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ARTICLE | Clinical News

Ibudilast: Preliminary Phase Ib/IIa data

January 10, 2011 8:00 AM UTC

Preliminary data from a double-blind, U.S. Phase Ib/IIa trial in 30 heroin-dependent patients showed that twice-daily 40 mg ibudilast met the primary endpoint of significantly reducing average SOWS scores from baseline vs. placebo (p<=0.05). Twice-daily 20 mg ibudilast missed the endpoint vs. placebo. Pupil restriction response to oxycodone was significantly greater from week 1 to week 2 for both treatment groups vs. placebo (p<0.05 for both). Oxycodone-induced analgesia was significantly higher from week 1 to week 2 for twice-daily 40 mg ibudilast (p<0.01). Ibudilast was well tolerated. Patients received placebo for week 1 and on day 8 were randomized to continue placebo or receive low- or high-dose ibudilast for 2 weeks. Patients were maintained on oral morphine for the first 2 weeks. MediciNova said the trial was not powered to detect statistical significance. ...