Safety & Efficacy of a Single Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of a Single 20 mg Dose of Sumatriptan Powder Delivered Intranasally With the Bi-directional Device in Adults With Acute Migraine With or Without Aura

The study is being conducted to determine if OPTINOSE SUMATRIPTAN delivered nasally (through the nose) using the OPTINOSE SUMATRIPTAN Device can reduce the pain and symptoms associated with migraine headaches.

The primary objective for this study is to compare headache relief (defined as a reduction from moderate [Grade 2] or severe [Grade 3] pain to none [Grade 0] or mild [Grade 1] pain) at 120 minutes following a dose of 20 mg of OPTINOSE SUMATRIPTAN with placebo in the acute treatment of a single migraine attack.

Inclusion Criteria:

• Men or women, between the ages of 18 to 65 years
• Diagnosis of migraine, with or without aura
• Experiences between 1 and 8 migraine attacks per month for the past 12 months

Exclusion Criteria:

• Inability to distinguish other headaches from migraine
• Experiences headache of any kind at a frequency greater than or equal to 15 days per month
• History of resistance to sumatriptan, or non-response to 2 or more other triptans, defined as subjects who have not responded to an adequate dose and duration of treatment
• Current use of medication for migraine prophylaxis that has not been stable (no dose adjustment) for 30 days prior to screening
• Chronic opioid therapy (>3 consecutive days in the 30 days prior to screening)