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FDA Approves Prevacid (Lansoprazole) for Use in Adolescents with Gastroesophageal Reflux Disease, Erosive Esophagitis

LAKE FOREST, IL -- June 30, 2004 -- TAP Pharmaceutical Products Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Prevacid® (lansoprazole) for the short-term treatment of symptomatic gastroesophageal reflux disease (GERD) and erosive esophagitis in children aged 12 to 17 years, expanding its approved use in children to 1 to 17 years. Currently, Prevacid is the only proton pump inhibitor (PPI) approved for use by children as young as one year old.

"Although people often think of heartburn related to acid reflux disease as an adult condition, many children and teens are affected by it," said Xavier Frapaise, M.D., vice president of research and development at TAP. "It is important that there are FDA-approved treatment options for teens who experience the often painful symptoms of acid reflux disease, such as heartburn."

In an open-label, U.S. multicenter study, 87 adolescent patients (12 to 17 years of age) with symptomatic GERD were assigned to receive either Prevacid 15 mg or 30 mg once daily. At the beginning of the study, most patients (89 percent) had mild to moderate overall GERD symptoms. Sixty-four patients had nonerosive GERD and were treated with Prevacid 15 mg daily for eight weeks, while 23 patients had erosive esophagitis and were treated with Prevacid 30 mg daily for eight to twelve weeks. Erosive esophagitis is a condition in which the lining of the esophagus has been damaged.

At the end of the study period, Prevacid was found to be safe and effective in treating patients with symptomatic GERD, including erosive esophagitis. Of 22 patients with erosive esophagitis evaluated, 95.5 percent (21 patients) were healed after eight weeks of Prevacid treatment, which is similar to healing rates found in adults (92 percent to 95 percent).

"This approval is an important milestone for Prevacid in the treatment of acid reflux disease," said H. Thomas Watkins, president of TAP. "Prevacid is now available to help a larger group of patients, further reinforcing its leadership position in the PPI market."

Prevacid offers a variety of administration options that can be used by children and teens. Prevacid for oral suspension is the only PPI available in this type of formulation, as well as the only PPI to offer an orally disintegrating tablet, Prevacid SoluTab(TM). Prevacid SoluTab is a formulation that disintegrates quickly in the mouth, usually in less than 60 seconds, and can be taken with or without water. Prevacid SoluTab should not be chewed. Patients should simply place the tablet on the tongue and allow it to disintegrate until the particles can be swallowed.

Symptomatic response to therapy does not preclude the presence of gastric malignancy. Prevacid is contraindicated in patients with known hypersensitivity to any component of the formulation. The most frequently reported adverse events in patients aged 12 to 17 years include headache (7 percent), abdominal pain (5 percent), nausea (3 percent) and dizziness (3 percent). In patients between the ages of 1 to 11 years, the most frequently reported adverse events were constipation (5 percent) and headache (3 percent). There were no adverse events reported in U.S. clinical studies that were not previously observed in adults.

Use of Prevacid in patients aged 1 to 17 years is supported by evidence from adequate and well-controlled studies of Prevacid in adults with additional clinical, pharmacokinetic, pharmacodynamic and safety studies performed in pediatric patients. Safety and effectiveness have not been established in patients less than one year old.

For further information about Prevacid, please see the complete prescribing information and visit http://www.Prevacid.com.



About Prevacid® (lansoprazole)

Oral Prevacid formulations have the most approved indications and the most administration options of any PPI.

Prevacid is indicated for the short-term (up to eight weeks) treatment of heartburn and other symptoms of gastroesophageal reflux disease (GERD), as well as for the following:

-- Healing and risk reduction of recurrence of gastric (stomach) ulcers associated with NSAIDs (non-steroidal anti-inflammatory drugs) in chronic NSAID users -- the only PPI approved for this use. Controlled studies for healing were conducted up to eight weeks and controlled studies for risk reduction of recurrence were conducted up to 12 weeks.

-- Short-term (up to eight weeks) healing and symptom relief of all grades (severe to mild) of erosive esophagitis, a condition in which the lining of the esophagus has been damaged.

-- Maintenance of healed erosive esophagitis. Controlled studies were conducted up to 12 months.

-- Short-term (up to eight weeks) treatment of active benign gastric ulcers.

-- Short-term (four weeks) treatment of duodenal ulcers, which are ulcers found on the first part of the small intestine.

-- Maintenance of healed duodenal ulcer. Controlled studies were conducted up to 12 months.

-- Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome, which involves the overproduction of stomach acid.



In adults, the most frequently reported adverse events were diarrhea (3.8 percent), abdominal pain (2.1 percent) and nausea (1.3 percent).


SOURCE: Abbott Laboratories

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