AstraZeneca, an international healthcare company, announced the results of a large placebo controlled study with 5 mg Zomig-ZMT (zolmitriptan) Orally Disintegrating Tablets showing efficacy as early as 30 minutes in the acute treatment of migraine with or without aura in adults. Efficacy rates (patient going from severe/moderate pain to mild/pain free) increased steadily up to 2 hours post treatment and remained superior to placebo. This early headache response was also sustained up to 24 hours in attacks treated with Zomig-ZMT 5 mg compared to attacks treated with placebo. Consistent with the high sustained headache response in this study, times to remedication and recurrence were also longer in the Zomig-ZMT group compared to placebo. In addition Zomig-ZMT 5mg was well tolerated with a low incidence of drug- related adverse events.

Zomig-ZMT is an orally disintegrating tablet, which was introduced in May 2001 providing an additional formulation to Zomig (zolmitriptan) Tablets. Zomig Tablets and Zomig-ZMT are indicated for the acute treatment of migraine with or without aura in adults. Zomig-ZMT is an orange flavored tablet that dissolves rapidly on the tongue, without the need for additional liquids. This formulation offers the added advantage of convenience for migraine sufferers. Phenylketonuric patients should be informed that Zomig-ZMT contains phenylalanine, a component of aspartame.

"The early and sustained response we observed with Zomig-ZMT 5 mg has important implications for migraine sufferers and the physicians who treat them," commented Egilius L.H. Spierings, M.D., Ph.D., Associate Clinical Professor of Neurology at Harvard Medical School "As the study shows, the sooner migraine sufferers can reduce the severity of their headache and find relief, the sooner they can return to normal everyday activities. A sustained headache response, as seen here, is a clinically important end point to achieve, because it means patients can go on with their day and not have to worry about recurrence and need for more medication.

Dr. Spierings and his colleagues conducted this, randomized, placebo-controlled, double blind, parallel group multicenter outpatient study in 33 US centers. This study included 670 patients treated with either Zomig-ZMT 5 mg orally disintegrating tablet or matching placebo for acute treatment of two moderate or severe migraine headaches. At 30 minutes, headache response (improvement in migraine headache intensity from severe or moderate to mild or pain free) was achieved in 17 per cent of attacks treated with Zomig-ZMT and 13 per cent of attacks in the placebo group.

At one hour, 41.1per cent of all attacks treated with Zomig-ZMT had a headache response, compared with 23 per cent for placebo. At two hours, the headache response increased to 59 per cent for Zomig-ZMT, compared with 31 per cent for placebo.

Twenty-four hours after initial treatment, 43 per cent of attacks treated with Zomig-ZMT had a sustained headache response compared to 16 per cent of placebo treated attacks. Sustained headache response was defined in the study as having a headache response at 2 hours after the initial dose and having no recurrence and no need for remedication through 24 hours.

Recurrence of headache was lower in patients treated with Zomig-ZMT than in the placebo group, with headache recurring in an average of 19 per cent of patients, compared to recurrence in 26 per cent of the patients receiving placebo. Average time to recurrence was between 10 and 12 hours for patients treated with Zomig-ZMT, compared to 4 to 4.5 hours for patients receiving placebo. Recurrence was defined as a response at 2 hours followed by an increase in headache intensity to moderate or severe pain within 2 to 24 hours after the initial dose.

When compared to placebo, the time to remedication was significantly longer in the Zomig-ZMT group, with times ranging from 13.25 to 21.5 hours, compared to 2.5 hours for the placebo group. A patient was considered to have remedicated if he or she took a second dose of trial medication or used escape medication between 2 and 24 hours after the initial dose of trial treatment.

Zomig-ZMT 5 mg was well tolerated. Most adverse events were mild or moderate in intensity and transient. Drug related adverse events occurred in 29.5 per cent of patients treated with Zomig-ZMT, compared to 11.4 per cent in the placebo group. The most common adverse events in the Zomig-ZMT group were tightness, dizziness, somnolence and paresthesia (tingling sensations).

According to the prescribing information, the most common side effects associated with taking Zomig include dizziness; tightness, pressure or pain in the neck, throat, or jaw; fatigue, tingling sensations, drowsiness; and nausea.

Zomig is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine.

Zomig is contraindicated for patients with uncontrolled hypertension, ischemic heart disease, or other significant underlying heart disease.

Zomig should not be taken by patients who have certain types of heart disease or uncontrolled high blood pressure. Very rarely, some people without recognized heart disease may have serious heart-related problems. Also patients who think they may have risk factors for heart disease such as smoking, high blood pressure, high cholesterol, or a family history of heart disease, or if they are pregnant, nursing, or taking medications, should talk to their healthcare provider.