Phase III results show benefits for dyskinesia with Gocovri in Parkinson's disease.- Adamas Pharmaceuticals.

Adamas Pharmaceuticals announced the presentation of new data analysis of Gocovri (amantadine) extended release capsules, from the Phase III pivotal studies, demonstrating that the reductions in both dyskinesia and OFF experienced by Gocovri-treated patients results in longer periods of ON time without troublesome dyskinesia and reduced transitions between Parkinson's disease diary states. During the study, 162 patients (77 treated with Gocovri and 85 with placebo) provided a complete and evaluable Parkinson's disease home diary at both baseline and Week 12.

At Week 12, the reductions in both dyskinesia and OFF for Gocovri-treated patients resulted in much longer periods of ON time without troublesome dyskinesia. Gocovri-treated patients, on average, experienced a 3.2-hour placebo adjusted increase in their first episode of ON time without troublesome dyskinesia. In addition, at Week 12, Gocovri-treated patients experienced 4.2 less transitions between diary states a day compared to 2.0 less transitions for placebo-treated patients. Approximately 17 percent of Gocovri-treated patients become transition-free versus approximately one percent of placebo-treated patients.

The safety data was consistent with the overall population of the pivotal trials for Gocovri. The most common adverse reactions (>10 percent) were hallucination, dizziness, dry mouth, peripheral edema, constipation, falls, and orthostatic hypotension. The analysis was presented at the 2nd Annual Pan American Parkinson's Diseases and Movement Disorders Congress.

Comment: Levodopa is a standard treatment for Parkinsons disease but comes with severe side effects (levodopa induced dyskinesia) that worsen with continued exposure to the drug that is estimated to affect some 15% of Parkinsons patients. Gocovri is a high dose 274 mg amantadine (equivalent to 340 mg amantadine HCl) taken once-daily at bedtime that delivers consistently high levels of amantadine from the morning and throughout the day when dyskinesia occurs.