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IHC: Zomig (Zolmitriptan) Nasal Spray Offers Effective, Convenient Alternative For Migraine
NEW YORK, NY, -- June 29, 2001 -- ZomigŪ (zolmitriptan) 5 mg Nasal Spray combines fast acting, highly effective relief with an excellent tolerability profile allowing patients to treat their migraine attacks anytime and anywhere.
"In achieving significant onset of relief within 15 minutes, Zomig Nasal Spray can offer patients a highly effective and convenient migraine therapy with a rapid onset of action, and provides doctors with a real alternative treatment option to oral tablets or subcutaneous injection", explained Werner Becker, MD from the Foothills Medical Centre, Calgary, Canada at an AstraZeneca satellite symposium during the International Headache Conference in New York (29 June - 2 July 2001).
Migraine is a highly variable, chronic disorder with attacks occurring intermittently and often unexpectedly. The clinical features of this disabling neurological condition vary from attack to attack and over time, both among and within individual migraine sufferers. This means that a range of therapeutic options is necessary to suit the needs and preferences of patients.
Oral formulations of migraine treatments are most commonly used. However, migraine attacks are often accompanied by nausea and vomiting, and in these circumstances, a non-oral dosage form may be preferred. Rapid onset of pain relief is rated by patients as one of the most important attributes of migraine therapy(1). Although subcutaneous injections are an alternative for patients with severe migraine or for those who require a particularly rapid onset of action, many patients fear injections and are reluctant to
self-inject(2,3).
"A formulation which provides rapid relief without the need to self-inject is needed to improve migraine management - Zomig Nasal Spray has been developed to fill this need", continued Dr Becker.
Pharmacokinetic studies show that zolmitriptan nasal spray is absorbed more rapidly than the oral tablet, with active drug detected in the plasma five minutes post-dose and 50 per cent of Cmax achieved within 15 minutes. Positron emission tomography (PET) imaging and pharmacokinetic profiling data suggest that up to 30 per cent of the administered dose of zolmitriptan nasal spray is absorbed directly across the nasal mucosa, with the remainder of the dose passing down the oesophagus and absorbed from the gastrointestinal tract. This high level of nasopharyngeal absorption may result in a more rapid onset of headache relief.
In a randomized, double-blind, double-dummy, multicentre, placebo-controlled clinical study, the efficacy and tolerability of zolmitriptan nasal spray were compared with both placebo and zolmitriptan 2.5 mg. A total of 1547 patients were randomized to one of four doses of zolmitriptan nasal spray (0.5 mg, 1.0 mg, 2.5 mg or 5.0 mg), zolmitriptan 2.5 mg oral tablet or placebo for the treatment of up to three moderate or severe migraine attacks.
The primary endpoint for the study was headache response at two-hours, defined as a reduction in migraine pain from moderate or severe at baseline to mild or none, at two hours post-dose. Secondary endpoints further evaluated headache response at 15, 30, 45 and 60 minutes post-dose and at four hours post-dose.
All doses of zolmitriptan nasal spray provided significantly greater two-hour headache response versus placebo. Furthermore, the 5.0 mg dose of the nasal spray also demonstrated a statistically higher headache response than the 2.5 mg oral tablet at all time points up to four hours. Response rates at two hours were 41 per cent, 55 per cent, 59 per cent and 70 per cent for zolmitriptan nasal spray 0.5, 1, 2.5 and 5 mg respectively, compared with 30 per cent for placebo (all p<0.001) and 61 per cent for the oral 2.5 mg tablet (p<0.05 for 5mg nasal spray dose only).
Most importantly, the speed of onset of zolmitriptan nasal spray 5 mg was rapid. It was found to be significantly more effective than the oral tablet for headache response by 15 minutes and at all subsequent time points analysed up to two hours, and has equivalent efficacy at four hours.
High efficacy was also seen in the subgroup of patients with pre-treatment nausea, with 68 per cent of patients receiving zolmitriptan 5 mg nasal spray achieving a two-hour response compared to 31 per cent of patients receiving placebo and 57 per cent for the oral tablet.
All doses of zolmitriptan nasal spray were well tolerated with the majority of adverse events being of short duration, of mild or moderate intensity and resolved without medical intervention.
Zolmitriptan is a 5-HT1B/1D receptor agonist that is highly effective for the acute treatment of migraine(4,5). Zomig oral tablets and Zomig Rapimelt (an orally dispersible formulation that can be taken without the need for liquids) are widely available throughout Europe and North America. Zomig Nasal Spray is not yet commercially available. A marketing authorisation application has been submitted in Europe.
References:
(1) MacGregor E. Shouting Out From The Maze. Oral Presentation, EFNS 2000, Copenhagen.
(2) Loder E. Routes of Administration of Acute Migraine Therapy. Headache 1999; 39 (suppl 2): S35-39.
(3) Rapoport AM, Sheftell FD. Intranasal medications for the treatment of migraine and cluster headache. CNS Drugs 1997; 7: 37-46.
(4) Rapoport AM, Ramadan NM, Adelman JU et al. Optimising the dose of zolmitriptan (Zomig, 311C90) for the acute treatment of migraine. A multicenter, double-blind, placebo-controlled, dose range-finding study. The 017 Clinical Trial Study Group. Neurology 1997; 49:1210-18.
(5) Solomon GD et al. Clinical efficacy and tolerability of 2.5 mg zolmitriptan for the acute treatment of migraine. The 042 Clinical Trial Study Group. Neurology 1997; 49:1219 -25.
SOURCE: AstraZeneca Pharmaceuticals
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