Efficacy and Safety of 20 mg Sumatriptan Powder Delivered Intranasally With the Bi-directional Device Compared With 100 mg Sumatriptan Tablets in Adults With Acute Migraine With or Without Aura

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)
• •Current treatment with monoamine oxidase A (MAO-A) inhibitors or use within 4 weeks before randomization
• •Have hemiplegic or basilar migraine
• •History, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascular syndromes. Ischemic cardiac syndromes include, but are not limited to, angina pectoris of any type (e.g., stable angina of effort, vasospastic forms of angina such as the Prinzmetal variant), all forms of myocardial infarction and silent myocardial ischemia. Cerebrovascular syndromes include, but are not limited to, strokes of any type as well as transient ischemic attacks. Peripheral vascular disease includes, but is not limited to, ischemic bowel disease, Raynaud syndrome
• •Uncontrolled hypertension (screening systolic/diastolic blood pressure \>140/95 mmHg)
• •Have severe hepatic impairment
• •Have history of epilepsy or conditions associated with a lowered seizure threshold
• •History (within 2 years) of drug or alcohol abuse as defined by Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria