Lantus
22/09/2004, 07h14
Le comprimé Imigran(TM) de 100mg est le premier triptan à commencer
à soulager au bout de 20 minutes
Les résultats d'un nouvel essai présentés ce jour lors du 15ème
colloque international organisé par Migraine Trust démontrent que la
nouvelle formulation de comprimé de 100mg à dissolution rapide de
l'Imigran(TM) (sumatriptan succinate) commence à soulager les
patients 20 minutes après la prise.
The summary translation is provided for editorial guidance
purposes. The original message of the issuer is the official and
authoritative version of the release.
( BW)(GLAXOSMITHKLINE) GlaxoSmithKline: New Formulation of Imigran -
Sumatriptan Succinate - Demonstrated to Start Working in as Fast as 20
Minutes
Business Editors/Health/Medical Writers
LONDON--(BUSINESS WIRE)--Sept. 21, 2004--
Imigran(TM) 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(TM) (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.
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 Zurich, 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, according to the World
Health Organisation.
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.(1) 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.(2) 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.
à soulager au bout de 20 minutes
Les résultats d'un nouvel essai présentés ce jour lors du 15ème
colloque international organisé par Migraine Trust démontrent que la
nouvelle formulation de comprimé de 100mg à dissolution rapide de
l'Imigran(TM) (sumatriptan succinate) commence à soulager les
patients 20 minutes après la prise.
The summary translation is provided for editorial guidance
purposes. The original message of the issuer is the official and
authoritative version of the release.
( BW)(GLAXOSMITHKLINE) GlaxoSmithKline: New Formulation of Imigran -
Sumatriptan Succinate - Demonstrated to Start Working in as Fast as 20
Minutes
Business Editors/Health/Medical Writers
LONDON--(BUSINESS WIRE)--Sept. 21, 2004--
Imigran(TM) 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(TM) (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.
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 Zurich, 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, according to the World
Health Organisation.
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.(1) 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.(2) 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.