Home » Drug Information » FDA Approved Drugs » 2002
Medical Areas: Gastroenterology | Hepatology (Liver, Pancreatic, Gall Bladder)
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Protonix (pantoprazole sodium) Delayed Release Tablets
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved April 2002
Treatment Area: Gastroesophageal disorders
Protonix is an acid suppressant originally approved in February
2000 for the short-term treatment, of up to eight weeks, and
symptomatic relief of erosive esophagitis (EE) associated with
gastroesophageal reflux disease (GERD). In June 2001 Protonix
Delayed Release Tablets were additionally approved for the
maintenance of healing of EE and daytime and nighttime control of
heartburn associated with GERD. The indication was further expanded
in April 2002 with Protonix's approval for the long-term
treatment of pathological hypersecretory conditions, including
Esophagitis may be caused by irritation of the esophagus due to
acid reflux from the stomach to the esophagus. Although 36% of
healthy Americans experience this sort of reflux at least once a
month, up to 10% of suffer from GERD on a daily basis. EE can be a
precursor to more serious esophageal diseases.
Zollinger-Ellison Syndrome is a rare and potentially deadly
disease that typically affects those between the ages of 30 and 50.
It is caused by a neuroendocrine tumor, called a gastrinoma,
located in the pancreas or duodenum. Due to the tumor, high levels
of gastrin are circulated, which results in excessive levels of
gastric acid secretion and leads to severe ulceration of the upper
gastrointestinal tract. Such lack of control over acid levels may
lead to serious complications.
The approval Protonix for the treatment of EE associated with
GERD is supported by two double-blind, placebo-controlled dose
escalating studies with approximately 850 subjects with reflux
symptoms and endoscopically diagnosed EE. All three dosages used
yielded significantly better healing rates than placebo, with the
40 mg dose proving most effective. Subjects in that group
experienced complete cessation of heartburn and consumed
significantly fewer antacid tablets per day starting on the first
day of treatment.
Two randomized, double-blind, comparator-controlled trials were
conducted in 790 GERD subjects with endoscopically-confirmed healed
EE, to determine the effectiveness of Protonix in long-term
maintenance of healing. Protonix 40 mg was significantly superior
to the comparator at every time point for the maintenance of
healing and for reduction in daytime and nighttime heartburn
Protonix's approval for the treatment of Zollinger-Ellison
Syndrome is based on a multi-center trial with 35 subjects with
Zollinger-Ellison Syndrome or another hypersecretory condition.
Results showed that acid output was controlled for most subjects
for up to six months and that at six months, 94% of subjects had
responded to treatment.
Adverse events associated with the use of Protonix
(pantoprazole) may include (but are not limited to) the
- Abdominal pain
Mechanism of Action
Pantoprazole is a proton pump inhibitor (PPI) that suppresses
the final step in gastric acid production by forming a covalent
bond to two sites of the (H+, K+)-ATPase enzyme system at the
secretory surface of the gastric parietal cell. This effect is
dose-related and leads to inhibition of both basal and stimulated
gastric acid secretion irrespective of the stimulus. The binding to
the (H+, K+)-ATPase results in a duration of antisecretory effect
that persists longer than 24 hours. (From FDA Label)
For additional information on Protonix Delayed Release Tablets,
please visit Protonix.