Jazz Pharmaceuticals' LUVOX CR Is Now Available for Patients With Social Anxiety Disorder (SAD) and Obsessive Compulsive Disorde
April 14 2008 - 9:00AM
PR Newswire (US)
PALO ALTO, Calif., April 14 /PRNewswire-FirstCall/ -- Jazz
Pharmaceuticals, Inc. (NASDAQ:JAZZ) announced today that Once-A-Day
LUVOX(R) CR (fluvoxamine maleate) Extended-Release Capsules is now
available at pharmacies throughout the United States. LUVOX CR was
recently approved by the U.S. Food and Drug Administration (FDA)
for the treatment of social anxiety disorder (SAD) and obsessive
compulsive disorder (OCD) in adult patients. SAD and OCD are two
difficult-to-treat, underdiagnosed and undertreated anxiety
disorders. (Photo:
http://www.newscom.com/cgi-bin/prnh/20080414/AQM046) Jazz
Pharmaceuticals is dedicated to helping patients suffering from
serious psychiatric and neurological disorders. Jazz
Pharmaceuticals is supporting a number of programs and resources
for SAD and OCD patients and for physicians. These efforts include
education kits, disease education Web sites and diagnostic
screening tools. The company is also introducing CT STEPS(TM), a
novel, Internet-based cognitive behavioral therapy (CBT) program to
help OCD patients. Earlier this month, Jazz Pharmaceuticals' sales
team began communicating with office-based psychiatrists and select
primary care physicians about the unique attributes of LUVOX CR.
These sales professionals will provide samples of LUVOX CR in 100
mg and 150 mg dose strengths that physicians may choose to
distribute to their patients. LUVOX CR incorporates Elan's
proprietary SODAS(R) (Spheroidal Oral Drug Absorption System)
technology, which is designed to minimize peak-to-trough
fluctuations in plasma levels over a 24-hour period. In three Phase
III trials, LUVOX CR was shown to provide tolerability in two
common areas of concern to patients(1,2). In the trials, LUVOX CR
demonstrated a weight-neutral profile with no significant weight
gain or loss(3,4,5,6). In addition, patients taking LUVOX CR had a
low incidence of sexual adverse events in the trials(4). Less than
1 percent of patients treated with LUVOX CR discontinued therapy
due to any individual sexual adverse event(3-6). "We are very
excited about the introduction of LUVOX CR to the United States
market. The availability of LUVOX CR provides physicians with a new
and effective treatment option for the millions of adults in the
United States suffering from SAD and OCD," said Samuel Saks, M.D.,
chief executive officer of Jazz Pharmaceuticals. "Through our
educational efforts, we hope to provide physicians and their
patients with important information about SAD and OCD. As part of
our commitment to helping patients, their families and caregivers,
we are working with advocacy organizations to increase awareness
about these serious and underdiagnosed conditions." Important
Safety Information 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 WARNINGS and PRECAUTIONS). LUVOX CR Capsules
are also contraindicated in patients with a history of
hypersensitivity to fluvoxamine maleate or any of its excipients.
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 percent 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
percent and at least twice that of placebo) included abnormal
ejaculation and anorgasmia. Please see full prescribing information
(http://www.luvoxcr.com/LUVOX-CR-PI.pdf), including boxed warning
for LUVOX CR. About LUVOX CR Once-A-Day LUVOX(R) CR (fluvoxamine
maleate) Extended-Release Capsules was approved by the U.S. Food
and Drug Administration (FDA) in February 2008 on the basis of two
pivotal trials in SAD and one pivotal trial in OCD. LUVOX CR should
be taken once-a-day at bedtime. It can be taken with or without
food and is available in 100 mg and 150 mg dose strengths. 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 efficacy and safety study in patients with SAD. For
more information about LUVOX CR, please visit
http://www.luvoxcr.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(7). SAD affects an estimated 15
million American adults(8). For more information about SAD, please
visit http://www.socialanxietycenter.org/ 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(7). OCD affects approximately 2.2 million American
adults(8). For more information about OCD, please visit
http://www.ocdcenter.org/ 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. For
further information, please visit
http://www.jazzpharmaceuticals.com/. (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(R) is a registered trademark of Solvay
Pharmaceuticals, Inc. (1) Hirschfeld RMA. Long-term side effects of
SSRIs: sexual dysfunction and weight gain. J Clin Psychiatry.
2003;64(suppl 18):20-24. (2) Bruce TJ, Saeed SA. Social anxiety
disorder: a common, underrecognized mental disorder. Am Fam
Physician. 1999;60:2311-2322. (3) 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. (4) LUVOX CR Prescribing
Information. Jazz Pharmaceuticals, Inc. Palo Alto, CA; 2008. (5)
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. (6) 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 Psych. 2003;64:640-647.
(7) American Psychiatric Association. Diagnostic and Statistical
Manual of Mental Disorders, 4th ed, revised. Washington, DC:
American Psychiatric Association; 2000. (8) 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.
http://www.newscom.com/cgi-bin/prnh/20080414/AQM046
http://photoarchive.ap.org/ DATASOURCE: Jazz Pharmaceuticals, Inc.
CONTACT: Becky Lauer of MS&L, office, +1-212-468-4125, or cell,
+1-917-304-6138, , for Jazz Pharmaceuticals, Inc. Web site:
http://www.jazzpharmaceuticals.com/ http://www.luvoxcr.com/
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