OptiNose has enrolled the first patient in a Phase III study involving the intranasal delivery of Sumatriptan powder using its bi-directional technology.
The randomized double-blind placebo-controlled parallel group AssessmenT of Delivery of Drug via A Novel Device to the IntRanasal Cavity for MiGraine PatiEnTs (TARGET) study will include around 200 subjects aged 18-65 years with a diagnosis of acute migraine with or without aura.
The TARGET study is designed to assess the safety and efficacy of the OptiNose migraine product, and also to evaluate the ability of providing rapid pain relief and sustained freedom from pain.
The primary goal of the trial is to evaluate headache relief at 120 minutes following a 20 mg dose of Sumatriptan delivered using the OptiNose device.
OptiNose’s bi-directional nasal delivery technology considerably improves delivery to targeted sites deep into the nose.