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

Inclusion Criteria:

• Man or woman, between the ages of 18 to 65 years, inclusive at screening

• Have a diagnosis of episodic migraine, with or without aura according toInternationalClassification of Headache Disorders (2nd Edition) (ICHD-2) for at least 1 year prior to screening

• Experiences between 2 and 8 migraine attacks per month for the past 12 months

• Women of child bearing potential must be practicing an effective method of birthcontrol

• Women of child-bearing potential must have a negative urine pregnancy test at thescreening visit and a negative urine pregnancy test at the randomization visit

• Demonstrate the ability to use the bi-directional delivery device correctly

• Able and willing to read and comprehend written instructions and complete theelectronic diary information required by the protocol

• Must be capable, in the opinion of the Investigator, of providing informed consent toparticipate in the study. Subjects (and their legally acceptable representatives, ifapplicable) must sign an informed consent document indicating that they understand thepurpose of and procedures required for the study and are willing to participate in thestudy

Exclusion Criteria:

• Inability to distinguish other headaches from migraine

• Experiences headache of any kind at a frequency greater than or equal to 15 days permonth

• 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 oftreatment

• Current use of medication for migraine prophylaxis that has not been stable (no doseadjustment) 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 weeksbefore randomization

• Have hemiplegic or basilar migraine

• History, symptoms or signs of ischemic cardiac, cerebrovascular or peripheral vascularsyndromes. Ischemic cardiac syndromes include, but are not limited to, angina pectorisof any type (e.g., stable angina of effort, vasospastic forms of angina such as thePrinzmetal variant), all forms of myocardial infarction and silent myocardialischemia. Cerebrovascular syndromes include, but are not limited to, strokes of anytype as well as transient ischemic attacks. Peripheral vascular disease includes, butis 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 andStatistical Manual of Mental Disorders 4th edition (DSM-IV) criteria