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The FDA recently approved two new sumatriptan formulations for the treatment of migraine.
Avanir Pharmaceutical’s Onzetra Xsail, formerly known as AVP-825, has been approved for the acute treatment of migraine with or without aura in adults. The medication, which is delivered intranasally through the brand’s novel Xsail Breath Powered Delivery System, is meant to be a fast-acting therapy that is quickly absorbed through the many blood vessels inside the nose.
Approval is based on results from phase II and phase III trials, as well as safety data from 300 patients. In the TARGET trial, 41.7% of participants randomized to Onzetra reported headache relief at 30 minutes compared to 26.9% of participants randomized to placebo (P=0.03). The treatment was well tolerated and was associated with a low incidence of adverse events, with the most common being abnormal product taste, nasal discomfort, rhinorrhea, and rhinitis.
The FDA also approved the Zembrace SymTouch, a drug-device combination product manufactured by Dr. Reddy’s Laboratories based in Hyderabad, India. The treatment is Iintended for adults with migraine with or without aura who are currently inadequately managed with current treatment and may not be able to accept treatment in pill form, possibly due to migraine-related nausea.
The Zembrace SymTouch will be available as a pre-filled, single-dose disposable autoinjector containing 3 mg of sumatriptan. The injection is intended to be given subcutaneously. The product will be marketed in the U.S. by Promius Pharma.
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