XP13512: Phase II data

Top-line data from a double-blind, crossover Phase II trial in 96 evaluable patients showed that 3,600 mg/day Solzira met the primary endpoint of significantly reducing 24-hour average pain intensity score from baseline to the end of treatment vs.1,200 mg/day Solzira (1.47 vs. 1.18 points, p=0.013). The trial enrolled 138 patients with a history of inadequate response to gabapentin doses of >=1,800 mg/day. Patients received 1,200 mg/day Solzira for 28 days followed by 3,600 mg/day Solzira for 28 days; or 3,600 mg/day Solzira for 28 days followed by 1,200 mg/day Solzira for 28 days. All patients received 2,400 mg/day Solzira for 4 days between the two 28-day treatment periods. ...