Forest Laboratories, Inc. and Cypress Bioscience, Inc. Announce Commercial Availability of Savella(TM)
NEW YORK and SAN DIEGO, April 20, 2009 /PRNewswire-FirstCall/ -- Forest
Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (Nasdaq: CYPB)
announced today that Savella(TM) (milnacipran HCl), a selective serotonin and
norepinephrine dual reuptake inhibitor approved for the management of
fibromyalgia, will be shipped to wholesalers on April 24th and will be
available at pharmacies beginning on April 28th. After Savella was approved
by the U.S. Food and Drug Administration (FDA) on January 14, 2009, the
companies submitted a minor post-approval cosmetic formulation change to the
FDA which now has been approved.
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
serotonin, 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.
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. 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 with 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.
In clinical trials, the most frequently occurring adverse reactions
(greater than or equal to 5% and greater than placebo)were nausea, headache,
constipation, dizziness, 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 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
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 including statements
about the potential of Savella to treat fibromyalgia syndrome and that we
expect Savella (milnacipran HCl) to be at pharmacies by April 28, 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 www.pierre-fabre.com.
SOURCE: Forest Laboratories, Inc.; Cypress Bioscience, Inc.
CONTACT:
Frank Murdolo, Vice President - Investor Relations of Forest
Laboratories, Inc.
+1-212-224-6714
frank.murdolo@frx.com
or
Ciara Kennedy,
Sr. Director, Strategy and Corporate Development
or
Mary Gieson, Investor
Relations
mgieson@cypressbio.com
both of Cypress Bioscience, Inc.
+1-858-452-2323
Web Site:
http://www.frx.com
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Pat
Draper, a Virginia POPAN state leader, was recently interviewed by
Roanoke News Channel 7 about her experience with fibromyalgia. She
also gave information about a public forum on fibromyalgia in which
she presented. The event, "Real Women-Real Pain Facts and Realities of
Fibromyalgia,” was held on May 12, 2008, National Fibromyalgia
Awareness Day, in Salem, VA. A video clip of Pat's interview is
available at
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