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

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)