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May 4, 2004
Paxil CR May Offer Help for the Millions of Americans With the Chronic
Disorder
NEW YORK, May 4 /PRNewswire-FirstCall/ -- GlaxoSmithKline's (NYSE: GSK) Paxil CR(R) (paroxetine HCl) Controlled-Release Tablets are associated with a significant reduction in symptoms and are generally well-tolerated in fibromyalgia patients, according to results from a new placebo-controlled trial released today. The study, presented at the 157th annual meeting of the American Psychiatric Association (APA) in New York, is the first to look at the benefits of Paxil CR in fibromyalgia -- a chronic disorder for which there is no FDA-approved treatment.
"Fibromyalgia can be an extremely debilitating illness. Unfortunately,
with no known cure or well-studied treatments, sufferers are often left to manage their symptoms with a trial-and-error approach," said Prakash Masand, M.D., a study investigator and consulting professor of psychiatry at Duke University School of Medicine. "The results of this study are encouraging because they provide clinical trial evidence that controlled-release paroxetine may reduce the symptoms of fibromyalgia."
Fibromyalgia is a chronic illness characterized by widespread
musculoskeletal aches, pain and stiffness, soft tissue tenderness, general fatigue and sleep disturbances. The most common sites of pain (called "tender points") include the neck, back, shoulders, pelvic girdle, hands, knees, elbows and hip joints, but any body part can be involved. Patients experience physical and emotional symptoms that come and go over time.
Fibromyalgia affects more women than men and is seen in all age groups, although in most patients, the illness generally begins during their 20s or 30s.
Controlled-Release Paroxetine Superior to Placebo
In a 12-week randomized, placebo-controlled, double blind study of 180
patients with a diagnosis of fibromyalgia, 116 patients were randomized to receive either controlled-release paroxetine, with a dose ranging from 12.5 mg to 62.5 mg daily or placebo. The mean dose given was 39.1 mg. The primary efficacy measure was a 25 percent or greater reduction in scores on the Fibromyalgia Impact Questionnaire (FIQ) from randomization to end of treatment and included the Clinical Global Impression (CGI)-Improvement (I) and Severity (S) measures and the Visual Analogue Scale (VAS) for pain. Data was analyzed using Intent to Treat (ITT) with Last Observation Carried Forward (LOCF) and Kaplan Meier survival models.
The study demonstrated that significantly more patients in the controlled-release paroxetine group (57 percent) responded to treatment as shown by a reduction of at least 25 percent on the FIQ, superior to placebo (33 percent) over the 12-week study. Likewise, patients receiving controlled-release paroxetine were more likely to have CGI-I scores of 1 or 2 (much improved or very much improved) (58 percent) compared to patients on placebo (25 percent).
There was no significant difference between the controlled-release paroxetine and placebo groups on the VAS pain scores. In this study, side effects were generally mild, with drowsiness (26 versus 6 percent), dry mouth (36 versus 9 percent) and female genital disorder
(8 versus 2 percent) reported more frequently in the controlled-release paroxetine group.
Controlled-Release Paxil CR Tablets
Paxil CR(R) (paroxetine HCl) Controlled-Release Tablets offers the proven efficacy of paroxetine in a Geomatrix oral drug delivery system. The tablet is a multi-layered formulation that controls dissolution and allows absorption of the drug further down in the small intestine. Paxil CR offers flexible dosing with three dosing strengths: 12.5 mg, 25 mg, and 37.5 mg. Geomatrix technology is licensed from SkyePharma PLC (Nasdaq: SKYE; LSE: SKP). Paxil CR is
currently approved for the treatment of depression, panic disorder,
premenstrual dysphoric disorder (PMDD) and social anxiety disorder.
Most common adverse events (incidence of 5 percent or greater incidence for Paxil CR and at least twice that for placebo) in studies for major depressive disorder, panic disorder, PMDD and social anxiety disorder include infection, trauma, nausea, diarrhea, dry mouth, constipation, decreased appetite, somnolence, dizziness, decreased libido, tremor, yawning, sweating, abnormal vision, asthenia, insomnia, abnormal ejaculation, female genital disorders and impotence. Patients should not be abruptly discontinued from
antidepressant medication, including Paxil CR. Concomitant use of Paxil CR in patients taking monoamine oxidase inhibitors (MAOIs) or thioridazine is contraindicated.
For more information on Paxil CR log on to http://www.paxilcr.com, or for patients who are being treated with Paxil CR, visit CRBalance.com.
About GlaxoSmithKline
GlaxoSmithKline -- one of the world's leading research-based
pharmaceutical and healthcare companies -- is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
Company information line: 1-888-825-5249. Web site address: http://www.gsk.com.
SOURCE: GlaxoSmithKline
Web Site: http://www.gsk.com http://www.paxilcr.com
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