/C O R R E C T I O N -- Jazz Pharmaceuticals, Inc./
In the news release, FDA Approves Luvox(R) CR (Fluvoxamine Maleate)
Extended-Release Capsules for the Treatment of Social Anxiety Disorder (SAD)
and Obsessive Compulsive Disorder (OCD), issued earlier today by Jazz
Pharmaceuticals, Inc. (Nasdaq: JAZZ) over PR Newswire, we are advised by the
company that in the "Important Safety Information" section, in the second
paragraph, first and second sentences, the symbol ">" should have been
"greater than or equal to" rather than ">" as incorrectly transmitted by
PR Newswire.
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FDA Approves Luvox(R) CR (Fluvoxamine Maleate) Extended-Release Capsules for
the Treatment of Social Anxiety Disorder (SAD) and Obsessive Compulsive
Disorder (OCD)
PALO ALTO, Calif., Feb. 28 /PRNewswire-FirstCall/ -- Today, Jazz
Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced that the U.S. Food and Drug
Administration (FDA) has approved Once-A-Day LUVOX CR (fluvoxamine maleate)
Extended-Release Capsules for the treatment of social anxiety disorder (SAD)
and obsessive compulsive disorder (OCD) in adults. LUVOX CR is a selective
serotonin reuptake inhibitor (SSRI) that incorporates Elan's proprietary
SODAS(R) (Spheroidal Oral Drug Absorption System) technology designed to
minimize peak-to-trough plasma level fluctuations over a 24-hour period.
In clinical trials at the primary endpoint of 12 weeks, Once-A-Day LUVOX
CR provided statistically significant improvement vs. placebo in SAD symptoms
as measured by the LSAS (Liebowitz Social Anxiety Scale) and statistically
significant improvement vs. placebo in OCD symptoms as measured by the Y-BOCS
(Yale-Brown Obsessive Compulsive Scale)(1) (2) (3) (4).
"We are pleased to have FDA approval of this new, effective treatment
option for patients in the United States with SAD and OCD and our proceeding
towards launch by the end of this quarter," said Samuel Saks, M.D., chief
executive officer of Jazz Pharmaceuticals. "As part of our commitment to
patients with these two serious and widely under-recognized anxiety disorders,
we are working with patient advocacy organizations to raise awareness about
these conditions and encourage patients to get accurately diagnosed."
"The approval of Once-A-Day LUVOX CR (fluvoxamine maleate)
Extended-Release Capsules for social anxiety disorder and obsessive compulsive
disorder is important for the 15 million Americans with SAD and the 2.2
million Americans with OCD, two underdiagnosed and undertreated anxiety
disorders," said John H. Greist, M.D., distinguished senior scientist, Madison
Institute of Medicine and clinical professor of psychiatry, University of
Wisconsin Medical School. "Physicians have been using immediate-release
fluvoxamine for years to treat OCD patients. Now having Once-A-Day LUVOX CR
(fluvoxamine maleate) Extended-Release Capsules offers patients with SAD and
OCD an additional option."
The FDA evaluated a data package involving approximately 600 patients
worldwide that included three clinical trials with positive outcomes
evaluating the efficacy and safety of LUVOX CR. These studies were:
Social Anxiety Disorder
-- Davidson, Jonathan, et al. Fluvoxamine-controlled release formulation
for the treatment of generalized social anxiety disorder. J Clin
Psychopharmacol 2004; 24:118-125.
-- Westenberg, Herman, et al. A double-blind, placebo-controlled study of
controlled-release fluvoxamine for the treatment of generalized social
anxiety disorder. J Clin Psychopharmacol. 2004; 24:49-55.
Obsessive Compulsive Disorder
-- Hollander, Eric, et al. A double-blind, placebo-controlled study of
the efficacy and safety of controlled-release fluvoxamine in patients
with obsessive-compulsive disorder. J Clin Psychiatry. 2003;
64:640-647.
"SAD and OCD are serious, yet treatable conditions," said Jerilyn Ross,
M.A., L.I.C.S.W., president and CEO, Anxiety Disorders Association of America
(ADAA). "We're excited about new treatment options -- both medications and
psychological -- to help patients with these chronic and undertreated anxiety
disorders. Having treatment options benefits the patient, and that's what is
most important."
LUVOX CR will be available in 100 mg and 150 mg dose strengths. Over the
next several weeks, Jazz Pharmaceuticals will continue to work closely with
Elan on the manufacturing of LUVOX CR for commercial launch.
In January 2007, Jazz Pharmaceuticals licensed the right to market
Once-A-Day LUVOX CR (fluvoxamine maleate) Extended-Release Capsules in the
U.S.
from Solvay Pharmaceuticals. The license agreement provides for Jazz
Pharmaceuticals to pay Solvay Pharmaceuticals $20 million as a result of the
approval of LUVOX CR for both SAD and OCD and the approved expiry dating of
the product.
The approval of LUVOX CR includes a post marketing commitment to conduct a
safety and efficacy study in adolescent patients with SAD and a long-term
safety and efficacy study in patients with SAD. The NDA for LUVOX CR is being
transferred to Jazz Pharmaceuticals.
For more information about LUVOX CR, please visit
http://www.JazzPharmaceuticals.com
Social Anxiety Disorder
SAD or social phobia is characterized by the fear and avoidance of social
or performance situations where patients feel that others may scrutinize them
and they may embarrass themselves. Patients experience physical symptoms of
anxiety, including blushing, sweating, trembling and nausea. (5) SAD affects
an estimated 15 million American adults. (6)
Obsessive Compulsive Disorder
OCD is a chronic and debilitating anxiety disorder that is characterized
by recurrent, unwanted thoughts (obsessions) and/or repetitive behaviors
(compulsions) that are severe enough to cause significant impairment.
Patients are compelled to perform repetitive behaviors such as hand washing,
counting, checking or cleaning with the goal of preventing obsessive thoughts
or making them go away.5 OCD affects approximately 2.2 million American
adults.6
Important Safety Information
Antidepressants can increase suicidal thoughts and behaviors in children,
adolescents and young adults. Patients should call their doctor right away if
they experience new or worsening depression symptoms, unusual changes in
behavior, or thoughts of suicide.
In clinical trials, the most commonly observed adverse events with an
incidence of greater than or equal to 5% and at least twice that of placebo
were nausea, somnolence, asthenia, diarrhea, anorexia, tremor, and sweating.
Overall, these side effects were mild to moderate in severity and transient in
nature. Other common adverse events with an incidence of greater than or equal
to 5% and at least twice that of placebo included abnormal ejaculation and
anorgasmia.
The use of alosetron, tizanidine, thioridazine, or pimozide with LUVOX CR
Capsules is contraindicated. The use of MAO inhibitors in combination with
LUVOX CR Capsules or within 14 days of discontinuing treatment with LUVOX CR
Capsules is contraindicated. (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS
in full prescribing information.) LUVOX CR Capsules are also contraindicated
in patients with a history of hypersensitivity to fluvoxamine maleate or any
of its excipients.
Clinical Measures
LSAS: A clinician-rated, 24-item scale used to assess the range of
difficulties in social interaction (11 questions) and performance situations
(13 questions) that a patient with SAD may have.
Y-BOCS: A clinician-rated, 10-item scale used to rate the severity of
obsessive compulsive symptoms and to monitor improvement during treatment.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals, Inc. is a specialty pharmaceutical company focused
on identifying, developing and commercializing innovative products to meet
unmet medical needs in neurology and psychiatry. Jazz Pharmaceuticals will
host an Investor Day on March 13, 2008 beginning at 10:00 a.m. Eastern
Time/7:00 a.m. Pacific Time. The event will be available by live audio
webcast, and the accompanying presentation materials will also be available on
the investor relations section of Jazz Pharmaceuticals' website. For further
information, please visit http://www.JazzPharmaceuticals.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act
of 1995
This press release contains forward-looking statements, including, but not
limited to, statements related to the planned commercial launch of LUVOX CR
and Jazz Pharmaceuticals' continuing efforts, including manufacturing to
prepare for commercial launch. Words and phrases such as "will," "are
proceeding" and similar expressions are intended to identify forward-looking
statements. These forward-looking statements are based upon Jazz
Pharmaceuticals' current expectations. Forward-looking statements involve
significant risks and uncertainties. Jazz Pharmaceuticals' actual results and
the timing of events could differ materially from those anticipated in such
forward-looking statements as a result of these risks and uncertainties, which
include, without limitation, risks related to when or whether commercial
launch of LUVOX CR will occur, Jazz Pharmaceuticals' ability to attain market
acceptance of LUVOX CR by physicians, patients and third party payors, Jazz
Pharmaceuticals' dependence on single source suppliers and manufacturers, and
scaling up manufacturing of LUVOX CR to commercial capacity. These and other
risk factors are discussed under "Risk Factors," in the Quarterly Report on
Form 10-Q for the quarter ended September 30, 2007 filed by Jazz
Pharmaceuticals with the Securities and Exchange Commission on November 9,
2007. Jazz Pharmaceuticals undertakes no duty or obligation to update any
forward-looking statements contained in this release as a result of new
information, future events or changes in its expectations.
(C)2008 Jazz Pharmaceuticals, Inc.
SODAS(R) is a registered trademark of Elan Pharma International Limited,
Ireland, a subsidiary of Elan Corporation, plc (NYSE; ELN)
LUVOX is a registered trademark of Solvay Pharmaceuticals, Inc.
(1) Davidson J, Yaryura-Tobias J, DuPont R, et al. Fluvoxamine-controlled
release formulation for the treatment of generalized social anxiety
disorder. J Clin Psychopharmacol. 2004;24:118-125.
(2) Hollander E, Koran LM, Goodman WK, et al. A double-blind,
placebo-controlled study of the efficacy and safety of
controlled-release fluvoxamine in patients with obsessive-compulsive
disorder. J Clin Psychiatry. 2003;64:640-647.
(3) LUVOX CR Prescribing Information. Jazz Pharmaceuticals, Inc., Palo
Alto, CA;2008.
(4) Westenberg HGM, Stein DJ, Yang H, et al. A double-blind
placebo-controlled study of controlled release fluvoxamine for the
treatment of generalized social anxiety disorder. J Clin
Psychopharmacol.2004;24:49-55.
(5) American Psychiatric Association. Diagnostic and Statistical Manual
of Mental Disorders, 4th ed, revised. Washington, DC: American
Psychiatric Association; 2000.
(6) Kessler RC, et al. Arch Gen Psychiatry. 2005; 62:593-602/ NIMH
Website:
http://www.nimh.nih.gov/health/publications/the-numbers-count-mental-
disorders-in-america.shtml#Anxiety, Date accessed December 14, 2007.
SOURCE Jazz Pharmaceuticals, Inc.
investors, Jim Karrels of Jazz Pharmaceuticals, Inc., +1-650-496-2800,
investorinfo@jazzpharmaceuticals.com; or media, Becky Lauer of MS&L,
+1-212-468-4125, becky.lauer@mslpr.com for Jazz Pharmaceuticals, Inc.
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