Forest Laboratories And Cypress Bioscience Announce Study Shows Patients Treated With Savella Experience Improvements In Pain And Physical Function

Main Category: Fibromyalgia
Also Included In: Pain / Anesthetics
Article Date: 20 Oct 2009 - 0:00 PDT

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Forest Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (NASDAQ: CYPB) announced that Savella® (milnacipran HCI) 100 mg/day (50 mg twice daily) demonstrated statistically significant and clinically meaningful concurrent improvements in pain, patient global assessment, and physical function, according to results from a large-scale, Phase III clinical trial that will be presented on Tuesday, October 20, 2009, at the American College of Rheumatology Annual Meeting in Philadelphia, PA. 100 mg/day is the recommended dose of Savella. Savella is a selective serotonin and norepinephrine dual reuptake inhibitor (SNRI) that was approved by the U.S. Food and Drug Administration (FDA) earlier this year for the management of fibromyalgia.

Fibromyalgia is a chronic condition characterized by widespread pain and decreased physical function, afflicting as many as six million people in the United States. The study showed statistically significant and clinically meaningful concurrent improvements in pain, patient global assessment, and physical function, among patients receiving Savella treatment of 100 mg/day, as compared to a placebo treatment group, when measured by patient-reported outcomes assessed in composite responder analyses. These results at the 100 mg/day dose are consistent with those of previous clinical trials that have demonstrated the safety and efficacy of Savella at doses of 100 mg/day and 200 mg/day.

"Fibromyalgia is a common, chronic pain disorder that can be associated with an array of debilitating symptoms, so it is important that treatments manage the multiple symptoms of fibromyalgia and improve function," said lead investigator, Lesley M. Arnold, MD, Professor of Psychiatry, University of Cincinnati College of Medicine.

Study Details

This Phase III, double-blind, placebo-controlled trial of 1,025 fibromyalgia patients was designed to further evaluate the efficacy and tolerability of Savella 100 mg/day. Patients were randomized to receive Savella 100 mg/day (n=516) or placebo (n=509) and underwent four to six weeks of flexible dose escalation, followed by 12 weeks of stable-dose treatment followed by a two-week randomized, double-blind discontinuation phase.

This study, like other phase III fibromyalgia studies of Savella used a composite responder analysis as the primary endpoint. This endpoint required individual patients to demonstrate concurrent and clinically meaningful improvements in multiple domains using validated measures, including pain (visual analog scale), patient global assessment (patient global impression of change), and physical function (Short Form-36 Physical Component Summary).

In this study a greater proportion of patients in the Savella treatment arm (100 mg/day) as compared with placebo treatment, at 3 months, experienced at least a 30% reduction in pain from baseline and also rated themselves as "very much improved" or "much improved" based on the patient global assessment. In addition, a greater proportion of patients treated with Savella as compared with placebo treatment met the criteria for a treatment response as measured by concurrent improvements in pain, patient global assessment, and physical function. Some patients who rated themselves as globally "much" or "very much" improved experienced a decrease in pain as early as week 1 of treatment with a stable dose of Savella that persisted throughout the study.

"These data confirm the benefits of Savella in managing fibromyalgia," said Dr. Marco Taglietti, President of Forest Research Institute. "Patients receiving Savella showed simultaneous improvements on multiple measures of fibromyalgia, including pain, patient global assessment, and physical function."

Savella was generally well tolerated in the study. The most common treatment emergent adverse events observed during the placebo-controlled trial included nausea, headache, constipation, hot flush, dizziness, insomnia, hyperhidrosis, palpitations, fatigue, tachycardia, and hypertension. The majority of adverse reactions reported were mild to moderate in nature.

Overall premature discontinuation rates (all causes, including those related to adverse events) through the stable-dose treatment period of the trial were similar for patients receiving 100 mg/day of Savella and patients receiving placebo.

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Savella