Acute Treatment Trial in Adult Subjects With Migraines

Inclusion Criteria: Key Inclusion Criteria:

1. Participants have at least 1-year history of migraines (with or without aura),consistent with a diagnosis according to the International Classification of HeadacheDisorder, 3rd Edition, including the following:
2. Migraine attacks present for more than 1 year with the age of onset prior to 50 yearsof age.
3. Migraine attacks, on average, lasting about 4-72 hours if untreated.
4. Not more than 8 attacks of moderate to severe intensity per month within the last 3months.
5. At least 2 consistent migraine headache attacks of moderate or severe intensity ineach of the 3 months prior to the Screening Visit and throughout the Screening Period.
6. Less than 15 days with headache (migraine or non-migraine) per month in each of the 3months prior to the Screening Visit and throughout the Screening Period.
7. Participants on prophylactic migraine medication are permitted to remain on therapyprovided they have been on a stable dose for at least 3 months prior to ScreeningVisit and the dose is not expected to change during the course of the study.
8. Participants with contraindications for use of triptans may be included provided theymeet all other study entry criteria.

Exclusion Criteria: Key Exclusion Criteria:

1. Participant with a history of basilar migraine or hemiplegic migraine.
2. Participant with a history of human immunodeficiency virus (HIV) disease.
3. Participant history with current evidence of uncontrolled, unstable or recentlydiagnosed cardiovascular disease, such as ischemic heart disease, coronary arteryvasospasm, and cerebral ischemia. Participants with myocardial infarction, acutecoronary syndrome, percutaneous coronary intervention, cardiac surgery, stroke ortransient ischemic attack during the 6 months prior to screening.
4. Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (howeversubjects can be included who have stable hypertension and/or diabetes for at least 3months prior to being enrolled).
5. Participant has a current diagnosis of major depression, other pain syndromes,psychiatric conditions (for example, schizophrenia), dementia, or significantneurological disorders (other than migraine) that, in the Investigator's opinion mightinterfere with study assessments.
6. Participant has a history of gastric, or small intestinal surgery (including gastricbypass, gastric banding, gastric sleeve, gastric balloon, etc.), or has disease thatcauses malabsorption.
7. The participant has a history of current or evidence of any significant and/ orunstable medical conditions (for example, history of congenital heart disease orarrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in theInvestigator's opinion, would expose them to undue risk of a significant adverse eventor interfere with assessments of safety or efficacy during the course of the trial.
8. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12months or subjects who have met Diagnostic and Statistical Manual of Mental DisordersFifth edition (DSM-V) criteria for any significant substance use disorder within thepast 12 months from the date of the Screening Visit.
9. History of nasal surgery in the 6 months preceding the Screening Visit.
10. Participation in any other investigational clinical trial while participating in thisclinical trial.