New Imigran Formulation Shown to Start Working in as Fast as 20 Minutes

Main Category: Headache / Migraine
Article Date: 21 Sep 2004 - 10:00 PDT

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Imigran 100mg tablets the first triptan tablet to demonstrate 20 minute onset of relief

Results from a new study presented today at The 15th Migraine Trust International Symposium demonstrate that the new fast disintegrating, 100mg tablet formulation of Imigran™ (sumatriptan succinate) delivered onset of relief in as fast as 20 minutes. Until now, clinical studies for oral triptans, including Imigran, showed onset of relief in as early as 30 minutes.1-5

The results come from a pooled analysis of two pivotal studies showing that a 100 mg dose of Imigran provided onset of relief in as early as 20 minutes, and from 30 minutes with a 50 mg dose. In the European study, patients taking Imigran 100mg, even when it was taken after the pain became moderate to severe, experienced onset of relief in as early as 17 minutes. By two hours, 72 percent of patients taking 100 mg experienced pain relief.

"Every minute of relief counts when a patient suffers from a migraine attack that can significantly impact one's quality of life and drastically interrupt their daily lives," said Reto Agosti, MD, a neurology director at KopfwehZentrum Hirslanden Zürich, Switzerland. "Finding a therapy that effectively alleviates pain and works quickly is critical. These data show that Imigran does just that, offering promising news for migraine sufferers."

Migraines are a neurobiological disorder affecting 10-15 percent of the adult population in developed countries each year. Without treatment, migraines can last from 4 to 72 hours, and the severity of symptoms can result in missed days from work, lost time with family and friends and disruption in daily activities.6

Study Results

Patients taking Imigran 100mg experienced onset of relief in as early as 17 minutes in the European study (5 percent vs. 2 percent for placebo) and 25 minutes in the U.S./Canadian study (17 percent vs. 12 percent for placebo). Pooled results demonstrated an onset of relief in as early as 20 minutes for the 100mg formulation (6 percent vs. 4 percent for placebo). By two hours, 72 percent of patients taking 100 mg experienced pain relief in both studies. Imigran 50mg delivered an onset of relief in as early as 30 minutes in the European study (18 percent vs. 11 percent for placebo) and 50 minutes in the U.S./Canadian study (30 percent vs. 24 percent for placebo). Pooled results showed an onset of relief in as early as 30 minutes for the 50 mg formulation (19 percent vs. 14 percent for placebo). The percentage of patients on 50mg reporting pain relief within two hours was 65 percent in Europe and 69 percent in the U.S./Canada. The pooled data demonstrated 67 percent of patients on 50mg reported pain relief within two hours.

About the Study

Two double-blind, placebo-controlled, single-attack outpatient studies were conducted at 153 centers in the United States and Canada, and 119 centers in Europe. A total of 2,696 patients, ages 18-65 years old, were enrolled (1,366 in the U.S. and Canada; 1,330 in Europe). Patients were randomised to receive Imigran 100mg, 50mg or placebo and asked to report elapsed time to relief (mild or no pain) using a stopwatch device. The primary endpoint - time to onset of relief - was predefined as the earliest minute at which a significant difference was achieved and then the statistical difference was maintained through two hours. Pain relief was described as the reduction of moderate/severe pain to mild/no pain.

The most commonly reported adverse events were nausea (2-4 percent), paraesthesia (1-3 percent), dizziness (1-2 percent) and somnolence (0-2 percent). All other adverse events were reported by, at most, 1 percent of all subjects.

About Fast Disintegrating Tablet Formulation of Imigran

The new fast disintegrating tablet formulation of Imigran has been approved for use in Sweden, Finland, Germany, The Netherlands, Norway, Switzerland, United Kingdom, Estonia and the United States for the treatment of migraine in adults with or without aura.

The originally-marketed sumatriptan tablets disintegrate by the conventional mechanism of surface erosion involving the outer surface of the tablet wearing down in the stomach, which leads to the release of the medication and absorption in the body. Gastric motility - the natural movement of the gastrointestinal tract - helps in this process. However, migraine attacks frequently reduce gastric motility, which may delay the absorption of medication and, therefore, delay onset of pain relief.7

The new fast disintegrating form of Imigran swells and breaks apart in the stomach after being swallowed with water.

This method of disintegration and dispersion makes the new formulation less reliant on gastric motility than traditional oral tablets.8 The results of the current studies indicate that this may result in a significantly faster onset of pain relief.

About GlaxoSmithKline

GlaxoSmithKline was the first company to develop a treatment specifically for migraine. With more than 12 years of migraine therapy innovation, GlaxoSmithKline is the only company to offer a full family of treatment options including four sumatriptan formulations - traditional oral tablet, fast disintegrating tablet, nasal spray and subcutaneous injection. Sumatriptan has been used to treat more than 500 million attacks, which is equivalent to treating a migraine attack each second for the past 12 years.

As one of the world's leading research-based pharmaceutical and health care companies, GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

NOTE TO EDITORS:

About Imigran

If the diagnosis is migraine, then migraine-specific prescription therapies, like Imigran™ (sumatriptan succinate), are available to treat the pain and associated symptoms of migraine without causing significant sedation. Imigran was the first prescription drug in a class of drugs called triptans to receive regulatory agency approval for the acute treatment of migraine in adults. It should only be used where a clear diagnosis of migraine has been established.

Full prescribing information is available upon request.

References

1 Lines C, Visser WH, Vandormael K, et al. Rizatriptan 5 mg versus sumatriptan 50 mg in the acute treatment of migraine [abstract]. Headache 1997; 37:319-320.

2 Lines C, Visser WH, Vandormael K, et al. A comparison of low-dose rizatriptan (Maxalt) 5 mg and sumatriptan 50 mg (Imitrex) in the acute treatment of migraine. Poster presented at: International Headache Congress; Amsterdam; June 1997.

3 Tfelt-Hansen P, Teall J, Rodriguez F, et al. Oral rizatriptan versus oral sumatriptan: a direct comparative study in the acute treatment of migraine. Headache 1998; 38:748-755.

4 Goldstein J, Ryan R, Jiang K, et al. Crossover comparison of rizatriptan 5 mg and 10 mg versus sumatriptan 25 mg and 50 mg in migraine. Headache 1998; 38:737-747.

5 Kolodny A, Polis A, Battisti WP, et al. Comparison of rizatriptan 5 mg and 10 mg tablets and sumatriptan 25 mg and 50 mg tablets. Cephalalgia 2004; 24:540-546.

6 Web site, World Health Organization: www.migraines.org/new/pdfs/who.pdf

7 Volans GN. Migraine and drug absorption. Clin Pharmacokinetics 1978; 3:313-18

8 Walls C, Lewis A, Bullman J et al. Pharmacokinetic profile of a new form of sumatriptan tablets in healthy volunteers. Current Medical Research and Opinion 2004; 20:803-80

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