Results from two studies evaluating Zomig Nasal Spray, an investigational new drug from AstraZeneca, were presented at the 55th annual meeting of the American Academy of Neurology. The studies surveyed patient satisfaction with Zomig Nasal Spray during short- and long-term treatment. Results from the survey show the majority of patients in these groups reported good or excellent satisfaction with Zomig Nasal Spray 5mg.
Patients taking the 5mg dose were asked to rate their satisfaction with Zomig Nasal Spray as excellent, good, fair, or poor. Satisfaction rates, were higher in the long-term treatment phase, with 70 per cent of patients reporting the treatment to be good or excellent, compared to 58 per cent of the patients in the short-term treatment phase.
"Migraine can have a considerable impact on patient's lives," says Dr. Susan Abu-Shakra, AstraZeneca Associate Medical Director and a migraine sufferer. "It is essential that a migraine sufferer be satisfied with their medication, so they are more likely to treat their attack early."
Nasal Sprays may offer an alternative for patients who experience nausea or vomiting in conjunction with their migraine. The New Drug Application (NDA) for Zomig Nasal Spray is currently under review at the U.S. Food and Drug Administration (FDA).
Study results were based on the evaluation and analysis of two clinical trials, which evaluated efficacy and safety, of Zomig Nasal Spray during short- and long-term treatments. In the short-term randomized, placebo-controlled study, 235 patients were treated with Zomig Nasal Spray 5 mg for up to three moderate or severe migraine attacks (for a total of 603 attacks). The long-term extension study, evaluated 783 patients (including patients randomized to different treatments than in the short-term study) who used Zomig Nasal Spray 5mg to treat 10,507 migraine attacks of any baseline severity over the course of one year.
Following treatment with Zomig Nasal Spray, patients had an option of rating their migraine treatment by using a 4-point scale of excellent, good, fair or poor. The majority of patients rated their satisfaction with Zomig Nasal Spray as good or excellent. Fifty-eight percent (58 per cent) of those in the short-term study rated their level of satisfaction as high, with satisfaction rates increasing significantly during long-term treatment, to 70 per cent.
The most common adverse events reported in these studies were unusual taste, paresthesia, hyperesthesia and dizziness. Withdrawals due to adverse events were minimal, with 1.3 per cent in the short-term study, including only 0.8 per cent withdrawing due to unusual taste. In the long-term study, only 1.9 percent withdrew due to adverse events, for which unusual taste constituted only 0.4 per cent. Overall, willingness to continue treatment was not affected by the occurrence of unusual taste across all study phases.
Zomig (zolmitriptan) is available in 2.5mg and 5mg dosages of a tablet as well as an orally disintegrating tablet Zomig-ZMT (zolmitriptan). Phenylketonuric patients should be informed that Zomig-ZMT contains phenylalanine, a component of aspartame.
Zomig Tablets and Zomig-ZMT Orally Disintegrating Tablets are indicated for the acute treatment of migraine with or without aura in adults. Zomig is not intended to prevent attacks from happening but to relieve pain regardless of when the attack occurs.
Zomig is contraindicated for patients with uncontrolled hypertension, ischemic heart disease, or other significant underlying heart disease. In addition, Zomig should not be administered to patients who are hypersensitive to zolmitriptan or any of the inactive ingredients of Zomig. Zomig is not intended for the prophylactic therapy of migraine or for the use of the management of hemiplegic or basilar migraine.
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.
The most common side effects associated with taking oral Zomig include dizziness; tightness, pressure or pain in the neck, throat, or jaw; fatigue; tingling sensations; drowsiness; and nausea.