Once-Daily Fluvoxamine Approved for Treatment of SAD and OCD
Susan Jeffrey
March 3, 2008 ? Jazz Pharmaceuticals, Inc. has announced that they have received US Food and Drug Administration (FDA) approval for a once-daily extended-release formulation of fluvoxamine maleate (Luvox CR) for the treatment of social anxiety disorder (SAD) and obsessive-compulsive disorder (OCD).
"We are pleased to have FDA approval of this new, effective treatment option for patients in the United States with SAD and OCD, and are proceeding toward launch by the end of this quarter," said Samuel Saks, MD, chief executive officer of Jazz Pharmaceuticals, in a statement issued by the company February 28.
The agent is a selective serotonin reuptake inhibitor (SSRI) that incorporates proprietary technology (Spheroidal Oral Drug Absorption System [SODAS], from Elan), which minimizes peak-to-trough plasma-level fluctuations over 24 hours, the statement notes. In separate clinical trials after 12 weeks of treatment, the once-daily formulation provided statistically significant improvement over placebo in SAD symptoms measured using the Liebowitz Social Anxiety Scale, and in OCD symptoms measured using the Yale-Brown Obsessive Compulsive Scale.
"Physicians have been using immediate-release fluvoxamine for years to treat OCD patients," John H. Greist, MD, clinical professor of psychiatry at the University of Wisconsin Medical School, in Madison, said in the company statement. Having an extended-release formulation, he said, "offers patients with SAD and OCD an additional option."
The statement adds that the FDA evaluated a data package involving some 600 patients from 3 clinical trials with positive outcomes: 2 for SAD (J Clin Psychopharmacol. 2004;24:118-125 and 2004;24:49-55.) and 1 for OCD (J Clin Psychiatry. 2003;64:640-647).
The new formulation will be available in 100 mg and 150 mg doses.
Jazz Pharmaceuticals licensed the right to market this formulation from Solvay Pharmaceuticals in January 2007. The approval includes a postmarketing commitment to conduct a safety and efficacy study in adolescent patients with SAD and a long-term safety and efficacy study, also in patients with SAD. The New Drug Application is being transferred to Jazz Pharmaceuticals, the statement notes.
"We're excited about new treatment options ? both medications and psychological ? to help patients with these chronic and undertreated anxiety disorders," Jerilyn Ross, president and CEO of the Anxiety Disorders Association of America, is quoted as saying in the company statement. "Having treatment options benefits the patient, and that's what is most important."
Susan Jeffrey
March 3, 2008 ? Jazz Pharmaceuticals, Inc. has announced that they have received US Food and Drug Administration (FDA) approval for a once-daily extended-release formulation of fluvoxamine maleate (Luvox CR) for the treatment of social anxiety disorder (SAD) and obsessive-compulsive disorder (OCD).
"We are pleased to have FDA approval of this new, effective treatment option for patients in the United States with SAD and OCD, and are proceeding toward launch by the end of this quarter," said Samuel Saks, MD, chief executive officer of Jazz Pharmaceuticals, in a statement issued by the company February 28.
The agent is a selective serotonin reuptake inhibitor (SSRI) that incorporates proprietary technology (Spheroidal Oral Drug Absorption System [SODAS], from Elan), which minimizes peak-to-trough plasma-level fluctuations over 24 hours, the statement notes. In separate clinical trials after 12 weeks of treatment, the once-daily formulation provided statistically significant improvement over placebo in SAD symptoms measured using the Liebowitz Social Anxiety Scale, and in OCD symptoms measured using the Yale-Brown Obsessive Compulsive Scale.
"Physicians have been using immediate-release fluvoxamine for years to treat OCD patients," John H. Greist, MD, clinical professor of psychiatry at the University of Wisconsin Medical School, in Madison, said in the company statement. Having an extended-release formulation, he said, "offers patients with SAD and OCD an additional option."
The statement adds that the FDA evaluated a data package involving some 600 patients from 3 clinical trials with positive outcomes: 2 for SAD (J Clin Psychopharmacol. 2004;24:118-125 and 2004;24:49-55.) and 1 for OCD (J Clin Psychiatry. 2003;64:640-647).
The new formulation will be available in 100 mg and 150 mg doses.
Jazz Pharmaceuticals licensed the right to market this formulation from Solvay Pharmaceuticals in January 2007. The approval includes a postmarketing commitment to conduct a safety and efficacy study in adolescent patients with SAD and a long-term safety and efficacy study, also in patients with SAD. The New Drug Application is being transferred to Jazz Pharmaceuticals, the statement notes.
"We're excited about new treatment options ? both medications and psychological ? to help patients with these chronic and undertreated anxiety disorders," Jerilyn Ross, president and CEO of the Anxiety Disorders Association of America, is quoted as saying in the company statement. "Having treatment options benefits the patient, and that's what is most important."
