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Industry: MEDICAL/PHARMACEUTICALS
FDA Also Approves MAXALT-MLT(TM), the First Migraine Medicine Available as
Orally Disintegrating Tablets That Patients May Take Without Water
WEST POINT, Pa., June 30 /PRNewswire/ -- Migraine sufferers now have a new way to treat their migraine headache the moment it strikes. Merck & Co., Inc. (NYSE: MRK) today announced that the U.S. Food and Drug Administration (FDA) approved Maxalt(R) (rizatriptan benzoate), a new medicine for the acute 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(TM) 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.
Studies Show Maxalt Provides Pain and Symptom Relief for Most Patients
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.
Maxalt-MLT: A Merger of Form and Function
Maxalt-MLT is the first migraine treatment that uses Zydis(R) (R.P. Scherer) technology, which uses saliva to break down the tablet in...