Safety and Efficacy in Adult Subjects With Acute Migraines

Inclusion Criteria:

- Key Inclusion Criteria:

1. Patient has at least 1 year history of migraines (with or without aura), consistent
with a diagnosis according to the International Classification of Headache Disorder,
3rd Edition, Beta version[1] including the following:

- Not more than 8 attacks of moderate or severe intensity per month within last 3
months

- Consistent migraine headaches of at least 2 migraine headache attacks of moderate
or severe intensity in each of the 3 months prior to the Screening Visit and
maintains this requirement during the Screening Period

2. Less than 15 days with headache (migraine or non-migraine) per month in each of the 3
months prior to the Screening Visit and maintains this requirement during the
Screening Period

3. Patients on prophylactic migraine medication are permitted to remain on therapy
provided they have been on a stable dose for at least 3 months prior to study entry.

4. Patients with contraindications for use of triptans may be included provided they meet
all other study entry criteria.

Exclusion Criteria:

1. Patient history of HIV disease

2. Patient history with current evidence of uncontrolled, unstable or recently diagnosed
cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and
cerebral ischemia. Patients with Myocardial Infarction (MI), Acute Coronary Syndrome
(ACS),Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient
ischemic attack (TIA) during the 6 months prior to screening.

3. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however
patients can be included who have stable hypertension and/or diabetes for 3 months
prior to being enrolled)

4. Patient has a current diagnosis of major depression, other pain syndromes, psychiatric
conditions (eg, schizophrenia), dementia, or significant neurological disorders (other
than migraine) that, in the Investigator's opinion, might interfere with study
assessments

5. Patient has a history of gastric, or small intestinal surgery, or has a disease that
causes malabsorption.

6. The patient has a history or current evidence of any significant and/or unstable
medical conditions (eg, history of congenital heart disease or arrhythmia, known
suspected infection, hepatitisB or C, or cancer) that, in the investigator's opinion,
would expose them to undue risk of a significant adverse event (AE) or interfere with
assessments of safety or efficacy during the course ofthe trial

7. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12
months or patients who have met DSM-V criteria[15] for any significant substance use
disorder within thepast 12 months from the date of the screening visit.