Jazz Pharmaceuticals, Inc. announced that the US 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 (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).

"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:

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 US 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.

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.