Acute Treatment Trial in Adult Subjects With Migraines

Inclusion Criteria:

1. Subject 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:

1. Migraine attacks present for more than 1 year with the age of onset prior to 50 years
of age

2. Migraine attacks, on average, lasting about 4-72 hours if untreated

3. Not more than 8 attacks of moderate to severe intensity per month within the last 3
months

4. At least 2 consistent 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

5. 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.

6. Subjects 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 screening
visit and the dose is not expected to change during the course of the study.

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

Exclusion Criteria:

Key Exclusion Criteria:

1. Subject with a history of HIV disease

2. Subject history with current evidence of uncontrolled, unstable or recently diagnosed
cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and
cerebral ischemia. Subjects 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
subjects can be included who have stable hypertension and/or diabetes for at least 3
months prior to being enrolled).

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

5. Subject has a history of gastric, or small intestinal surgery (including Gastric
Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that
causes malabsorption.

6. The subject has a history of current or evidence of any significant and/ or unstable
medical conditions (e.g., history of congenital heart disease or arrhythmia, known
suspected infection, hepatitis B 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 of the trial.

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

8. History of nasal surgery in the 6 months preceding the screening visit.

9. Participation in any other investigational clinical trial while participating in this
clinical trial.