Ecopipam: Interim Phase II data

Psyadon stopped the open-label, U.S. Phase II PSY301 trial after an interim analysis of 15 evaluable patients with Tourette's syndrome in the intent-to-treat (ITT) population showed that once-daily ecopipam met the primary endpoint of reducing YGTSS from baseline to week 8 (p<0.001). Specifically, ecopipam reduced mean YGTSS scores from baseline to week 8 by 5.5 points. Psyadon said ecopipam also met the endpoint in the modified intent-to-treat (mITT) population (n=12), which consisted of patients who completed all weekly assessments (p<0.001). Specifically, ecopipam reduced mean YGTSS scores from baseline to week 8 by 6.2 points in the mITT population. Ecopipam was well tolerated with fatigue, nausea, sedation, headache, restlessness and sleeplessness reported as the most common adverse events. Patients received once-daily 50 mg ecopipam for 2 weeks, followed by once-daily 100 mg for 6 weeks. The trial was designed to enroll about 25-30 patients. ...