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Intranasal Sumatriptan Powder Shows Promise in Migraine Study
Positive results from a pivotal phase III study of AVP-825 (Avanir Pharmaceuticals) have been published online in the journal Headache.
AVP-825 is an investigational drug–device combination product consisting of low-dose sumatriptan powder (22 mg) delivered intranasally using “Breath Powered” delivery technology for the acute treatment of migraine.
A new drug application (NDA) for AVP-825 has been accepted by the FDA and is currently under review, with a Prescription Drug User Fee Act (PDUFA) goal date of November 26, 2014.
The pivotal TARGET trial was a double-blind, placebo-controlled study involving 230 subjects with migraine. The participants were randomly assigned to self-administer either AVP-825 or placebo using the Breath Powered device when they had moderate-to-severe migraine pain. Pain scores were then assessed at various time points after administration. Pain was evaluated using a four-point scale, with headache relief defined as a reduction from moderate (grade 2) or severe (grade 3) pain to mild (grade 1) pain or complete relief (grade 0).
The study data demonstrated relief of moderate or severe migraine headache as quickly as 15 minutes (19.4% for AVP-825 vs. 14.4% for placebo device) in subjects receiving AVP-825. Compared with those using the placebo device, a significantly greater proportion of AVP-825 patients reported headache relief at 30 minutes (41.7% for AVP-825 vs. 26.9% for placebo device; P = 0.03) and at every time point up to 2 hours post-dose (67.6% vs. 45.2%; P = 0.002). Pain relief was sustained through 24 and 48 hours in a greater proportion of patients who received AVP-825 compared with those using the placebo device.
The treatment was well tolerated, with a low incidence of adverse events (AEs). The most common AEs included product taste (22%), nasal discomfort (13%), and rhinitis (3%).
If approved, AVP-825 would be the first fast-acting, dry-powder intranasal form of sumatriptan for the treatment of migraine. Sumatriptan is contraindicated for certain patients, including those with a history of coronary artery disease or coronary vasospasm.
The Breath Powered delivery technology is activated by the user’s breath to propel medications deep into the nasal cavity. The user exhales into the device, automatically closing the soft palate and sealing off the nasal cavity. Through a sealing nosepiece placed into the nostril, the exhaled breath carries medication from the device directly into one side of the nose. Narrow nasal passages are expanded, and the medication is dispersed deep into the nasal cavity, reaching areas where it can be rapidly absorbed. As the medication is delivered, the air flows around to the opposite side of the nasal cavity and exits through the other nostril. Closure of the soft palate helps prevent swallowing of the sumatriptan powder or inhalation into the lungs.
According to the Centers for Disease Control and Prevention, more than 37 million Americans experience migraine headaches. The triptan class of medications is generally considered the standard of care, with more than 13 million prescriptions written annually. Sumatriptan is the most commonly prescribed migraine treatment in the U.S. In a recent study, more than 40% of migraine patients reported that they were not satisfied with their current medication, and 80% were willing to try another medication.
Sources: Avanir Pharmaceuticals; October 30, 2014; and Headache; October 30, 2014.