Adamas Pharmaceuticals (NASDAQ:ADMS) announces positive results from a Phase 3 clinical trial, INROADS, evaluating Gocovri (amantadine) (ADS-5102) in multiple sclerosis (MS) patients with walking impairment.
The study met the primary endpoint demonstrating a statistically significant improvement in response rate compared to placebo as determined by at least a 20% improvement in walking speed from baseline at week 12 in a Timed 25 Foot Walk. Specifically, patients receiving 274 mg of ADS-5102 each day showed a 21.1% response rate versus 11.3% for control (p=0.01). The response rate was 17.6% in the 137 mg dose arm but the separation from placebo was not statistically valid.
Neither dose sufficiently separated from placebo on the secondary walking measures.
On the safety front, the discontinuation rates in the 274 mg and 137 mg arms were 20.5% and 6.4%, respectively, compared to 3.8% in the control arm. The most common (>5%) treatment-related adverse events were peripheral edema, dry mouth, fall, constipation, urinary tract infection and insomnia.
The FDA approved Gocovri in August 2017 for Parkinson’s disease-related dyskinesia.
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