Forest Laboratories, Inc. and Gedeon Richter Announce Results of Phase II-B Study for RGH-188 as a Treatment for Sch...( NEW YORK and BUDAPEST Hungary Oct...),Health

NEW YORK and BUDAPEST, Hungary, Oct. 15 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX) and Gedeon Richter today announced preliminary top-line results from a U.S. conducted randomized, double-blind, three-arm placebo-controlled study of RGH-188, a novel antipsychotic, in 389 schizophrenia patients. The protocol-specified primary endpoint was change from baseline to Week 6 on the Positive and Negative Syndrome Scale (PANSS) and RGH-188 demonstrated a nominally statistically significant (i.e., not adjusted for multiple comparisons) therapeutic effect compared to placebo in the treatment of schizophrenia in the low dose arm and a numerical improvement compared to placebo in the high dose arm that did not reach nominal statistical significance. At this time the companies have only been able to review top-line results and further analyses will be completed in the coming weeks to examine the results in greater detail.

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Trial Design and Preliminary Study Results

Following a no-drug washout period of up to 7 days, patients (N=389) were randomized to one of three treatment groups: placebo, RGH-188 low dose (1.5- 4.5 mg/day) or RGH-188 high dose (6-12 mg/day). The double-blind treatment period lasted 6 weeks. Patients were hospitalized throughout screening and for at least the first 21 days following the initiation of double-blind study medication. Following completion of the 6 weeks of double-blind treatment, patients were followed up for safety assessments for an additional 4 weeks. The study was conducted entirely in the United States.

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