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I found an article about the FDA approving the intake of Fluvoxamine. It supposedly is highly effective for curing SAD and OCD too! What do you guys think of this?
I realize that the link I have provided does not directly take you to the article, therefore I will past its content here. If you wish to see where the article is originally located you will have to type the headline in the google search engine. You can also read about the study highlights of this product.
Fluvoxamine Approved for Treatment of SAD and OCD
March 7, 2008 — Jazz Pharmaceuticals, Inc, has announced that it has 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 and obsessive-compulsive disorder.
"We are pleased to have FDA approval of this new, effective treatment option for patients in the United States with SAD [social anxiety disorder] and OCD [obsessive-compulsive disorder] 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 on February 28.
The agent is a selective serotonin reuptake inhibitor that incorporates proprietary technology (the Spheroidal Oral Drug Absorption System; Elan Corp), which minimizes peak-to-trough plasma-level fluctuations for 24 hours, the statement notes. In separate clinical trials after 12 weeks of treatment, the once-daily formulation provided statistically significant improvement vs placebo in social anxiety disorder symptoms measured with use of the Liebowitz Social Anxiety Scale and in obsessive-compulsive disorder symptoms measured by 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, Wisconsin, 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 social anxiety disorder (Davidson J, Yaryura-Tobias J, DuPont R, et al. J Clin Psychopharmacol. 2004;24:118-125 and Westenberg HG, Stein DJ, Yang H, et al. J Clin Psychopharmacol. 2004;24:49-55) and 1 for obsessive-compulsive disorder (Hollander E, Koran LM, Goodman WK, et al. 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 social anxiety disorder and a long-term safety and efficacy study, also in patients with social anxiety disorder. 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."
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