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

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