A Study of Combination Product (Sumatriptan Succinate and Naproxen Sodium) in Migraine Subjects Who Report Poor Response or Intolerance to Short Acting Triptans (Study 1 of 2)

Exclusion Criteria

• •Subject has non-migraine headache, retinal migraine, basilar or hemiplegic migraine, cluster headache, or headaches secondary to trauma, cranial or cervical disorders, infections, alterations of homeostasis, ENT disorders, psychiatric disorders or cranial neuralgias.
• •Subject has confirmed or suspected ischemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischemia), Prinzmetal's angina/coronary vasospasm, or signs/symptoms consistent with any of the above.
• •Subject has evidence or history of ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome.
• •Subject has cardiac arrhythmias requiring medication or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study.
• •Subject has a history of cerebrovascular pathology including stroke and/or transient ischemic attacks (TIAs).
• •Subject has a history of congenital heart disease.
• •Subject has uncontrolled hypertension at screening (sitting systolic pressure ≥140mmHg, diastolic pressure ≥90mmHg).
• •Subject, in the investigator's opinion, is likely to have unrecognized cardiovascular or cerebrovascular disease (based on history or the presence of risk factors including but not limited to, hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of coronary artery disease, female with surgical or physiological menopause, or male over 40 years of age).
• •Subject has a history of epilepsy or structural brain lesions which lower the convulsive threshold or treated with an antiepileptic drug for seizure control within 5 years prior to screening.
• •Subject has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study.
• •Subject is currently taking a monoamine oxidase inhibitor (MAOI), or has taken a MAOI within 2 weeks prior to screening or plans to take within 2 weeks after treatment.
• •Subject is currently taking, or has taken in the previous three months, a migraine prophylactic medication containing methysergide or dihydroergotamine; or is taking a medication that is not stabilized (i.e. change of dose within the past 2 months) for either chronic or intermittent migraine prophylaxis or for a co-morbid condition that is not stabilized..
• •Subject is currently taking any anti-coagulant (e.g., warfarin).
• •Subject has a recent history of regular use of opioids or barbiturates for treatment of their migraine headache and/or other non-migraine pain. Regular use is defined as an average of 4 days per month over the last 6 months.
• •Subject is currently taking or has taken in the previous 4 weeks, herbal preparations containing St. John's Wort (Hypericum perforatum).
• •Subject has hypersensitivity, intolerance, or contraindication to the use of sumatriptan or naproxen sodium or any of their components or any other 5-HT1 receptor agonist.
• •Subject has a history of allergic reactions to naproxen preparations, including subject in whom aspirin or other NSAID drugs induce the syndrome of asthma, rhinitis, and nasal polyps.
• •Subject has a history of any gastrointestinal surgery that specifically indicates a past history of bleeding, ulceration or perforation.
• •Subject has a history of gastric bypass or stapling surgery.
• •Subject has a history of GI ulceration in the past six months or gastrointestinal bleeding in the past year.
• •Subject has a history of inflammatory bowel disease.
• •Subject has a history of any bleeding disorder.
• •Subject is taking any antiplatelet agent (except low-dose aspirin ≤ 325mg/day for cardioprotective reasons).
• •Subject is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
• •Subject is pregnant, actively trying to become pregnant or breast-feeding.
• •Subject has evidence of alcohol or substance abuse within the last year which, in the investigator's judgment, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results.
• •Subject has any concurrent medical or psychiatric condition which, in the investigator's opinion, may affect the interpretation of efficacy and safety data or which otherwise contraindicates participation in this clinical trial.
• •Subject has participated in an investigational drug trial within the previous four weeks or plans to participate in another study at any time during this study.