About the Drug-
the First Migraine Medicine Available as Orally Disintegrating Tablets
that Patients May Take Without Water!
Migraine sufferers now have a new way to treat their migraine headache
the moment it strikes. MAXALT® (rizatriptan benzoate), the newest
abortive treatment of migraine with or without aura in adults. MAXALT
is the first and only migraine medicine available in both conventional
tablets and convenient MAXALT-MLT tablets, which disintegrate
within seconds on the tongue without liquids.
The FDA approval of MAXALT was based on four placebo-controlled clinical
studies of MAXALT 10 mg (1,167 patients) and 5 mg tablets (977 patients).
In these studies, approximately seven in 10 patients who took MAXALT
10 mg reported pain relief at two hours; six in 10 patients who took
MAXALT 5 mg reported pain relief at two hours.
"A migraine is like a tornado. It attacks fast, usually without warning,
and wreaks havoc regardless of what's going on in your life at that
moment," says Stephen Silberstein, M.D., director of the Jefferson
Headache Clinic in Philadelphia and a clinical investigator for MAXALT.
"MAXALT is effective in relieving migraine pain and symptoms. In addition,
patients can take the MAXALT-MLT easily and discreetly, even in the
middle of a movie or a meeting."
MAXALT-MLT orally disintegrating tablets and conventional MAXALT
tablets will both be available in 10 mg and 5 mg strengths; there
is evidence that the 10 mg dose may provide a greater effect than
the 5 mg dose.
About the Dose-
Clinical studies show that MAXALT provided high rates of pain relief
compared to placebo. Across the studies, MAXALT 10 mg relieved migraine
pain for 67 percent to 77 percent of patients by two hours, and MAXALT
5 mg relieved migraine pain for 60 percent to 63 percent of patients
by two hours. MAXALT also relieved the other migraine symptoms: nausea,
photophobia and phonophobia.
Studies Show MAXALT Provides Pain and Symptom Relief for Most Patients
MAXALT-MLT is the first migraine treatment that uses Zydis® (R.P.Scherer)
technology, which uses saliva to break down the tablet in seconds,
enabling patients to take the mint-flavored tablet without water.
MAXALT is a medication used only for the treatment of migraine attacks
in adults when a clear diagnosis is established. It should not be
used to treat headaches that could be caused by other, more serious
conditions. Patients should not take MAXALT if they have had a serious
allergic reaction to MAXALT or any of its ingredients, have uncontrolled
high blood pressure, heart disease or history of heart disease, or
symptoms or findings consistent with heart disease. Patients with
risk factors for heart disease require a cardiovascular evaluation.
MAXALT should not be used within 24 hours of treatment with another
drug in this class or with ergotamine-type medicines, or within 14
days of taking a monoamine oxidase (MAO) inhibitor.
MAXALT is Well Tolerated-
In a safety database of more than 3,700 patients who received single
or multiple doses of MAXALT, MAXALT was generally well tolerated.
Side effects were usually mild, temporary and dose related. In studies,
the most commonly reported side effects were: dizziness, sleepiness,
tiredness, fatigue, and pain or pressure (e.g., in the chest or throat).
MAXALT is a highly selective 5-HT1B/1D agonist. Rizatriptan, the
active ingredient in MAXALT, resulted from Merck's search for an oral
anti-migraine medication that was a well absorbed oral 5-HT1B/1D agonist.
Treatment with MAXALT is thought to relieve migraine pain and symptoms
- constricting swollen blood vessels around the brain;
- inhibiting the release of neuropeptides that cause further swelling
of those blood vessels; and,
- reducing the transmission of pain signals from sensory nerves to