Updated September 10, 2014.

Migraineurs and cluster headache sufferers who rely on triptans for relief, now have three formulas of Zomig available as the FDA has approved AstraZeneca's new Zomig (zolmitriptan) Nasal Spray, available in 5.0, 2.5, 1.0, and 0.5 mg dosages, for Migraine with or without aura. Zomig Nasal Spray joins the other two Zomig formulas, regular tablets and Zomig-ZMT orally disintegrating tablets.

With Migraine relief seen in clinical trials as early as 15 minutes, the nasal spray offers a fast acting treatment option for the32 million Americans who suffer from Migraine.

Results of a Zomig Nasal Spray pivotal trial showed significant response at 15 minutes with 11% of attacks treated with 5 mg and 11% of attacks treated with 2.5 mg, responding to treatment compared to 5.0% treated with placebo.1 Additionally, a significantly greater headache response was achieved at two hours for the 5 mg dose of Zomig Nasal Spray compared with placebo, with a response rate of 69%, compared with 31% for placebo.1 In 49.4% of the 5 mg Nasal Spray patients, 24 hour head painrelief was realized with only one dose, as compared to 13.9% treated with placebo.

The efficacy and tolerability of Zomig Nasal Spray in the acute treatment of Migraine were evaluated in a multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group study conducted at 42 centers in 11 countries. A total of 1,547 patients were randomized to receive either Zomig Nasal Spray, Zomig 2.5mg tablets or placebo for the treatment of three moderate or severe migraine attacks. The primary efficacy measure was head painresponse at two hours following treatment.

Head painresponse was defined as a reduction in pain from moderate or severe at baseline to mild or none.

Zomig Nasal Spray was well tolerated in all treatment groups, with the majority of adverse events short in duration and of mild or moderate intensity. Among patients treated with Zomig Nasal Spray 5 mg, the most common adverse events were:

• taste disturbance (21.2% compared to 3.1% in the placebo group)
• paresthesia (abnormal touch sensation; 9.7%. vs. 5.7% in the placebo group)
• hyperesthesia (increased sensitivity to touch; 5.1% compared to 0% in the placebo group)
• somnolence (sleepiness, 3.8% compared to 1.8% in the placebo group)
• dizziness (3.0% vs. 4.4% for placebo).

Less than 1% of patients withdrew from clinical trial due to taste disturbance. Adverse events were consistent with the known pharmacological effects of the triptan class of medications.

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 Migraine preventive treatment 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. Phenylketonuric patients should be informed that ZOMIG-ZMT contains phenylalanine, a component of aspartame.

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.

Resources:

AstraZeneca News Room: "FDA Approves New ZOMIG® (zolmitriptan) NASAL SPRAY Formulation."
FDA Approves Third Zomig (zolmitriptan) Product
Migraineurs and cluster headache sufferers who rely on triptans for relief, now have three formulas of Zomig available as the FDA has approved AstraZeneca's new Zomig (zolmitriptan) Nasal Spray, available in 5.0, 2.5, 1.0, and 0.5 mg dosages, for Migraine with or without aura. Zomig Nasal Spray joins the other two Zomig formulas, regular tablets and Zomig-ZMT orally disintegrating tablets.

With Migraine relief seen in clinical trials as early as 15 minutes, the nasal spray offers a fast acting treatment option for the32 million Americans who suffer from Migraine. Results of a Zomig Nasal Spray pivotal trial showed significant response at 15 minutes with 11% of attacks treated with 5 mg and 11% of attacks treated with 2.5 mg, responding to treatment compared to 5.0% treated with placebo.1 Additionally, a significantly greater headache response was achieved at two hours for the 5 mg dose of Zomig Nasal Spray compared with placebo, with a response rate of 69%, compared with 31% for placebo.1 In 49.4% of the 5 mg Nasal Spray patients, 24 hour head painrelief was realized with only one dose, as compared to 13.9% treated with placebo.

The efficacy and tolerability of Zomig Nasal Spray in the acute treatment of Migraine were evaluated in a multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group study conducted at 42 centers in 11 countries. A total of 1,547 patients were randomized to receive either Zomig Nasal Spray, Zomig 2.5mg tablets or placebo for the treatment of three moderate or severe migraine attacks. The primary efficacy measure was head painresponse at two hours following treatment. Head painresponse was defined as a reduction in pain from moderate or severe at baseline to mild or none.

Zomig Nasal Spray was well tolerated in all treatment groups, with the majority of adverse events short in duration and of mild or moderate intensity. Among patients treated with Zomig Nasal Spray 5 mg, the most common adverse events were:

• taste disturbance (21.2% compared to 3.1% in the placebo group)
• paresthesia (abnormal touch sensation; 9.7%. vs. 5.7% in the placebo group)
• hyperesthesia (increased sensitivity to touch; 5.1% compared to 0% in the placebo group)
• somnolence (sleepiness, 3.8% compared to 1.8% in the placebo group)
• dizziness (3.0% vs. 4.4% for placebo).

Less than 1% of patients withdrew from clinical trial due to taste disturbance. Adverse events were consistent with the known pharmacological effects of the triptan class of medications.

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 Migraine preventive treatment 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. Phenylketonuric patients should be informed that ZOMIG-ZMT contains phenylalanine, a component of aspartame.

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.

Resources:

AstraZeneca News Room: "FDA Approves New ZOMIG® (zolmitriptan) NASAL SPRAY Formulation."