Forest Laboratories, Inc. and Cypress Bioscience, Inc. Announce Positive Results of Phase III Study for Milnacipran as a Treatme
May 22 2007 - 5:56PM
PR Newswire (US)
NEW YORK, May 22 /PRNewswire-FirstCall/ -- Forest Laboratories,
Inc. (NYSE:FRX) and Cypress Bioscience, Inc. (NASDAQ:CYPB) today
announced that preliminary top-line results from a 1,196 patient
randomized, three month, double-blind, placebo-controlled pivotal
Phase III study demonstrate statistically significant therapeutic
effects of milnacipran as a treatment of fibromyalgia syndrome. At
this time the companies have only been able to review initial
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 )
Preliminary Study Results In the study, patients were randomized to
receive either 200mg per day of milnacipran (n=396), 100mg per day
of milnacipran (n=399) or placebo (n=401). The primary pre-defined
endpoints of this trial were composite responder assessments to
evaluate either the treatment of the pain associated with
fibromyalgia syndrome or the overall treatment of fibromyalgia
syndrome. This composite responder analysis approach, which
requires a clinically meaningful improvement in multiple domains,
captures in one endpoint improvement in numerous symptoms which
comprise this syndrome. The treatment of pain associated with
fibromyalgia is assessed by evaluating pain as measured by the
Patient Experience Diary (PED), and the overall impression of
patient well being as measured by the Patient Global Impression of
Change (PGIC) for patients receiving either dose of milnacipran
compared to placebo. The difference between active doses and
placebo was assessed by a responder analysis with a responder
defined as a subject experiencing both a 30% or greater reduction
in pain compared to baseline as measured by a visual analog scale
(VAS) and a self assessment of his or her condition by the patient
of either "much" or "very much" improved compared to baseline. The
broader evaluation of treatment of fibromyalgia syndrome is
assessed by evaluating pain as measured by the Patient Experience
Diary (PED), the overall impression of patient well being as
measured by the Patient Global Impression of Change (PGIC) and an
analysis of physical function as measured by the SF-36 Physical
Component Summary for patients receiving either dose of milnacipran
compared to placebo. The difference between active doses and
placebo was assessed by a responder analysis with a responder
defined as a subject meeting the criteria for the treatment of pain
associated with fibromyalgia and in addition showing improvement in
physical function as assessed by the SF-36 Physical Component
Summary. Treatment of Pain Associated with Fibromyalgia This
endpoint showed statistically significant improvement for
milnacipran compared to placebo for patients receiving 200 mg per
day of milnacipran (p=0.004) and for patients receiving 100 mg per
day of milnacipran (p=0.025). These results were analyzed using the
Baseline Observation Carried Forward (BOCF) analysis, as agreed to
with the U.S. Food and Drug Administration (FDA). Treatment of
Fibromyalgia Syndrome This endpoint also showed statistically
significant improvement for milnacipran compared to placebo for
both the 200mg per day dose (p=0.015) and 100mg per day dose
(p=0.011) using the Baseline Observation Carried Forward (BOCF)
analysis. Results for both endpoints listed above were also
statistically significant when analyzed using a Last Observation
Carried Forward (LOCF) method. Component Assessments In addition,
when analyzed according to the pre-specified analysis plan both the
pain and the PGIC components of the composite endpoint individually
achieved statistical significance in favor of milnacipran at both
doses and the SF-36 Physical Component Summary met statistical
significance at one dose. Tolerability Milnacipran was generally
well tolerated, with the majority of patient withdrawals occurring
early in the trial. Overall premature discontinuation rates (all
causes including adverse event related) were 35% for patients
receiving 200mg per day of milnacipran, 34% for patients receiving
100mg per day of milnacipran and 28% for patients receiving
placebo. The most common adverse events that led to early
withdrawal among the milnacipran treated patients were nausea,
palpitations, depression and headache, each of which occurred at a
rate of less than 5%. Future Development Plans Subject to a
favorable review of the full study results for the just completed
trial and based in part on communication with the FDA, the
Companies would plan to submit a New Drug Application (NDA)
including data from this study and the first Phase III study for
milnacipran around the end of 2007. About Milnacipran Milnacipran
is the first of a new class of agents known as norepinephrine
serotonin reuptake inhibitors, or NSRIs, which exerts its effect by
preferentially inhibiting the reuptake of norepinephrine over
serotonin, two neurotransmitters known to play an essential role in
regulating pain and mood. It has been approved for the treatment of
depression in over 32 countries and has been used safely by more
than 5 million patients during more than seven years of commercial
availability outside the U.S. Milnacipran is being developed for
fibromyalgia in the United States market jointly by Forest and its
licensor, Cypress Biosciences, Inc. About Fibromyalgia (FMS) FMS is
a chronic and debilitating condition characterized by widespread
pain and stiffness throughout the body, accompanied by severe
fatigue, insomnia and mood symptoms. According to the American
College of Rheumatology, FMS is estimated to affect over six
million people in the United States. FMS is most often diagnosed in
the primary care setting and in addition is the second most
commonly diagnosed condition in rheumatology clinics in the United
States after osteoarthritis. Despite the high prevalence and
severity of this syndrome, there are no treatments specifically
approved for FMS in the United States or elsewhere and the
addressable patient population is not yet well established. For
more information about fibromyalgia, visit
http://www.fmsresource.com/. About Cypress Cypress is committed to
be the innovator and leader in providing products that improve the
treatment of Functional Somatic Syndromes and other central nervous
system conditions, including fibromyalgia syndrome. Cypress'
strategy involves acquiring/in-licensing undervalued central
nervous system active compounds and developing them for new
indications. For more information about Cypress, please visit
Cypress' web site at http://www.cypressbio.com/. This press
release, as well as Cypress' SEC filings and web site 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 Syndrome and our planned NDA filing for
milnacipran. 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; the FDA may not accept our first Phase III clinical
trial as one of the two pivotal trials required for NDA approval,
that upon further reflection that we may determine not to submit an
NDA in 2007, that we may not be able to protect our milnacipran
patent portfolio and that milnacipran may never be approved as a
drug by the FDA. 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. 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, 2006 and on Form 10-Q for the
periods ended June 30, 2006, September 30, 2006 and December 31,
2006. http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
http://photoarchive.ap.org/ DATASOURCE: Forest Laboratories, Inc.
and Cypress Bioscience, Inc. CONTACT: Sabrina Martucci-Johnson,
Chief Financial Officer or Mary Geison, Investor Relations, both of
Cypress Bioscience, Inc., +1-858-452-2323; or Charles E. Triano,
Vice President - Investor Relations, Forest Laboratories, Inc.,
+1-212-224-6714, or Web site: http://www.frx.com/
http://www.fmsresource.com/ http://www.cypressbio.com/
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