FDA Approves Third Medication for Fibromyalgia

The long-awaited day when the FDA would approve milnacipran for the treatment of fibromyalgia has finally arrived.  Forest Laboratories, Inc. and Cypress Bioscience, Inc. announced that the newly approved medication will be marketed under the brand name Savella. 

Savella is a selective serotonin and norepinephrine dual reuptake inhibitor (SNRI).  It blocks the reuptake of both norepinephrine and serotonin, with greater selectivity for the inhibition of norepinephrine reuptake in vitro.  These two neurotransmitters are thought to a play a central role in the symptoms of fibromyalgia.  The studies showed that Savella doses of 100 mg/day and 200 mg/day demonstrated statistically significant and clinically meaningful concurrent improvements in pain, patient global assessment, and physical function.

Until now, milnacipran has not been available in the United States, although it has been used for a number of years in other countries for the treatment of depression.  Therefore, doctors have not been able to prescribe Savella, even off label.  So this truly is a brand new medication for FM patients in the U.S.  Savella is expected to be available in U.S. pharmacies by March 2009. 

Savella Clinical Trials

The clinical development program for Savella was unique because it considered a patient to be a responder to therapy only if they demonstrated concurrent clinically significant changes in multiple aspects of their fibromyalgia, including pain, patient global assessment and physical function.  Savella is the first drug approved for FM that used a composite responder analysis.

The efficacy of Savella was established in two US pivotal Phase III clinical trials involving 2,084 treated patients (1,460 Savella; 624 placebo), which showed that Savella demonstrated clinically significant improvements compared to placebo in treating fibromyalgia. The first study was six months in duration and the second study was three months in duration.

In both studies, a greater proportion of patients in the Savella treatment arms (100 mg/day and 200 mg/day) as compared with placebo treatment, at three 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, physical function, and patient global assessment. In both studies, some patients who rated themselves as globally "much" or "very much" improved experienced a decrease in pain as early as week one of treatment with a stable dose of Savella that persisted throughout these studies.

The clinical development program demonstrated that Savella was safe and generally well tolerated. The most frequently occurring adverse reaction was nausea. Other common adverse reactions reported in these clinical trials were constipation, hot flush, hyperhidrosis, vomiting, palpitations, heart rate increased, dry mouth and hypertension. The majority of adverse reactions reported were mild to moderate in nature.