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10/3/2003

Zolmitriptan to Be Available in Nasal Spray

Cheryl Thompson

A migraine remedy that patients can spray in their nose rather than ingest at the onset of the often-debilitating headache was approved for marketing this week by the Food and Drug Administration.

Zomig nasal spray, delivering 5 mg of zolmitriptan per spritz, joins AstraZeneca's product line of 2.5-mg and 5-mg tablets and orally disintegrating tablets for the acute treatment of migraine in adults.

The company said that, as of Jan. 1, the entire product line would be distributed by MedPointe Inc., a specialty pharmaceuticals company.

According to the labeling for zolmitriptan nasal spray, the recommended dose is one spray into a nostril. If the migraine returns, a second spray may be given two hours after the first. Because the spray device delivers a single 5-mg dose, patients—such as persons with moderate to severe impairment of liver function—needing a lower dose of zolmitriptan must use one of the tablet formulations.

As with the oral tablets, no more than 10 mg of zolmitriptan—equivalent to two doses of the nasal spray—should be taken in a 24-hour period.

The contraindications to the use of zolmitriptan are the same as for other serotonin type 1-receptor agonists, known colloquially as triptans.

According to the company, patients who used zolmitriptan in the clinical studies of the nasal spray product complained most frequently about taste disturbance (21.2 percent), abnormal touch sensation (9.7 percent), increased sensitivity to touch (5.1 percent), and sleepiness (3.8 percent). 

Zomig nasal spray will be available from MedPointe in boxes containing six single-use units.