Study to Determine the Efficacy and Safety of ELS-M11 in Acute Migraine

Inclusion Criteria: * Provide written informed consent * Males and females aged 18-65 who can read, write and understand English * Subject has at least a one year documented history of migraine headache (defined by International headache Society IHS) migraine definitions, with or without aura, with 2≤8 moderate or severe migraine attacks per month in the 2 months prior to the screening visit * Is stable on the current standard non-opioid rescue medication for at least 2 months prior to randomization * Can distinguish migraine from tension headache (HA), with 24 hours of freedom from HA between migraine events * Women of childbearing potential must be currently using or willing to use contraception (30 days prior to start of study medication and for 21 days after taking study medication) * Women of non-childbearing potential include females regardless of age, with functioning ovaries and who have a current documented tubal ligation \[Hatcher, 2004\] bilateral oophorectomy or total hysterectomy, or post-menopausal females * The subject is able and willing to perform the assessments and procedures as specified in this protocol, including the ability to learn and follow instructions for ePRO device Exclusion Criteria: * Migraineurs taking opioid-based rescue medications for any indication * Subject has history of mild migraine events or migraines that usually resolve spontaneously in less than 2 hours * Subject has menstrual migraines * Positive Drug Test * Subject has basilar or hemiplegic migraines * Subject has more than 15 headache-days per month * Subjects with a history of facial allodynia * Subject has a history of vomiting during more than 30% of migraine episodes * Self confinement to bed rest for more than 50% of migraine episodes * Subject was greater than 50 years old at age of migraine onset * Acute coronary syndrome (i.e., myocardial infarction and unstable angina), stroke or resuscitated cardiac arrest within the past 3 months * Severe congestive heart failure * Systolic blood pressure (sBP) \>160 mmHg or diastolic blood pressure (dBP) \>100 mmHg measured in the sitting position at Visit 1 * Current active renal disease * Any history of pyelonephritis * Evidence of active liver disease * Alanine aminotransferase (ALT), aspartate aminotransferase (AST) or alkaline phosphatase \>2 times the upper limit of the reference range (ULRR), or total bilirubin \>1.5 times the ULRR at Visit 1 * Past history of acute pancreatitis with current triglycerides 4.56 mmol/L (400 mg/dL) at Visit 1 * History of malignancy within the past 3 years, other than non-melanoma skin cancer (i.e., basal or superficial squamous cell carcinoma) and treated cervical cancer in-situ * Any planned major surgery to be performed during the study (e.g., coronary artery bypass surgery, abdominal aortic aneurysm repair, etc.) * Current life-threatening condition * Significant hypersensitivity to NSAIDs (e.g., difficulty swallowing or breathing, tachycardia, anaphylaxis, angioedema or skin reaction) * Pregnancy (defined by positive urine pregnancy test) or lactation at Visit 1, or planning to become pregnant prior to completion of the study * History or suspicion of alcohol or substance abuse (current or past 6 months). * Participation in any clinical trial within 30 days prior to Visit 1 * Subjects with a history of hypersensitivity to products containing tiaprofenic acid, suprofen, fenofibrate, oxybenzone, or octocrylene (e.g., sunscreen, perfume) * Subjects with a history of photosensitivity * Any clinically significant abnormality or any reason that the subject may not be able to complete the full study observational period