Staccato loxapine: Preliminary Phase IIb data

Preliminary data from a double-blind Phase IIb trial in 366 patients showed that both 1.25 and 2.5 mg doses of inhaled AZ-104 missed the primary endpoint of pain relief at 2 hours post-dose vs. placebo. Specifically, pain relief occurred in 54% and 56% of patients in the respective low- and high-dose AZ-104 groups vs. 45% for placebo (p=0.11 and p=0.12, respectively). The low- and high-doses of AZ-104 also missed the secondary endpoint of percentage of pain-free responders at 2 hours post-dose vs. placebo (27% and 31%, respectively, vs. 23% for placebo). AZ-104 was well tolerated and there were no serious adverse events. ...