Forest Laboratories, Inc. and Gedeon Richter Announce Results of Phase II-B Study for RGH-188 as a Treatment for Sch...(was a flexible fixed dosage range study ...),Health

Date:10/15/2007

was a flexible fixed dosage range study in which patients received 1 to 3 capsules administered as a single daily dose at bedtime. All patients started with 1 capsule (placebo or RGH-188 1.5 mg). The daily dose could be increased to 3 capsules given once daily by Day 5 or thereafter depending on patient response and tolerability based on investigator's judgment. For patients randomized to RGH-188 low dose (1.5-4.5 mg/day) group, the maximum dose of 4.5 mg per day could be reached by Day 5, whereas for patients randomized to RGH-188 high dose (6-12 mg/day) group, the maximum dose of 12 mg per day could be reached by Day 9. Following a dose increase, the dose could be decreased if there were any tolerability problems. Any increases or decreases were to be done in increments or decrements of one capsule.

RGH-188 was generally well tolerated and overall premature discontinuation rates (all causes including adverse event related) were 47% for patients receiving low dose of RGH-188, 46% for patients receiving high dose RGH-188, and 47% for patients receiving placebo.

Future Development Plans

Based on the initial positive results for one of the active dosing arms and subject to a complete review of the full study results for the just completed trial, the Companies intend to continue the development of RGH-188 as a treatment for schizophrenia and will determine the appropriate development activities over the coming months.

Additionally, the Companies expect to receive topline results for the proof of concept study for RGH-188 in bipolar mania in by the middle of calendar 2008.

About RGH-188

RGH-188 (INN: cariprazine) discovered by researchers at Gedeon Richter, is a novel antipsychotic which preferentially binds to D3 receptors and acts as a dopamine system stabilizer.

About Forest Laboratories and Its Products

Forest Laboratories (http://www.frx.com) is a US-based pharmaceutical
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SOURCE Forest Laboratories, Inc. Copyright©2007 PR Newswire. All rights reserved

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