Trial Outcomes & Findings for Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine (NCT NCT01300546)

Recruitment period was from date of Institutional Review Board (IRB) approval (11-30-10) until date last patient enrolled (1/3/12). Subjects were recruited from general population at two clinical research centers.

Subjects must complete a 30 day Baseline Period between Visit 1 and Visit 2 before Randomization. Subjects must have had 6-14 headache days during the 30 day Baseline Period in order to be Randomized into the Study Treatment Period. Fifty nine subjects were screened for study; however, only 39 subjects randomized for treatment due to screen fail.

Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine

Comparing the number of migraine headache days during Baseline Period Days 1-30 to number or migraine headache days reported in Treatment Period Days 91-120 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change=\[ (total headache days during Treatment Period Month 3 (Days 91-120)-total headache days during Baseline (Days 1-30)/total headache days during Baseline (Days 1-30)\]\*100%).

Comparing the number of migraine attacks reported from Baseline to the number of migraine attacks reported in Treatment Period Months 1(Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Each treatment month percent change was individually compared to Baseline. The following formula was used for each treatment period calculation. e.g.,Percent change=\[ (total migraine attacks days during Treatment Period Month 3 (Days 91-120)-total migraine attacks during Baseline (Days 1-30)/total migraine attacks during Baseline (Days 1-30)\]\*100%).

Comparing migraine severity 2 hours after treatment from Baseline(Days 1-30) to migraine severity reported 2 hours after treatment in Treatment Period Months 1 (Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from Treatment Period Month 3 and Baseline, then comparing the average change between each arm. The following formula was used for each treatment period calculation. e.g.,Percent change=\[ (mean migraine severity during Treatment Period Month 3 (Days 91-120)- mean migraine severity during Baseline (Days 1-30)/mean migraine severity during Baseline (Days 1-30)\]\*100%).

Comparing mean migraine duration from onset to painfree from Baseline(Days 1-30) to each month: Treatment Period Months 1 (Days 31-60), 2(Days 61-90), and 3(Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change was calculated by determining percent change in each subject, from Treatment Period Month 3 and Baseline, then comparing the average change between each arm. The following formula was used for each treatment period calculation. e.g.,Percent change=\[(mean duration from onset to painfree during Treatment Period Month 3 (Days 91-120)- mean duration from onset to painfree during Baseline (Days 1-30)/mean duration from onset to painfree during Baseline (Days 1-30)\]\*100%).

% change from Baseline in mean migraine duration from time of treatment to pain free reported in Treatment Period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Percent change=\[(mean duration from treatment to painfree during Treatment Period Month 3 (Days 91-120)- mean duration from treatment to painfree during Baseline (Days 1-30)/mean duration from treatment to painfree during Baseline (Days 1-30)\]\*100%).

Number of subjects with at least a 50% reduction in number of headache days reported in Baseline versus Treatment period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.

Number of subjects with at least a 50% reduction in number of migraine attacks reported in Baseline versus Treatment period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm

Total number of doses of study medication reported taken per participant in Treatment Period Months 1, 2, and 3 in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.

% change in number of doses during Baseline of triptans (Group A) and non-steroidal anti-inflammatory drugs(NSAIDs) (Group B) vs. doses during Treatment Period Months 1, 2, and 3 of study medication in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. e.g.,Percent change=\[(number of doses during Treatment Period Month 3 (Days 91-120)- number of doses during Baseline (Days 1-30)/number of doses during Baseline (Days 1-30)\]\*100%). The total number of subjects used in this analysis is different than the total number of subjects as the analysis is only looking at those subjects that were taking one of the study medications during Baseline.

Change in MIDAS total score from end of Baseline (Day 31) to end Treatment Period month 3 (Day 121) in the Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. Total score of disability ranges: * 0 to 5, MIDAS Grade I, Little or no disability * 6 to 10, MIDAS Grade II, Mild disability * 11 to 20, MIDAS Grade III, Moderate disability * 21+, MIDAS Grade IV, Severe disability No subscales are present.

Self-assessed grade of compliance with lifestyle modification changes (where A=1, B=2, C=3, D=4, and F=5; lower scores represent better outcomes) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm.

Comparing the number of migraine headache days during Baseline Period Days 1-30 to number or migraine headache days reported in Treatment Period Month 1 (Days 31-60), Treatment Period Month 2 (Days 61-90), and Treatment Period Month 3 (Days 91-120) in Sumatriptan/Naproxen Sodium arm vs. Naproxen Sodium arm. e.g., Percent change=\[ (total headache days during Treatment Period Month 3 (Days 91-120)-total headache days during Baseline (Days 1-30)/total headache days during Baseline (Days 1-30)\]\*100%).