Posted by Bob Johnson (12.19.49.2) on May 18, 2000 at 11:56:19:
AAN: Axert (almotriptan malate) as effective as Imitrex (sumatriptan) with fewer side effects
SAN DIEGO, CA -- May 5, 2000 -- Researchers this week presented results of a clinical study that showed that Axert(TM) (almotriptan malate tablets), a new selective serotonin 5-HT receptor agonist, had similar efficacy to Imitrex(R) tablets (sumatriptan), the current leading drug in its class. Research also showed that Axert was less likely to cause the side effect of chest pain, as compared with sumatriptan. Axert is being studied by Pharmacia Corporation for the acute treatment of migraine with or without aura in adults. The results were presented at the Annual Meeting of the American Academy of Neurology (AAN).
In a double-blind study, 1,173 adult patients received a single dose of either Axert 12.5 mg (591 patients) or Imitrex 50 mg (582 patients) at the onset of a migraine attack. Both treatments provided pain relief at two hours after drug administration (58 percent Axert vs 57 percent Imitrex). Similar pain relief was also observed between the treatment groups at 30 minutes and one hour.
Fifteen percent of patients treated with Axert experienced side effects compared with 19 percent of Imitrex patients. A significant difference was reported in the number of patients reporting chest pain symptoms: 0.3 percent of the group treated with Axert and 2.2 percent of the Imitrex group. The most frequently-reported side effects, each of which was reported by less than 3.5 percent of patients in either group, were nausea, dizziness and sleepiness.
"These results are significant because they show that Axert relieved the devastating pain of migraine," said Egilius L.H. Spierings, M.D., Ph.D., principal investigator for Axert and a pharmacologist, neurologist and headache specialist associated with Brigham and Women's Hospital in Boston and Harvard Medical School.
In another study, which was an open-label six-month trial to study long-term safety, 582 adult patients took Axert to relieve the pain of a total of 10,605 migraine attacks. At two hours after administration, patients experienced pain relief in 76 percent of the attacks. Patients reported being pain free at two hours in 49 percent of attacks. In 1,718 migraine relapses that occurred within 24 hours, taking a second dose of Axert resulted in pain relief in 86 percent and freedom from pain in 59 percent at two hours. The most frequently reported drug-related adverse events were nausea (3 percent) and dizziness (2 percent); adverse events led to discontinuation of treatment in 36 patients (6 percent).
Pharmacia Corporation plans to market Axert in the United States under a licensing agreement with the drug's developer, Almirall Prodesfarma, S.A., Spain. Pharmacia submitted a new drug application for Axert with the U.S. Food and Drug Administration on December 17, 1999. Almotriptan currently is approved in Spain.