Positive Results Reported From Head-to-Head Comparison of Intranasal Versus Oral Sumatriptan for Migraine Pain
Intranasal form shows significant pain reduction within 30 minutes after use
The COMPASS trial, a head-to-head comparison of the investigational treatment AVP-825 (OptiNose/Avanir Pharmaceuticals) versus sumatriptan tablets (currently the most widely used prescription medication for migraine), has met its primary endpoint of a greater reduction in migraine pain during the first 30 minutes after treatment.
AVP-825 is a drug–device combination product consisting of a low dose of sumatriptan powder delivered intranasally using the new Bi-Directional Breath Powered device. If approved, AVP-825 would be the first fast-acting, dry-powder intranasal form of sumatriptan for the treatment of migraine.
A new drug application (NDA) for AVP-825 was filed earlier this year, and the FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of November 26, 2014.
The COMPASS study used a double-blind, double-dummy, cross-over design to compare AVP-825 (22 mg) with the highest approved dose of oral sumatriptan (100 mg). A total of 275 subjects with migraine were treated for 1,531 acute migraines with either AVP-825 (22 mg) plus a placebo tablet or placebo delivered with the Bi-Directional Breath Powered device plus a high-dose (100 mg) sumatriptan tablet. The study participants had up to 12 weeks in each randomly assigned period to treat up to 5 migraine attacks. Headache pain intensity and other symptoms were assessed immediately before dosing and at 10, 15, 30, 45, 60, 90, and 120 minutes after administration, with 24- and 48-hour follow-up.
The study showed that AVP-825 achieved early pain reduction in more headaches than did oral sumatriptan. In the trial’s primary endpoint, the intensity of headache pain was significantly lower with AVP-825 than with oral sumatriptan during the first 30 minutes (P < 0.0001). In addition, the trial achieved a statistically significant diference between the two treatments for relevant secondary measures of pain relief and freedom from pain as early as 15 minutes and at all of the early time points measured (i.e., 30, 45, 60, and 90 minutes).
The overall safety profile of AVP-825 was consistent with that observed in previous trials. Less than 2% of the subjects experienced an adverse event leading to treatment discontinuation with the use of either medication, and no serious adverse events occurred. Nasal discomfort and abnormal product taste were more common with AVP-825 than with oral sumatriptan; these adverse events were judged to be mild in nearly 90% of cases.
Source: PR Newswire; June 10, 2014.