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| |  New Drug Application Filed for ZOMIG Antimigraine Treatment WILMINGTON, Del.-- Jan. 16, 1997-- Zeneca Inc. today announced that a New Drug Application (NDA) has been filed with the Food and Drug Administration for ZOMIG(TM) (zolmitriptan), a newly developed oral agent for the acute treatment of migraine. Zeneca has also recently announced submission for regulatory approval of ZOMIG in Europe. ZOMIG is a novel, dual action, second generation selective serotonin agonist. In preclinical studies, ZOMIG demonstrates both peripheral and central activity in the brain. In addition to the peripheral action of constricting cerebral blood vessels, ZOMIG also acts centrally at the trigeminal nucleus within the brain stem. The ZOMIG NDA data from eight clinical trials involving more than 2,700 patients was used to assess its safety and efficacy. In the five placebo-controlled studies, ZOMIG consistently provided headache relief two hours posttreatment at a statistically significant rate greater than placebo. Over a 24-hour period, ZOMIG was shown to be more effective than placebo in providing relief from moderate or severe pain and considerably reduced the use of other pain medications. Long-term study results revealed that ZOMIG had similar results in treating multiple migraine attacks for up to one year. Additionally, the antimigraine effects of ZOMIG are not affected by age, gender, weight, menstrual cycle, the presence of aura, or duration of attack. Based on a safety database of more than 3,000 people, ZOMIG was well-tolerated. Adverse events reported by patients treated with ZOMIG were mostly of mild or moderate intensity and did not require treatment; the most common included: asthenia (lack of energy), nausea, dizziness, somnolence (drowsiness), and paresthesia (feelings such as tingling, numbness, or itching). "ZOMIG is another important step for Zeneca in its commitment to becoming a leader in the medical treatment of the central nervous system," said Paul Plourde, MD, Executive Clinical Director of Clinical Research at Zeneca Pharmaceuticals. Migraine is the most common neurological disease in developed countries, with an estimated 23 million sufferers in the US. The market for its treatment in both the US and worldwide is growing rapidly. In 1995, prescription antimigraine treatments in the US accounted for more than $397 million in sales, an increase of more than 30 percent from 1994. The worldwide migraine treatment market is expected to reach approximately $2.3 billion by the year 2000. The company currently markets DIPRIVAN(R) (propofol) Injectable Emulsion, a sedative hypnotic for the induction and maintenance of anesthesia and monitored anesthesia care, and recently submitted regulatory packages in the US and UK for SEROQUEL(TM) (quetiapine), a new oral atypical antipsychotic medication discovered and developed by Zeneca Pharmaceuticals for the management of the manifestations of psychotic disorders. Approximately 20 percent of the Zeneca Pharmaceuticals' research and development resources are devoted to discovering and bringing to market innovative central nervous system disorder treatments. In the US, Zeneca is a $2.8 billion bioscience business with approximately 6,000 employees at 53 locations in 24 states. Zeneca Inc. is a wholly-owned subsidiary of the UK-based Zeneca Group PLC (NYSE:ZEN), a major $7.6 billion international bioscience business engaged in research; development; manufacture and marketing of ethical (prescription) pharmaceutical, agricultural and specialty chemical products; and the supply of health care services.
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