Intranasal sumatriptan powder: Phase I data

An open-label, 4-way crossover, U.S. Phase I trial in 20 healthy volunteers showed that 16 mg intranasal AVP-825 produced 27% higher peak plasma concentrations (Cmax) (20.8 vs. 16.4 ng/mL) and 75% more systemic exposure during the first 15 minutes post-dose compared to 20 mg Imitrex sumatriptan nasal spray. Systemic exposure over 14 hours was similar between AVP-825 and Imitrex nasal spray. AVP-825 was also associated with faster absorption compared to both Imitrex nasal spray and 100 mg oral Imitrex. AVP-825 led to significantly lower Cmax and total systemic exposure compared to both oral Imitrex and 6 mg Imitrex subcutaneous injection. No serious adverse events were reported. Subjects received a single dose of each of the 4 treatments each separated by a 7-day washout period. Data were published in Headache. ...