Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)

A Randomized, Double-blind, Single Migraine Attack, Placebo-controlled, Parallel-group Multicenter Study to Evaluate the Efficacy and Tolerability of Trexima (Sumatriptan Succinate.Naproxen Sodium) Tablets vs Placebo When Administered During the Mild Pain Phase of Menstrual Migraine in Women With Dysmenorrhea

This study was designed to determine efficacy of TREXIMET (sumatriptan/naproxen sodium), formerly known as TREXIMA compared to placebo for the treatment of a menstrual migraine.

A randomized, double-blind, single migraine attack, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and tolerability of TREXIMA* (sumatriptan succinate/naproxen sodium) tablets vs placebo when administered during the mild pain phase of menstrual migraine in women with dysmenorrhea (*TREXIMET)

Inclusion Criteria:

• At least a 6 month history of physician diagnosed migraine and typically experiences 2-6 migraine attacks per month
• Typically experiences moderate to severe migraine pain preceded by a mild pain phase
• Differentiate between mild migraine pain and other headache types
• Women of childbearing potential must be on adequate contraception

Exclusion Criteria:

• Pregnant and/or nursing mother
• History of cardiovascular disease
• Uncontrolled hypertension
• Basilar or Hemiplegic migraine
• History of stroke or transient ischemic attacks (TIA)
• History of epilepsy or treated with anti-epileptics within past 5 years
• Impaired hepatic or renal function
• History of gastrointestinal bleeding or ulceration
• Allergy or hypersensitivity to aspirin or any other NSAID
• Allergy or hypersensitivity to triptans
• Participated in an investigational drug trial in the previous 4 weeks