Forest Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience,
Inc. (NASDAQ: CYPB) today announced that Savella® (milnacipran HCI)
100 mg/day (50 mg twice daily) demonstrated statistically
significant and clinically meaningful concurrent improvements in
pain, patient global assessment, and physical function, according
to results from a large-scale, Phase III clinical trial that will
be presented on Tuesday, October 20, 2009, at the American College
of Rheumatology Annual Meeting in Philadelphia, PA. 100 mg/day is
the recommended dose of Savella. Savella is a selective serotonin
and norepinephrine dual reuptake inhibitor (SNRI) that was approved
by the U.S. Food and Drug Administration (FDA) earlier this year
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 study showed statistically
significant and clinically meaningful concurrent improvements in
pain, patient global assessment, and physical function, among
patients receiving Savella treatment of 100 mg/day, as compared to
a placebo treatment group, when measured by patient-reported
outcomes assessed in composite responder analyses. These results at
the 100 mg/day dose are consistent with those of previous clinical
trials that have demonstrated the safety and efficacy of Savella at
doses of 100 mg/day and 200 mg/day.
"Fibromyalgia is a common, chronic pain disorder that can be
associated with an array of debilitating symptoms, so it is
important that treatments manage the multiple symptoms of
fibromyalgia and improve function," said lead investigator, Lesley
M. Arnold, MD, Professor of Psychiatry, University of Cincinnati
College of Medicine.
Study Details
This Phase III, double-blind, placebo-controlled trial of 1,025
fibromyalgia patients was designed to further evaluate the efficacy
and tolerability of Savella 100 mg/day. Patients were randomized to
receive Savella 100 mg/day (n=516) or placebo (n=509) and underwent
four to six weeks of flexible dose escalation, followed by 12 weeks
of stable-dose treatment followed by a two-week randomized,
double-blind discontinuation phase.
This study, like other phase III fibromyalgia studies of Savella
used a composite responder analysis as the primary endpoint. This
endpoint required individual patients to demonstrate concurrent and
clinically meaningful improvements in multiple domains using
validated measures, including pain (visual analog scale), patient
global assessment (patient global impression of change), and
physical function (Short Form-36 Physical Component Summary).
In this study a greater proportion of patients in the Savella
treatment arm (100 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, patient global
assessment, and physical function. 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 the study.
“These data confirm the benefits of Savella in managing
fibromyalgia,” said Dr. Marco Taglietti, President of Forest
Research Institute. “Patients receiving Savella showed simultaneous
improvements on multiple measures of fibromyalgia, including pain,
patient global assessment, and physical function.”
Savella was generally well tolerated in the study. The most
common treatment emergent adverse events observed during the
placebo-controlled trial included nausea, headache, constipation,
hot flush, dizziness, insomnia, hyperhidrosis, palpitations,
fatigue, tachycardia, and hypertension. The majority of adverse
reactions reported were mild to moderate in nature.
Overall premature discontinuation rates (all causes, including
those related to adverse events) through the stable-dose treatment
period of the trial were similar for patients receiving 100 mg/day
of Savella and patients receiving placebo.
About Savella
Savella was approved by the FDA on January 14, 2009, for the
management of fibromyalgia, a chronic condition characterized by
widespread pain and decreased physical function that afflicts as
many as six million people in the United States. Savella is a
dual-reuptake inhibitor that, in vitro, preferentially blocks the
reuptake of norepinephrine with higher potency than for serotonin,
two neurotransmitters thought to a play a central role in the
symptoms of fibromyalgia. Savella is 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.
Please visit www.savella.com for more information.
Important Safety Information
Savella is a selective serotonin and norepinephrine reuptake
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, especially during the initial few
months of drug therapy or at times of dose changes, either
increases or decreases. 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.
Contraindications
Savella is contraindicated in patients taking monoamine oxidase
inhibitors (MAOIs) concomitantly or within 14 days of discontinuing
treatment with an MAOI. There have been reports of serious,
sometimes fatal, reactions in patients started on an MAOI who were
receiving or had recently discontinued a serotonin reuptake
inhibitor. At least 5 days should be allowed after stopping Savella
before starting an MAOI.
Savella is contraindicated in patients with uncontrolled
narrow-angle glaucoma and should be used with caution in patients
with controlled narrow-angle glaucoma. In clinical trials, Savella
was associated with an increased risk of mydriasis.
Warnings and Precautions
Prescriptions for Savella should be written for the smallest
quantity of tablets, consistent with good patient management, in
order to reduce the risk of overdose.
Development of a potentially life-threatening serotonin syndrome
or neuroleptic malignant syndrome (NMS)-like reactions have been
reported with SSRIs and SNRIs alone, including Savella, but
particularly with concomitant use of serotonergic drugs (including
triptans), drugs that impair metabolism of serotonin (including
MAOIs), or antipsychotics or other dopamine antagonists. The
management of these reactions should include immediate
discontinuation of Savella and the concomitant agent and supportive
symptomatic treatment. The concomitant use of Savella with
serotonin precursors is not recommended.
SNRIs, including Savella, have been associated with
cardiovascular effects, including cases of elevated blood pressure,
requiring immediate treatment. In clinical trials, sustained
increases in systolic and diastolic blood pressure occurred more
frequently in Savella-treated patients compared to placebo. Among
patients who were non-hypertensive at baseline, approximately twice
as many patients receiving Savella, vs placebo, became hypertensive
at the end of the study. Clinically significant increases in pulse
(≥20 bpm) occurred more frequently in Savella-treated than
placebo-treated patients. Blood pressure and heart rate should be
monitored prior to initiating treatment with Savella and
periodically throughout treatment. 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. Concomitant use of Savella with drugs that increase blood
pressure and pulse has not been evaluated, and such combinations
should be used with caution. 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 seizure disorder or mania.
Savella has been associated with mild elevations of ALT and AST
(1 to 3 times the upper limit of normal). Rarely, reports of
serious liver injury, including fulminant hepatitis, have 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.
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. Elderly patients may be at greater risk.
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.
Savella can affect urethral resistance and micturition. Caution
is advised in the use of Savella in patients with a history of
dysuria, notably in male patients with a history of obstructive
uropathies as these patients may experience higher rates of
genitourinary adverse events.
Savella should ordinarily not be prescribed to patients with
substantial alcohol use or evidence of chronic liver disease.
Use in Specific Populations
There are no adequate and well-controlled studies in pregnant
women. Savella should be used during pregnancy only if the
potential benefit justifies the potential risk to the fetus.
Adverse Reactions
In clinical trials, the most frequently occurring adverse
reaction was nausea (37% vs 20% for placebo). The most commonly
occurring adverse reactions (≥5% and greater than placebo) were
headache (18% vs 14%), constipation (16% vs 4%), dizziness (10% vs
6%), insomnia (12% vs 10%), hot flush (12% vs 2%), hyperhidrosis
(9% vs 2%), vomiting (7% vs 2%), palpitations (7% vs 2%), heart
rate increased (6% vs 1%), dry mouth (5% vs 2%), and hypertension
(5% vs 2%).
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 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. Current products include Savella®
(milnacipran HCI) and the Avise PGSM and Avise MCVSM therapeutic
monitoring, diagnostic and prognostic tests for rheumatoid
arthritis.
For more information about Cypress, please visit the Company's
website at www.cypressbio.com.
This press release, as well as Cypress' SEC filings and website
at www.cypressbio.com, contain forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Such statements include, but are not limited to, statements
regarding the potential of Savella to treat fibromyalgia and the
ability of Savella to provide meaningful improvements in pain,
patient global assessment and physical function among patients
being treated for 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,
its most recent Quarterly Report on Form 10-Q and any subsequent
SEC filings and including, but limited to, that more detailed
analysis of the trial results may not be favorable or may lead to
different conclusions, that Savella’s efficacy for treating
fibromyalgia may be perceived differently among doctors, patients
and third-party payors than the trial results and that Savella may
not meet with market acceptance. These forward-looking statements
speak only as of the date hereof and Cypress disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise, except as required by law.
About Pierre Fabre
Pierre Fabre group, France's second biggest independent
pharmaceutical laboratory, achieved a turnover of 1.75 billion
euros in 2008. Approximately 10,000 people including 1,400 in the
research sector, are employed Its therapeutic are ethical products,
healthcare products and dermocosmetics with the brands Avene,
Ducray, A Derma, Galenic, Klorane and Rene Furterer. In 2008,
Pierre Fabre Medicament dedicated 33% of its annual turnover to
R&D in five main therapeutic directions: oncology, the Central
Nervous System, cardiology, internal medicine/urology and
dermatology.
To learn more about the Pierre Fabre group, visit
www.pierre-fabre.com.
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