Phase III INROADS study of ADS 5102 meets primary endpoint in multiple sclerosis.- Adamas Pharma

Adamas Pharmaceuticals announced that INROADS, a phase III 3-arm, randomized, double-blind, placebo-controlled study of ADS 5102 (amantadine HCl extended release) in 594 multiple sclerosis (MS) patients with walking impairment met its primary endpoint. Results from the study showed that patients taking 274 mg ADS 5102 had a statistically significant improvement in response rate of 21.1% compared to 11.3% taking placebo (p=0.01). Response was defined as at least a 20% improvement in walking speed from baseline to 12 weeks post-treatment, as measured by the Timed 25 Foot Walk.

Additionally, the response rate for patients taking a lower dose of 137 mg ADS-5102 was 17.6% (p=0.08). ADS-5102 did not demonstrate a significant effect on the secondary walking measures at either dose. The most common adverse events (occurring in greater than 5% of any ADS-5102 treatment group) were: peripheral edema, dry mouth, fall, constipation, UTI, and insomnia. 20.5% of patients discontinued study drug due to adverse events in the 274 mg group, compared to 6.4% in the 137 mg group, and 3.8% in the placebo group. The reported adverse events associated with ADS-5102 in this study were dose-dependent and consistent with the known safety profile of amantadine.