Forest and Cypress Announce FDA Approval of Savella(TM) for the Management of Fibromyalgia
January 14 2009 - 7:24PM
PR Newswire (US)
New treatment option for the estimated 6 million Americans living
with this chronic, debilitating condition NEW YORK and SAN DIEGO,
Jan. 14, 2009 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE:FRX) and Cypress Bioscience, Inc. (NASDAQ:CYPB) today
announced that Savella(TM) (milnacipran HCl), a selective serotonin
and norepinephrine dual reuptake inhibitor, was approved by the
U.S. Food and Drug Administration (FDA) for the management of
fibromyalgia. Fibromyalgia is a chronic condition characterized by
widespread pain and decreased physical function, afflicting as many
as six million people in the United States. The safety and efficacy
of Savella was established in two US pivotal phase III clinical
trials involving over 2,000 patients with fibromyalgia. The studies
showed that Savella doses of 100 mg/day and 200 mg/day demonstrated
statistically significant and clinically meaningful concurrent
improvements in pain, patient global assessment, and physical
function. The companies expect Savella to be available in
pharmacies by March 2009. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
"Fibromyalgia is a complicated chronic pain condition, so it is
important that physicians and patients have access to treatments
that have been shown to help manage the symptoms that define the
experience of fibromyalgia," said Dr. Daniel Clauw, Professor of
Anesthesiology and Medicine (Rheumatology) at the University of
Michigan. "The introduction of Savella is important because it is
the first drug approved to treat the symptoms of fibromyalgia using
a composite responder analysis.". "Savella is the product of a
unique clinical development program, one that considered a patient
to be a responder to therapy only if they demonstrated concurrent
clinically significant changes in multiple aspects of their
fibromyalgia, including pain, patient global assessment and
physical function. Savella is the only product approved for the
management of fibromyalgia that used this complete responder
analysis as its primary endpoint," said Jay D. Kranzler, MD, PhD,
Chairman and CEO of Cypress Bioscience. Howard Solomon, Chairman
and Chief Executive Officer of Forest said, "We and our partner
Cypress Bioscience are very pleased to receive marketing approval
for Savella, following a first-cycle review, from the FDA.
Fibromyalgia is a chronic and often debilitating condition with a
significant need for new therapies. Savella is a valuable new
treatment for patients afflicted with fibromyalgia. Its
effectiveness was evaluated based upon the multiple symptoms
included in the responder analysis." "This approval is crucial for
Pierre Fabre Laboratories as milnacipran is one of the flagship
products of our portfolio and represents another product of Pierre
Fabre research registered in the United States," said Jean-Pierre
Garnier, Chief Executive Officer of Pierre Fabre SA. Although the
exact mechanism by which Savella improves the symptoms of
fibromyalgia is unknown, some researchers believe that
abnormalities in certain brain neurotransmitters may be central to
fibromyalgia. Savella blocks the reuptake of both norepinephrine
and serotonin, with greater selectivity for the inhibition of
norepinephrine reuptake in vitro. This may be the mechanism by
which Savella acts to improve the symptoms of fibromyalgia. Data
Highlights The clinical development program for Savella was unique
in its use of a composite responder analysis as the primary
endpoint. This endpoint required individual patients to demonstrate
concurrent improvement to multiple validated measures, including
pain (visual analog scale), patient global assessment (patient
global impression of change), and physical function (Short Form-36
Physical Component Summary). The efficacy of Savella was
established in two US pivotal Phase III clinical trials involving
2,084 treated patients (1,460 Savella; 624 placebo), which showed
that Savella demonstrated clinically significant improvements
compared to placebo in treating fibromyalgia. The first study was 6
months in duration and the second study was 3 months in duration.
In both studies, a greater proportion of patients in the Savella
treatment arms (100 mg/day and 200 mg/day) as compared with placebo
treatment, at 3 months, 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. In addition, a greater proportion of patients treated
with Savella as compared with placebo treatment met the criteria
for a treatment response as measured by concurrent improvements in
pain, physical function, and patient global assessment. In both
studies, some patients who rated themselves as globally "much" or
"very much" improved experienced a decrease in pain as early as
week 1 of treatment with a stable dose of Savella that persisted
throughout these studies. The clinical development program
demonstrated that Savella was safe and generally well tolerated.
The most frequently occurring adverse reaction was nausea. Other
common adverse reactions reported in these clinical trials were
constipation, hot flush, hyperhidrosis, vomiting, palpitations,
heart rate increased, dry mouth and hypertension. The majority of
adverse reactions reported were mild to moderate in nature. About
Savella Savella is a dual-reuptake inhibitor that preferentially
blocks the reuptake of norepinephrine with higher potency than
serotonin (in-vitro), two neurotransmitters thought to a play a
central role in the symptoms of fibromyalgia. Savella will be
marketed by Forest and its licensor, Cypress Bioscience. Pierre
Fabre, who originally developed and sells milnacipran outside the
U.S., licensed the rights for North America to Cypress Bioscience.
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.
Important Safety Information Savella is a selective serotonin and
norepinephrine inhibitor (SNRI), similar to some drugs used for the
treatment of depression and other psychiatric disorders.
Antidepressants increased the risk compared to placebo of suicidal
thinking and behavior (suicidality) in children, adolescents, and
young adults in short-term studies of major depressive disorder
(MDD) and other psychiatric disorders. Anyone considering the use
of such drugs in a child, adolescent, or young adult must balance
this risk with the clinical need. Short-term studies did not show
an increase in the risk of suicidality with antidepressants
compared to placebo in adults beyond age 24; there was a reduction
in risk with antidepressants compared to placebo in adults aged 65
and older. Depression and certain other psychiatric disorders are
themselves associated with increases in the risk of suicide.
Patients of all ages who are started on Savella should be monitored
appropriately and observed closely for clinical worsening,
suicidality, or unusual changes in behavior. Families and
caregivers should be advised of the need for close observation and
communication with the prescriber. Savella is not approved for use
in the treatment of major depressive disorder. Savella is not
approved for use in pediatric patients. Savella is contraindicated
in patients taking monoamine oxidase inhibitors (MAOIs)
concomitantly or within 14 days of discontinuing treatment of an
MAOI or in patients with uncontrolled narrow-angle glaucoma.
Development of a potentially life-threatening serotonin syndrome
may occur with agents that inhibit serotonin reuptake, including
Savella, particularly with concomitant use of serotonergic drugs
(including triptans and tramadol) and with drugs which impair
metabolism of serotonin (including MAOIs). The concomitant use of
Savella with serotonin precursors is not recommended. Blood
pressure and heart rate should be monitored prior to initiating
treatment with Savella and periodically throughout treatment.
SNRIs, including Savella, have been associated with reports of
increases in blood pressure and heart rate. Pre-existing
hypertension, tachyarrhythmias and other cardiac diseases should be
treated before starting therapy with Savella. Savella should be
used with caution in patients with significant hypertension or
cardiac disease. For patients who experience a sustained increase
in blood pressure or heart rate while receiving Savella, either
dose reduction or discontinuation should be considered. Savella
should be prescribed with caution in patients with a history of a
seizure disorder, mania or controlled narrow-angle glaucoma.
Savella has been associated with mild elevations of ALT and AST.
Rarely, fulminant hepatitis has been reported in patients treated
with milnacipran. Savella should be discontinued in patients who
develop jaundice or other evidence of liver dysfunction and should
not be resumed unless another cause can be established. Savella
should ordinarily not be prescribed to patients with substantial
alcohol use or evidence of chronic liver disease. As with other
SNRIs and SSRIs withdrawal symptoms have been observed following
discontinuation of milnacipran. A gradual dose reduction is
recommended. Hyponatremia may occur as a result of treatment with
SSRIs and SNRIs, including Savella. Discontinuation should be
considered for patients with symptomatic hyponatremia. SSRIs and
SNRIs, including Savella, may increase the risk of bleeding events.
Patients should be cautioned regarding the risk of bleeding
associated with concomitant use of Savella and NSAIDs, aspirin,
warfarin or other drugs that affect coagulation. Male patients with
a history of obstructive uropathies may experience higher rates of
genitourinary adverse events. Savella is unlikely to be involved in
clinically significant pharmacokinetic drug interactions.
Pharmacodynamic interactions of Savella with other drugs can occur.
Savella contains FD&C Yellow No. 5, which may cause
allergic-type reactions in susceptible persons. In clinical trials,
the most frequently occurring adverse reaction was nausea. The most
commonly occurring adverse reactions (greater than or equal to 5%
and twice that of placebo) were constipation, hot flush,
hyperhidrosis, vomiting, palpitations, heart rate increased, dry
mouth, and hypertension. 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 Report on Form 10-Q, and any
subsequent SEC filings. About Cypress Bioscience Cypress
Bioscience, Inc. provides therapeutics and personalized medicine
services, facilitating improved and individualized patient care.
Cypress addresses 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. This approach to improving patient care creates 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 Savella to
treat fibromyalgia syndrome and its availability in pharmacies by
March 2009. 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 Savella may not achieve market
acceptance. About Pierre Fabre The Pierre Fabre group, France's
second biggest independent pharmaceutical laboratory, achieved a
turnover of 1.7 billion euros in 2007. It employs nearly 10,000
people including 1,400 in the research sector. Its business sectors
are ethical products, healthcare products and dermocosmetics with
the brands Avene, Ducray, A Derma, Galenic, Klorane and Rene
Furterer. The Pierre Fabre group dedicates 25% of its annual
turnover to R&D in five main therapeutic directions: oncology
(PFM's priority R&D sector with 50% of the over all R&D
budget), the Central Nervous System, cardiology, internal medicine
/urology and dermatology. To learn more about the Pierre Fabre
group, visit http://www.pierre-fabre.com/.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
http://photoarchive.ap.org/ DATASOURCE: Forest Laboratories, Inc.;
Cypress Bioscience, Inc. CONTACT: Frank Murdolo, Vice President -
Investor Relations for Forest Laboratories, Inc., +1-212-224-6714,
; or Ciara Kennedy, Sr. Director, Strategy and Corporate
Development or Mary Gieson, Investor Relations, both for Cypress
Bioscience, Inc., +1-858-452-2323 Web Site:
http://www.cypressbio.com/
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