Forest Laboratories, Inc. and Gedeon Richter Announce Results of Phase II-B Study for RGH-188 as a Treatment for Schizophrenia
October 15 2007 - 4:10PM
PR Newswire (US)
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. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) 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. This 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 company dedicated to identifying, developing and
delivering products that make a positive difference in peoples'
lives. Forest Laboratories' growing product line includes
Lexapro(R) (escitalopram oxalate), an SSRI indicated for adults for
the initial and maintenance treatment of major depressive disorder
and generalized anxiety disorder; Namenda(R) (memantine HCl), an
N-methyl D-aspartate (NMDA)-receptor antagonist indicated for the
treatment of moderate to severe Alzheimer's disease; Benicar(R)*
(olmesartan medoxomil), an angiotensin receptor blocker, and
Benicar* HCT(R) (olmesartan medoxomil-hydrochlorothiazide), an
angiotensin receptor blocker and diuretic combination product, each
indicated for the treatment of hypertension; and Campral(R)*
(acamprosate calcium), indicated in combination with psychosocial
support for the maintenance of abstinence from alcohol in patients
with alcohol dependence who are abstinent at treatment initiation.
*Benicar is a registered trademark of Daiichi Sankyo, Inc., and
Campral is a registered trademark of Merck Sante s.a.s., subsidiary
of Merck KGaA, Darmstadt, Germany. About Gedeon Richter Plc. Gedeon
Richter, (http://www.richter.hu/) headquartered in
Budapest/Hungary, is a major pharmaceutical company in Hungary and
one of the largest in Central Eastern Europe, with consolidated
sales of approximately 1 billion USD in 2006, and 4 billion USD
market capitalisation. The company was founded in 1901. Gedeon
Richter plays the role of a regional multinational company in
Central Eastern Europe and in the CIS, and has a growing presence
through its commercial subsidiaries in key EU countries, and the
USA. The company has a worldwide presence through its
representative offices, subsidiaries in 30 countries. It has
manufacturing sites in Hungary, Russia, Romania, Poland, India and
a recently acquired German R&D biotechnology production
facility. The product portfolio of the company covers almost all
important therapeutic areas. With its widely acknowledged steroid
chemistry expertise the company is a significant player in the
gynaecological field worldwide. 16 % of the company's revenue
results from original drug research and development activity. The
company has the largest R&D unit in Central Eastern Europe
focusing exclusively on CNS disorders. Following reorganization of
the proprietary R&D in 2000, main clinical targets are
schizophrenia, anxiety and chronic pain. Complementing its own
preclinical excellence R&D collaboration agreements were signed
with Mitsubishi Pharma Corporation (Japan) and Forest Laboratories
in 2004 and 2005. The company has an original R&D portfolio
with 16 ongoing projects including four compounds which are in
either in Phase I or Phase II clinical trials. Except for the
historical information contained herein, this release contains
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve
a number of risks and uncertainties, including the difficulty of
predicting FDA approvals, the acceptance and demand for new
pharmaceutical products, the impact of competitive products and
pricing, the timely development and launch of new products, and the
risk factors listed from time to time in the Forest Laboratories'
SEC reports, including the Company's Annual Report on Form 10-K for
the fiscal year ended March 31, 2007.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
http://photoarchive.ap.org/ DATASOURCE: Forest Laboratories, Inc.
CONTACT: Charles E. Triano, Vice President - Investor Relations, of
Forest Laboratories, Inc., +1-212-224-6714, Web site:
http://www.frx.com/ http://www.richter.hu/
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