Home » Drug Information » FDA Approved Drugs » 2001
Medical Areas: Gastroenterology | Family Medicine
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Nexium (esomeprazole magnesium)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved February 2001
Treatment Area: Duodenal ulcer disease, erosive esophagitis, and gastroesophageal reflux disease
Nexium has been approved by the FDA for the relief of heartburn
and other symptoms associated with gastroesophageal reflux disease
(GERD) and for the healing of erosive esophagitis, a potentially
serious condition associated with GERD. The FDA also approved
Nexium for maintenance of healing of erosive esophagitis and, in
combination with amoxicillin and clarithromycin, for the
eradication of Helicobacter pylori infection in patients
with duodenal ulcer disease.
Nexium is derived from Prilosec (omeprazole). Prilosec contains
a racemic mixture of the D- and L- forms (isomers) of omeprazole.
Nexium contains only one of the isomers. Both Prilosec and Nexium
are known as proton pump inhibitors.
As many as 25 million adults experience heartburn on a daily
basis. Although heartburn is the most common symptom of GERD, the
condition is also often marked by other symptoms - such as a sour
taste in the mouth or difficulty swallowing - related to the
backing up of harsh stomach acid into the esophagus. When this acid
reflux damages the lining of the esophagus, it may lead to a
potentially more serious condition called erosive esophagitis that
can lead to narrowing or ulceration of the esophagus.
Four multicenter, double-blind, randomized trials evaluated the
healing rates of Nexium 40 mg, Nexium 20 mg, and omeprazole 20 mg
in subjects with endoscopically diagnosed erosive esophagitis.
Healing rates were evaluated at week four and eight. At week eight,
healing rates were higher with Nexium treatment compared to
omeprazole in all four studies.
Two multicenter, randomized, double-blind, placebo-controlled
4-arm trials evaluated the long-term maintenance of healing of
erosive esophagitis. The trials included subjects with
endoscopically confirmed, healed erosive esophagitis, and they
evaluated Nexium 40 mg, 20 mg and 10 mg once-daily over six months
of treatment. Subjects remained in remission significantly longer
and the number of recurrences of erosive esophagitis was
significantly less in subjects treated with Nexium compared to
Nexium's effectiveness in the resolution of GERD symptoms
was evaluated in two multicenter, randomized, double-blind,
placebo-controlled trials. These trials were conducted in a total
of 717 subjects, and they compared four weeks of treatment with
Nexium 20 mg or 40 mg once daily versus placebo. The percentage of
subjects who were symptom-free of heartburn was significantly
higher in the Nexium groups compared to placebo at all follow-up
visits (weeks 1, 2 and 4).
In three European symptomatic GERD trials, no significant
treatment related differences were observed between Nexium 20 mg
and 40 mg and omeprazole 20 mg.
Nexium in combination with amoxicillan and clarithromycin was
tested in two multicenter, randomized, double-blind trials for the
eradication of Helicobacter pylori (H. pylori) in subjects with
duodenal ulcer disease. H. pylori eradication rates at four weeks
post-therapy were significantly higher in the Nexium plus
amoxicillin and clarithromycin group than in a Nexium plus
clarithromycin or Nexium alone group.
Side effects reported with Nexium use include (but are not
limited to) the following:
- Abdominal pain
Safety and effectiveness have not yet been established in
Please consult your physician for further information on side
effects or to discuss the individual appropriateness of Nexium
Mechanism of Action
Esomeprazole is a proton pump inhibitor that suppresses gastric
acid secretion by specific inhibition of H+/K+-ATPase in the
gastric parietal cell. By acting specifically on the proton pump,
esomeprazole blocks the final step in acid production, thus
reducing gastric acidity. This effect is dose-related up to a daily
dose of 20 to 40 mg and leads to inhibition of gastric acid
secretion. (Nexium Prescribing Information)
Nexium is produced in a delayed-release capsule formulation,
with dosages of 20 mg or 40 mg.
For additional information on Nexium, please visit