||FDA Approves AstraZeneca's Nexium With Comprehensive Set Of Indications
Be Available On Prescription In The US Next Month
AstraZeneca has announced that the FDA has approved Nexium an anti-ulcer medication, with a full set of indications. The US label compares favourably with
both the US Prilosec label and with those received so far in Europe for Nexium which
has had a launch that is among the best in the pharmaceutical industry's history.
be available on prescription in the US in March.
The FDA has approved Nexium with a comprehensive set of indications as follows:
- · Heartburn and other symptoms associated with gastro-esophageal reflux disease
- · The healing and symptom resolution of erosive esophagitis, a potentially serious
condition associated with GERD.
- · The maintenance of both healing and symptom resolution of esophagitis.
- · The eradication of Helicobacter pylori infection in patients with duodenal ulcer disease
in 10 days, in combination with certain antibiotics.
The label confirms that Nexium 40mg demonstrates higher healing rates in erosive
esophagitis than Prilosec 20mg (the approved dose for this indication). In three studies,
Nexium 40mg consistently demonstrated higher healing rates than Prilosec 20mg and
two of these studies were statistically significant. Healing rates achieved for Nexium
20mg were between those achieved with Nexium 40mg and Prilosec 20mg.
Sustained resolution of heartburn was achieved in 5 days for Nexium 40mg; 7-8 days
for Nexium 20mg against 7-9 days for Prilosec 20mg. After four weeks of 40mg
Nexium treatment, a higher percentage of patients achieved sustained resolution of
heartburn than with Prilosec 20mg.
In clinical trials, the safety profile of Nexium was similar to that of Prilosec. The most
frequently occurring side effects were headache, diarrhoea and abdominal pain.
The catalogue price to wholesalers has been set at $3.33 for either a Nexium 20mg or
Nexium 40mg capsule. The catalogue price to wholesalers of Prilosec 20mg is $3.45.
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Editor: Susan K. Boyer, RN
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