Forest to Discontinue Development in U.S. of Dexloxiglumide for Irritable Bowel Syndrome (IBS)
Public Company Information:
Forest Laboratories, Inc. (NYSE: FRX) announced today that it has discontinued development of dexloxiglumide for the treatment of constipation predominant irritable bowel syndrome (IBS) in the U.S. Forest licensed U.S rights for dexloxiglumide from Rotta Research Laboratorium of Italy. This decision was based on the outcome of two just completed placebo-controlled Phase III clinical studies involving over 1,400 women with constipation predominant IBS and of 12 weeks duration of treatment. Although a numeric trend was observed in favor of dexloxiglumide in both studies, the difference compared to placebo was not statistically significant.
The primary endpoint in the two studies was the Subject Global Assessment, which measures a patient's overall evaluation of abdominal discomfort, pain and altered bowel habit. Both clinical trials suggested that dexloxiglumide had limited side effects and no effect on gallstone formation.
Dexloxiglumide, a CCK-1 antagonist, represents a novel mode of action for the treatment of IBS which demonstrated promising results in a large Phase II study conducted by Rotta Research. Rotta Research, the originator of dexloxiglumide, is continuing a separate placebo-controlled Phase III trial in Europe of a different design in constipation predominant IBS, in compliance with the current guidelines of the European Medicine Evaluation Agency (EMEA), that has different requirements from the U.S. FDA.
Forest and Rotta Research will also continue to evaluate whether dexloxiglumide may have promise in other indications which may be studied in the future.
About Forest Laboratories and Its Products
Forest Laboratories' growing line of products includes: LexaproTM, indicated for the initial and maintenance treatment of major depressive disorder; CelexaTM, an antidepressant; Tiazac(R), a once-daily diltiazem, indicated for the treatment of angina and hypertension; Benicar(R)*, an angiotensin receptor blocker indicated for the treatment of hypertension; and Aerobid(R), an inhaled steroid indicated for the treatment of asthma.
Except for historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties that affect our business, including risk factors listed from time to time in the Company's SEC reports, including the Company's Annual Report on Form 10-K for the fiscal year ended March 31, 2003 and Quarterly Report on Form 10-Q for the period ended June 30, 2003. Actual results may differ materially from those projected.
* Benicar is a registered trademark of Sankyo Pharma.