~ 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
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.
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
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