t; or by concomitant use of common migraine prophylactic drugs (e.g., beta-blockers, calcium channel blockers, and tricyclic antidepressants); or oral contraceptives. There were insufficient data to assess the effect of race on efficacy.
14.2 Adolescents Age 12 to 17 Years
The efficacy of AXERT® in adolescent patients age 12 to 17 years was eva luated in a double-blind, randomized, placebo-controlled study. Patients enrolled in that study had at least a 1-year history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated). Patients enrolled in the study were primarily females (60%) and Caucasian (75%), while 15% of patients were black, and 10% were of other races. Patients were instructed to treat a moderate to severe migraine headache. Two hours after taking one dose of study medication, patients eva luated their headache pain. Associated symptoms of nausea, photophobia, and phonophobia were also eva luated.
In this study, the percentage of patients achieving a pain relief response (mild or no pain) 2 hours after treatment was statistically significantly greater in patients who received AXERT® 6.25 mg or 12.5 mg compared with those who received placebo. There was no additional benefit on pain relief provided by the 12.5 mg dose. The 2-hour pain relief results are summarized in Table 4.
Table 4. Response Rates 2 Hours Following Treatment of Initial Headache in Adolescents Age 12 to 17 Years
Placebo AXERT® 6.25 mg AXERT® 12.5 mg
* p value 0.001 in comparison with placebo † p value <0.001 in comparison with placebo
Study 1 55.3%
(n/N = 94/170) 71.8%*
(n/N = 127/177) 72.9%†
(n/N = 132/181)
The estimated probability of achieving pain relief within 2 hours following initial treatment with AXERT® in adolescents age 12 to 17 years is shown in Figure 3.
Figure 3. Estimated Probability of Achieving an Initial Headache Response (Mild or no Pain) in 2 Hours in the Adolescent Study
Figure 3
The preva lence of the migraine-associated symptoms (nausea, photophobia, and phonophobia) at 2 hours after taking the dose was not significantly different between patients who received AXERT® 6.25 mg or 12.5 mg and those who received placebo.
16 HOW SUPPLIED/STORAGE AND HANDLING
AXERT® (almotriptan malate) Tablets are available as follows:
6.25 mg: White, coated, circular, biconvex tablets with red code imprint "2080."
Unit Dose (aluminum blister pack)
6 tablets NDC 50458-211-01
12.5 mg: White, coated, circular, biconvex tablets with blue stylized imprint "A."
Unit Dose (aluminum blister pack)
12 tablets NDC 50458-210-01
Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Drug Interactions
Advise patients to talk with their physician or pharmacist before taking any new medicines, including prescription and non-prescription drugs and supplements [see CONTRAINDICATIONS (4.5) and (4.6) and DRUG INTERACTIONS (7)].
Hypersensitivity
Inform patients to tell their physician if they develop a rash, itching, or breathing difficulties after taking AXERT® [see WARNINGS AND PRECAUTIONS (5.8)].
Risk of Myocardial Ischemia and/or Infarction, Other |
