Efficacy, Tolerability, and Safety Study of DFN-15

Inclusion Criteria

• A history of episodic migraine, who experience 2 to 8 migraine attacks per month for at least the past 12 months, with no more than 14 headache days per month, and with 48 hours of headache-free time between migraine attacks.
• Patients who have migraine with or without aura with onset before age 50 years
• Report usual migraine pain of 2 (moderate) or 3 (severe) on headache pain severity scale without treatment.
• Subjects who are willing and able to:
• Evaluate and record pain, migraine symptoms, and study drug effectiveness information in real-time using a subject eDiary for the duration of the study;
• Record each instance of the use of study drug and rescue medication in real-time using a subject eDiary for the duration of the study;
• Comply with all other study procedures and scheduling requirements.

Exclusion Criteria

• Minors, even if they are in the specified study age range
• Medication overuse:
• Opioids greater than or equal to 10 days during the 90 days prior to screening
• Combination medications (e.g., Fiorinal®) greater than or equal to 10 days during the 90 days prior to screening (applies only if includes opioid and/or barbiturate)
• Nonsteroidal Anti-inflammatory Drugs or other simple medications greater than 14 days a month during the 90 days prior to screening
• Triptans or ergots greater than or equal to 10 days a month during the 90 days prior to screening
• Treated with onabotulinumtoxin A (Botox®) for migraine within 4 months prior to screening. (If treated for cosmetic reasons, subjects may be included).
• Current treatment with antipsychotics or use of antipsychotics within 30 days prior to randomization.
• Patients who have received treatment with an investigational drug or device within 30 days of randomization, or participated in a central nervous system clinical trial within 2 months prior to randomization
• Patients with positive screening test for human immunodeficiency virus [HIV], positive hepatitis B surface antigen (HBsAg), or positive hepatitis C virus [HCV] antibody
• Subjects who are employees or immediate relatives of the employees of the Sponsor, any of its affiliates or partners, or of the clinical research study site.