Monday, April 14, 2008

Jazz Pharmaceuticals' Luvox CR Is Now Available for Patients With Social Anxiety Disorder (SAD) and Obsessive Compulsive Disorder (OCD)

Jazz Pharmaceuticals, Inc. 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.

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."

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