Now Available in Canada: First and Only Triptan Indicated for Migraine Relief in Adolescents

~ AXERT® is well-tolerated and effective at achieving pain relief for adolescents and adults ~

MARKHAM, ON, Sept. 8, 2011 /CNW/ - Johnson & Johnson Inc. announced that Health Canada has approved AXERT® (almotriptan malate tablets) for the acute treatment of migraine with or without aura in adolescents, ages 12 to 17.1  With this new indication, Canadian adolescents with migraine pain now have a treatment option available that is well-tolerated and effective at achieving and maintaining pain relief.1, 2  AXERT® has been used effectively in Canadian adults with acute migraine pain since 2003.

The availability of AXERT® represents a new option for the 10 to 15 per cent of Canadian adolescents who suffer from migraines.3,4  A key clinical trial demonstrated that significantly more adolescents achieved two-hour pain relief with AXERT® versus placebo (72.9% of AXERT® 12.5 mg patients and 71.8% of AXERT® 6.25 mg patients achieved pain relief within two hours).1

"Migraine headaches in teenagers are common, disabling and insufficiently treated, which is why it is encouraging to see a treatment option now available that we know has been very beneficial in the adult population," says Dr. Jonathan Gladstone, a neurologist and Director of the Gladstone Headache Clinic in Toronto.  "The efficacy of AXERT® along with its well-tolerated side effect profile makes it a welcomed new treatment option for physicians, parents and adolescents."

IMPACT OF MIGRAINES ON DAILY LIFE

Headache is one of the most common health issues in childhood and adolescent years.5  One-third of teenagers experience a headache at least once a week, with more than 30 per cent of those being migraineurs.6  Migraines have a large impact on the daily lives of adolescents and parents.  Teens frequently miss school, social events, activities with their families and may be at a heightened risk for psychological disorders, such as anxiety and depression.5  Of school-aged children and adolescents, 10 to 15 per cent report headaches that result in significant functional impairment.5

"There is a general lack of awareness that teens can suffer from migraines and the impairment that the symptoms can cause is often under-appreciated.  Accordingly, migraines in the adolescent population are under-diagnosed and under-treated," says Dr. Gladstone.  "This new indication for AXERT® represents an important clinical advancement in the treatment of migraines in adolescents.  Teenagers have a welcomed new option available for their migraine management and parents can be reassured by the data that supports the effectiveness and safety of AXERT®."

AXERT® is indicated for the acute treatment of migraine pain in adolescents 12 to 17 years of age who have had a history of migraine attacks with or without aura, usually lasting four hours or longer.1  Recommended dosing of AXERT® in adolescents and adults is the same, although choice of dose should be made on an individual basis: 6.25 mg or 12.5 mg, which may be repeated after two hours if the headache returns.1  The most common adverse events during treatment with AXERT® were dizziness, somnolence, nausea, vomiting, headache and paresthesia.1

ABOUT JOHNSON & JOHNSON INC.

AXERT® (almotriptan malate tablets) is an R&D product developed by Almirall, licensed to Johnson & Johnson Inc. by Almirall, S.A.  Johnson & Johnson Inc. is a member of the Johnson & Johnson Family of Companies, the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets.  Johnson & Johnson Inc. markets innovative products focusing on over the counter medicines, skin care, baby care, wound care, oral health and women's health.

References:


1 AXERT® Product Monograph.  Johnson & Johnson Inc.  2010.
2 Berenson, F.  et al.  Long-term, open label safety study of oral almotriptan 12.5 mg for the acute treatment of migraine in adolescents. Research Submission. American Headache Society.  2010.
3 Eiland LS., Hunt, MO.  The use of triptans for pediatric migraines.  Paediatr Drugs. 2010 Dec 1;12(6):379-89.
4 Lewis DW.  Almotriptan for the acute treatment of adolescent migraine.  Expert Opin Pharmacother.  2010.   Oct;11(14):2431-6.
5 Slater, S.  et al.  Effects of gender and age on pediatric headache.  Cephalagia, 2009.  Vol 29.  pp. 969-973.
6 Dooley JM, Gordon KE, Wood EP. Self-reported headache frequency in Canadian adolescents: validation and follow-up.  Headache. 2005 Feb;45(2):127-31


SOURCE Johnson

For further information:

Dana Singleton
Edelman
Dana.Singleton@edelman.com


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