 to treat dyskinesia in patients who are receiving levodopa-based therapy, is now the first approved medication to treat both “off” and dyskinesia-related motor complications in PD, the drug’s manufacturer, Adamas Pharmaceuticals, Inc., explained in a company press release.
This latest approval was based on results from a pair of phase III placebo-controlled clinical trials that evaluated the efficacy and safety of amantadine capsules in the treatment of dyskinesia among 196 patients with PD who were experiencing “off” episodes. Patients were randomized to receive either a once daily 274 mg dose of amantadine or placebo. Results showed that there was a clinically significant increase in “on” time, or time without symptom recurrence, as well as a reduction in dyskinesia from baseline to week 12 in the amantadine group.
The drug also demonstrated “sustained efficacy for at least 2 years in the phase III, open-label EASE LID-2 study,” the manufacturer added.
According to the FDA-approved prescribing information for amantadine, the drug is contraindicated in patients with end-stage renal disease, and a lower dose is recommended for patients with moderate or severe renal impairment. The agency also warned that PD patients taking amantadine may experience drowsiness and falling asleep during daily activities, suicidality and depression, hallucinations or psychotic behavior, dizziness, orthostatic hypotension, or impulse control/impulsive behaviors, as well as withdrawal-emergent hyperpyrexia and confusion upon sudden discontinuation of the drug.
The most common adverse reactions associated with use of amantadine — experienced by over 10% of trial participants — included hallucination, dizziness, dry mouth, peripheral edema, constipation, fall, and orthostatic hypotension, the agency added.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 37
Topic ID: 82,37,730,37,192,725,925
