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SANDOZ' DHE-45 SHOWS COMPARABLE EFFICACY TO GLAXO’s IMITREX

Executive Summary

SANDOZ' DHE-45 SHOWS COMPARABLE EFFICACY TO GLAXO's IMITREX for the treatment of migraine in a recent open-label trial of the agent, Sandoz said. Sandoz presented data on DHE-45 (dihydroergotamine mesylate) at the June 26-28 meeting of the American Association for the Study of Headache in Toronto. The company says that the data from the trial demonstrates the "similarities in the efficacy of 50- year old DHE-45" and Imitrex (sumatriptan), which is currently awaiting FDA approval. The study, involving 311 patients, was designed to assess the efficacy and safety of DHE-45 for treatment of migraine in the office setting, as opposed to the emergency room, Sandoz explained. According to a company press release, the results showed that pain disappeared or "was reduced to only mild pain" in 46% of the patients within 30 minutes of a 1 mg intramuscular injection of DHE- 45. After one hour, 72% of patients experienced pain relief. Adverse events, reported by 9% of patients, "were generally mild and short- lived," the release states. Explaining that "DHE-45 was shown...to be effective at a second dose administered after one hour, if required," the release suggests that DHE-45 might offer a therapeutic advantage over Imitrex. The release cites studies in New England Journal of Medicine and the Journal of the American Medical Association, claiming that the studies "found a second dose of sumatriptan at one hour to afford little additional benefit in patients who did not respond well to the first dose." In a 1991 presentation to FDA's Peripheral and Central Nervous System Drugs Advisory Committee, analysis of a Glaxo study showed that among patients receiving a second dose of Imitrex, 34% were free of pain at 60 minutes, versus 5% of patients on placebo ("The Pink Sheet" Oct. 28, 1991, p. 16). Seven other studies of DHE-45 were presented during the Toronto meeting, including studies of the use of the drug in treatment of menstrual migraine and postconcussion headache and a comparison of using DHE-45 with and without anti-nausea medication. * No study directly comparing the two migraine treatments has yet been undertaken. While Imitrex is pending approval at the FDA, Sandoz cannot conduct a comparative study in the U.S. However, the company is "exploring" the possibility of such a study overseas and in the U.S. once Imitrex receives approval. Imitrex currently is approved in several countries, including the U.K., Canada, Sweden and New Zealand. A Sandoz fact sheet for DHE-45 emphasizes the cost-effectiveness of the therapy: "At $7 per dose, DHE-45 offers clinicians a cost- effective option along with an efficacy comparable to emerging therapies." Noting that the treatment is rapid and non-sedating, Sandoz adds that the "cost/benefit of this compound may extend beyond its price" by promoting "a rapid return to normal functioning, which may serve to lessen the impact of worker absenteeism due to headache." DHE-45 was approved over 50 years ago and is indicated as a "therapy to abort or prevent vascular headaches, e.g., migraine, migraine variants, or so-called 'histaminic cephalagia' [cluster headache] when rapid control is desired or when other routes of administration are not feasible." Imitrex was recommended for approval for the treatment of migraine headaches but the advisory committee requested more data on cluster headaches. One drawback to DHE-45 use is the method of administration. Presently, DHE-45 is approved only as an intramuscular injection, Sandoz is "pursuing more convenient forms" of administration for DHE-45, the company said. An NDA was filed in 1990 for a nasal spray formulation of the drug ("The Pink Sheet" Aug. 5, 1991, T&G-17), and the company also has filed a supplemental NDA for a subcutaneous injection of DHE-45, which would enable patients to treat themselves at home without special training from a physician. * The FDA advisory committee reviewed Glaxo's subcutaneous version of Imitrex, which will be available in a pre-filled auto-injector. An oral version of the drug is available in Canada and was recently approved in the U.K. Glaxo filed an NDA for the oral form of Imitrex in December 1990. With an eye on the competition, Sandoz has begun a campaign to promote DHE-45 and to increase awareness about migraine headaches. The company's ad campaign is "proceeding [and] will get more aggressive" as Imitrex approaches the market, the company said.
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