Re: NEW GERD treatment

[Guest guest]

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Hi- I got this from another list and thought some of you might be

interested.

Sharon

FDA Approves Aciphex For Reflux Disease And Duodenal Ulcers

NEW YORK -- Aug. 20 -- PRNewswire -- Eisai Inc. has received marketing

clearance from the U.S. Food and Drug Administration for Aciphex™

(rabeprazole sodium), a new proton pump inhibitor (PPI).

Aciphex will be marketed in the United States by Eisai Inc., an affiliate

of Eisai Co., Ltd. of Tokyo, Japan, and Janssen Pharmaceutica, a subsidiary

of & .

The FDA approved Aciphex for healing of erosive gastroesophageal reflux

disease (GERD), maintenance of healed erosive GERD and healing of duodenal

ulcers. Aciphex also has been approved for the treatment of pathological

hypersecretory conditions, including Zollinger-Ellison syndrome.

" Our research shows that Aciphex demonstrates features, such as consistent

acid control from the first dose, that should prove attractive to

physicians who treat GI disorders, " said Malcolm , MD, clinical

professor of medicine at the University of Oklahoma College of Medicine,

and the founder and medical director of the Oklahoma Foundation for

Digestive Research. " This new product will offer patients a highly

effective treatment choice. "

More than 60 million Americans suffer from GERD and heartburn, a common

GERD symptom, at least once a month, and 25 million sufferers report

symptoms on a daily basis.(1) Many of these patients have severe symptoms

and are often diagnosed with erosions in the lining of the esophagus, a

condition called erosive GERD.

Aciphex will be available in 20 mg, enteric-coated tablets to be prescribed

once daily.

In clinical trials, Aciphex demonstrated a favorable side-effect profile.

Headache was the most common side effect assessed as possibly related to

Aciphex (2.4 percent vs. 1.6 percent for placebo). Aciphex is

contraindicated in patients with known sensitivity to rabeprazole,

substituted benzimidazoles or any component of the formulation. As is the

case for other proton pump inhibitors, symptomatic response to therapy with

Aciphex does not preclude the presence of gastric malignancy. Proton pump

inhibitors, however, are an established class of drugs that has been shown

to be safe and well tolerated.

In April 1997, Eisai Co., Ltd. and Janssen Pharmaceutica of Beerse,

Belgium, formed a strategic alliance to bring the drug to market.

The Japanese Ministry of Health and Welfare cleared rabeprazole sodium for

marketing in 1997, and the drug is successfully marketed there under the

trade name Pariet®. Pariet® was approved in the United Kingdom in May 1998,

and for marketing in all 14 other European Union countries beginning in

September 1998.

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