Forest Laboratories, Inc. and Cypress Bioscience, Inc. Announce Positive Results of Phase III Study of Milnacipran for the Manag
December 08 2008 - 8:00AM
PR Newswire (US)
NEW YORK and SAN DIEGO, Dec. 8, 2008 /PRNewswire-FirstCall/ --
Forest Laboratories, Inc. (NYSE:FRX) and Cypress Bioscience, Inc.
(NASDAQ:CYPB) today announced positive top-line results from a
1,025 patient, multicenter, double-blind, placebo-controlled phase
III study of milnacipran for the management of fibromyalgia. These
results, which confirm the findings from the two previous phase III
trials, showed that milnacipran demonstrated a highly statistically
significant difference to placebo in responder analyses based on a
concurrent and clinically meaningful improvement in pain, patient
global impression of change, and physical functioning.
Comprehensive analyses of the study data will be completed in the
coming weeks, and it is anticipated that further results will be
presented during 2009. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) Study
Background In this study, designated MLN-MD-03, patients with an
established history of fibromyalgia were enrolled at 75 centers in
North America and randomized to receive a daily dose of 100 mg of
milnacipran (n=516) or placebo (n=509). The design of the
double-blind study included a 4 to 6-week dose escalation phase, a
12-week stable-dose treatment phase, and a 2-week discontinuation
phase. The primary efficacy endpoints were the proportion of
subjects meeting criteria as composite responders based on one of
two definitions. In the first co-primary analysis, a patient had to
demonstrate simultaneous improvements on both their daily pain
ratings (visual analog scale) and on an overall measure of how
their fibromyalgia condition had been since the start of the study
(Patient Global Impression of Change or PGIC). In the second
co-primary analysis, a patient had to demonstrate simultaneous
improvements on three measures -- pain, PGIC, and physical
functioning (as measured by the SF-36 Physical Component Summary).
Preliminary Results A greater proportion of patients treated with
milnacipran (100 mg/day) experienced at least a 30% reduction in
pain from baseline and also rated themselves as "very much
improved" or "much improved" based on the patient global assessment
(PGIC) (p < 0.001). In addition, a greater proportion of
patients treated with milnacipran met the criteria for a treatment
response as measured by concurrent improvements in pain, patient
global assessment (PGIC) and physical function (improvement of at
least 6 points in SF-36 PCS), as compared to subjects on placebo (p
< 0.001). Primary analysis results were conducted using the
Baseline Observation Carried Forward (BOCF) imputation method.
Milnacipran was generally well tolerated. Similar to the safety
data from the two previous U.S. phase III trials of milnacipran in
fibromyalgia, the most common treatment emergent adverse events
observed through the stable-dose treatment period of the
placebo-controlled trial included nausea (37% vs. 21% placebo),
constipation (15% vs. 4% placebo), hot flush (11% vs. 4% placebo),
dizziness (11% vs. 5% placebo), hyperhidrosis (8% vs. 1% placebo),
palpitations (7% vs. 3% placebo), tachycardia (5% vs. 1% placebo),
and hypertension (5% vs. 1%). Overall premature discontinuation
rates (all causes including adverse event related) through the
stable-dose treatment period of the trial were 31% for patients
receiving 100 mg per day of milnacipran, and 30% for patients
receiving placebo. Similar to the safety data from the two previous
U.S. phase III trials of milnacipran in fibromyalgia, the most
common adverse events that led to early withdrawal among the
milnacipran treated patients were nausea (3.5%) and headache and
palpitations, each of which occurred at a rate of less than 2%.
About Milnacipran Milnacipran is a dual-reuptake inhibitor that
preferentially blocks the reuptake of norepinephrine with higher
potency than serotonin, two neurotransmitters thought to play a
central role in the symptoms of fibromyalgia. Milnacipran is being
developed for fibromyalgia in the United States jointly by Forest
Laboratories, Inc. and its licensor, Cypress Bioscience, Inc.
Milnacipran was originally developed, and is sold outside of the
U.S. by Pierre Fabre Medicament. The FDA accepted for review the
New Drug Application (NDA) for milnacipran for the management of
fibromyalgia in February 2008. The application includes efficacy
data from two pivotal phase III trials involving 2,084 patients
(1,460 milnacipran, 624 placebo-treated subjects), which showed
that milnacipran demonstrated improvement compared to placebo in
treating the symptoms of fibromyalgia based on responder analyses.
As previously disclosed, the FDA has yet to provide an action based
on the NDA application. The Prescription Drug User Fee Act (PDUFA)
date was October 18, 2008. About Fibromyalgia Fibromyalgia is a
chronic and debilitating condition characterized by widespread pain
and decreased physical functioning. According to the American
College of Rheumatology fibromyalgia is estimated to affect over 6
million Americans. It is most often diagnosed in the primary care
setting and is the second most commonly diagnosed condition in
rheumatology clinics in the United States after osteoarthritis.
Despite the high prevalence and severity of this condition, there
are limited treatment options specifically approved for
fibromyalgia in the United States. About Forest Laboratories Forest
Laboratories (NYSE:FRX) is a U.S.-based pharmaceutical company with
a long track record of building partnerships and developing and
marketing products that make a positive difference in people's
lives. In addition to its well-established franchises in
therapeutic areas of the central nervous and cardiovascular
systems, Forest's current pipeline includes product candidates in
all stages of development and across a wide range of therapeutic
areas. The company is headquartered in New York, NY. To learn more
about Forest Laboratories, visit http://www.frx.com/. 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 Forest Laboratories'
Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and any
subsequent SEC filings. About Cypress Bioscience Cypress
Bioscience, Inc. is developing therapeutics and personalized
medicine services, to facilitate improved and individualized
patient care. Cypress' goal is to address the evolving needs of
specialist physicians and their patients by identifying unmet
medical needs in the areas of pain, rheumatology, and physical
medicine and rehabilitation, including challenging disorders such
as fibromyalgia and rheumatoid arthritis. We intend to use this
approach to improve patient care and create a unique partnership
with physicians. For more information about Cypress, please visit
the Company's website at http://www.cypressbio.com/. This press
release, as well as Cypress' SEC filings and website at
http://www.cypressbio.com/, contain forward-looking statements
within the meaning of the Private Securities Litigation Reform Act
of 1995, including statements about the potential of milnacipran to
treat fibromyalgia. Actual results could vary materially from those
described as a result of a number of factors, including those set
forth in Cypress' Annual Report on Form 10-K, the most recent
Quarterly Report on Form 10-Q and any subsequent SEC filings and
including, but not limited to, that more detailed analysis of the
trial results may not be favorable or may lead to different
conclusions and that milnacipran may not be approved by the FDA for
the management of fibromyalgia and even if approved may not achieve
market acceptance.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGODATASOURCE:
Forest Laboratories, Inc.; Cypress Bioscience, Inc. CONTACT: Forest
Laboratories, Inc., Frank J. Murdolo, Vice President - Investor
Relations, +1-212-224-6714, ; Cypress Bioscience, Inc., Ciara
Kennedy, Sr. Director - Corporate Development or Mary Gieson,
Investor Relations, +1-858-452-2323, Web Site:
http://www.cypressbio.com/ http://www.frx.com/
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