FDA Approves Almotriptan to Treat Migraines in Adolescents
Medscape Medical News
Yael Waknine
June 3, 2009 ? On April 30, the FDA approved an expanded indication for almotriptan malate (Axert tablets, Ortho-McNeil Janssen Pharmaceuticals) for the acute treatment of migraine headache in adolescents aged 12 to 17 years. Almotriptan previously was approved for use in adults only.
The approval was based on data from a double-blind, placebo-controlled, randomized study of 528 adolescents having at least a 1-year history of migraine attacks with or without aura and usually lasting 4 hours or more.
Results showed that the percentage of patients achieving a pain relief response (mild or no pain) 2 hours after treatment was statistically significantly greater with almotriptan 6.25 mg relative to placebo (71.8% vs 55.3%; P < .001); an increased dose of 12.5 mg almotriptan did not confer additional benefit (response rate, 72.9%).
The efficacy of almotriptan on migraine-associated symptoms was not established in the study, which showed a similar prevalence of nausea, photophobia, and phonophobia at 2 hours postdose across treatment and placebo groups.
Adverse events reported with almotriptan occurred in less than 5% of patients and most commonly included dizziness, nausea, vomiting, and headache.
As with adults, the recommended dose of almotriptan in adolescents is 6.25 or 12.5 mg. A second dose may be administered after 2 hours if headache returns, not to exceed a maximum daily dose of 25 mg.
Reduced doses of 6.25 mg should be used in patients with hepatic or severe renal impairment (maximum daily dose, 12.5 mg).
Because of the potential for serotonin syndrome, caution is advised with use of almotriptan in patients receiving concomitant treatment with selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors. Symptoms of serotonin syndrome may include autonomic instability, neuromuscular aberrations, and/or gastrointestinal effects.
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Comment:
As of this date the approval for Axert for use in adolescents has been given in the U.S. by the FDA. The product monograph on file at Health Canada shows Axert to be indicated in adults at this time.
It is unclear whether the manufacturer has applied to Health Canada for a change to the prescribing information in Canada. Individual physicians may make a therapeutic decision to prescribe a medication off label if its use can be supported based on available science.
Medscape Medical News
Yael Waknine
June 3, 2009 ? On April 30, the FDA approved an expanded indication for almotriptan malate (Axert tablets, Ortho-McNeil Janssen Pharmaceuticals) for the acute treatment of migraine headache in adolescents aged 12 to 17 years. Almotriptan previously was approved for use in adults only.
The approval was based on data from a double-blind, placebo-controlled, randomized study of 528 adolescents having at least a 1-year history of migraine attacks with or without aura and usually lasting 4 hours or more.
Results showed that the percentage of patients achieving a pain relief response (mild or no pain) 2 hours after treatment was statistically significantly greater with almotriptan 6.25 mg relative to placebo (71.8% vs 55.3%; P < .001); an increased dose of 12.5 mg almotriptan did not confer additional benefit (response rate, 72.9%).
The efficacy of almotriptan on migraine-associated symptoms was not established in the study, which showed a similar prevalence of nausea, photophobia, and phonophobia at 2 hours postdose across treatment and placebo groups.
Adverse events reported with almotriptan occurred in less than 5% of patients and most commonly included dizziness, nausea, vomiting, and headache.
As with adults, the recommended dose of almotriptan in adolescents is 6.25 or 12.5 mg. A second dose may be administered after 2 hours if headache returns, not to exceed a maximum daily dose of 25 mg.
Reduced doses of 6.25 mg should be used in patients with hepatic or severe renal impairment (maximum daily dose, 12.5 mg).
Because of the potential for serotonin syndrome, caution is advised with use of almotriptan in patients receiving concomitant treatment with selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors. Symptoms of serotonin syndrome may include autonomic instability, neuromuscular aberrations, and/or gastrointestinal effects.
------------------------------------------------------------------------
Comment:
As of this date the approval for Axert for use in adolescents has been given in the U.S. by the FDA. The product monograph on file at Health Canada shows Axert to be indicated in adults at this time.
It is unclear whether the manufacturer has applied to Health Canada for a change to the prescribing information in Canada. Individual physicians may make a therapeutic decision to prescribe a medication off label if its use can be supported based on available science.
