Home » Drug Information » FDA Approved Drugs » 2001
Medical Areas: Neurology | Family Medicine
View By:YearCompanyConditionsTherapeutic AreasDrug Names
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved February 2001
Treatment Area: Migraine
Zomig-ZMT is an orally disintegrating tablet that has been
approved for treatment of acute migraines in adults. The tablet has
a pleasant orange flavor and dissolves quickly on the tongue. This
easy delivery method makes the product convenient to take at
Zomig-ZMT has a novel, dual-action pharmacological profile that
has demonstrated both peripheral and central activity in the brain,
working together to provide rapid, long-lasting relief of migraine
Migraine is a common disorder worldwide and estimates suggest
that 10 to 15 percent of the population in developed countries are
affected at some time during their lives. The prevalence of
migraine reaches a peak during sufferers' most productive
years, between the ages of 25 and 55. The condition often causes
disability and adversely affects quality of life.
The effectiveness of Zomig-ZMT (zolmitriptan) as a treatment for
acute migraine was established in five randomized, double-blind,
placebo-controlled trials. The first was conducted in a clinical
setting, while the other four were outpatient studies. Adult
subjects received Zomig-ZMT in dosages of 1 mg, 2.5mg, or 5mg. They
were instructed to administer the drug when suffering from moderate
to severe migraine pain.
Subjects were assessed one, two, and four hours after dosing.
Response was defined as reduction in severity of headache pain from
moderate or severe, to mild or no pain. In all studies, subjects
who received the two higher doses of Zomig-ZMT achieved a
significantly greater response compared to those receiving the
lowest dosage or placebo. Of the two studies evaluating the 1 mg
dosage, only one reported subjects in the drug group achieving a
significantly greater response than those in the placebo group.
(from Zomig-ZMT Prescribing Information)
Trials demonstrated efficacy of Zomig-ZMT to be significant
within one hour of dosing, with some patients experiencing relief
within 30 minutes. One tablet provided relief up to 24 hours in the
majority of subjects.
Adverse events associated with the use of zolmitriptan may
include (but are not limited to) the following:
- Chest pain
- Tightness in throat
- Feelings of tingling, heat, or pressure
Mechanism of Action
Zomig-ZMT (zolmitriptan) is an oral selective
5-hydroxytryptamine (5-HT) receptor agonist that binds to human
recombinant 5-HT and 5-HT receptors. It is thought that migraine
symptoms are due to local cranial vasodilatation and/or to the
release of sensory neuropeptides through nerve endings in the
trigeminal system. The therapeutic effects of zolmitriptan are most
likely due to the agonistic effects at the 5-HT recptors on
intracranial blood vessels and sensory nerves of the trigeminal
system, which result in cranial vessel constriction and inhibition
of pro-inflammatory neuropeptide release.
After zolmitriptan is absorbed through oral administration, its
peak plasma concentrations occur in two hours. (from Zomig-ZMT