Sumatriptan Nasal Spray for Migraine
December 15, 1997 3 minutes read
Sumatriptan Nasal Spray for Migraine
By William T. Elliott, MD, and James Chan, PharmD, PhD
Glaxo wellcome has introduced sumatriptan, its widely used migraine medication, in a new formulation as a nasal spray. The drug has been available in a self injectable kit and in an oral form for several years. The nasal spray allows for rapid absorption of the drug in levels comparable to the oral tablets.
Sumatriptan is a selective agonist of vascular serotonin (5-HT1) receptors, which are present on cranial arteries and in the vasculature of the dura mater. Activation of these receptors causes vasoconstriction, among other effects.
Indication
Sumatriptan nasal spray is indicated for the acute treatment of migraine attacks with or without aura in adults.
Potential Advantages
Compared to the subcutaneous and oral forms of sumatriptan, the nasal spray provides an intermediate route of administration. Nasal sumatriptan provides maximum plasma concentration at 1-1.5 hours compared to about 2.5 hours during a migraine attack for the oral formulation.1 There are no published trials between the oral or nasal formulation. The data do, however, suggest that the onset of pain relief may be slightly sooner. The nasal formulation may be more suitable for patients experiencing nausea and vomiting. In addition, decreased gastrointestinal motility during a migraine attack may interfere with orally administered drug.2 Chest, jaw, and neck tightness common with the injection are reported to be infrequent with the nasal formulation.3,4
Potential Disadvantages
The nasal formulation has a lower response rate and a slower onset of action than the subcutaneous formulation. The overall response rate for the subcutaneous formulation is 70-80% (in 1 hour) compared to 55-64% (at 2 hours) for the nasal formulation.2,3 Dose-related taste disturbance (14-25%) is unique to the nasal formulation. The nasal formulation shares the same warnings, contraindications, potential for drug interactions, and short half-life as other formulations of sumatriptan, including a contraindication for patients with ischemic heart disease or vasospastic coronary artery disease.
Dosing Information
Sumatriptan nasal spray is supplied in 5 mg or 20 mg as unit dose spray devices. More patients respond to the 20 mg dose than the 5 or 10 mg dose, although the dose should be individualized. The 5 and 20 mg doses are administered as a single spray in one nostril. A 10 mg dose may be administered as a 5-mg dose in each nostril. If headache returns, the dose may be repeated once after two hours. Doses above 20 mg generally do not provide any greater effect than 20 mg.3
Comments
Sumatriptan is a potent agonist of vascular serotonin receptors with affinity for 5HT1D subtype.3 The nasal formulation was approved by the FDA based on several placebo trials, none of which has been published. There are also no comparative trials between the nasal formulation and either the oral or subcutaneous formulations.
Migraine headache affects 8-12% of the general adult population, with greater prevalence in women. The one-year prevalence is 3-6% in men and 13-18% in women, with the highest between the ages of 25 and 55. Pharmacologic treatment of acute migraine attack includes analgesics, nonsteroidal antiinflammatory agents, ergotamine products, intranasal butorphanol, and sumatriptan. Sumatriptan has become a mainstay in the pharmacologic management of migraine headaches and may be associated with health-related quality of life improvements.5
Although effective for some patients, sumatriptan is not a panacea for the treatment of migraine. About 35-45% of patients who initially responded develop a recurrence of their headaches within 24 hours.6,7 A small number of patients may develop a sumatriptan dependency, with daily headaches requiring daily use of the drug. Preliminary data suggest that those patients who have previously abused other antiheadache drugs are at greater risk.8
Clinical Implications
For those patients who are responsive to sumatriptan, the nasal spray offers an alternative to injection for patients who require rapid relief of migraine headache. The cost for the nasal spray is about $15 per dose (5 mg or 20 mg) compared to $30 per dose (6 mg) for the injection and $9 and $15 for the 25 mg and 50 mg tablets, respectively.
References
1. Imitrex Tablet product information. Glaxo Wellcome, Inc. June 1995.
2. Plosker GL, et al. Drugs 1994;47:622-651.
3. Imitrex Nasal Spray product information. Glaxo Wellcome Inc. September 1997.
4. Imitrex Injection product information. Glaxo Wellcome Inc. May 1996.
5. Coukell AL, et al. Pharmacoeconomics 1997;11: 473-490.
6. Cady RK, et al. JAMA 1991;265:2831-2835.
7. Goadsby PJ, et al. Lancet 1991;338:782-783.
8. Ferrari MD, et al. Curr Opin Neurol 1995;8:237-242.
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