Forest Laboratories, Inc. and Cypress Bioscience, Inc. Announce Revised Timing for Commercial Availability of Savella(TM)
March 06 2009 - 8:00AM
PR Newswire (US)
NEW YORK and SAN DIEGO, March 6, 2009 /PRNewswire-FirstCall/ --
Forest Laboratories, Inc. (NYSE:FRX) and Cypress Bioscience, Inc.
(NASDAQ:CYPB) announced today that they expect to ship Savella(TM)
(milnacipran HCl), a selective serotonin and norepinephrine
reuptake inhibitor for the management of fibromyalgia, to
wholesalers and pharmacies by mid 2009. Savella was approved by the
U. S. Food and Drug Administration (FDA) on January 14, 2009 and
was originally expected to be available in March 2009. The
companies submitted a minor post-approval cosmetic formulation
change for FDA approval. A response from the FDA is anticipated no
later than May, 2009. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) About
Savella Savella is approved 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 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
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
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 that we expect to ship Savella
(milnacipran HCl) to wholesalers and pharmacies by mid 2009 and
that we expect a response from the FDA in May 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/FORESTLOGODATASOURCE:
Forest Laboratories, Inc.; Cypress Bioscience, Inc. CONTACT: Frank
J. Murdolo, Vice President, Investor Relations, Forest
Laboratories, Inc., +1-212-224-6714, ; or Ciara Kennedy, Sr.
Director, Strategy and Corporate Development, or Mary Gieson,
Investor Relations, , both of Cypress Bioscience, Inc.,
+1-858-452-2323 Web Site: http://www.cypressbio.com/
http://www.frx.com/
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