Staff Writer

Savella, a newly approved treatment for fibromyalgia, will be hitting U.S. pharmacy shelves in March and likely will be facing some stiff competition.

But the companies that will market Savella, Forest Laboratories Inc. and Cypress Bioscience Inc., said their product - approved by the FDA Wednesday - stands apart from current drugs that treat fibromyalgia pain. Savella is the first drug approved to treat multiple aspects of fibromyalgia: pain, physical function and overall well being, they said.

Fibromyalgia affects as many as 6 million Americans and is characterized by a complex set of symptoms, including joint and muscle pain, fatigue and depression.

Pfizer Inc.'s Lyrica, a drug for epilepsy, was the first treatment approved for fibromyalgia and had U.S. sales of $1.48 billion in 2007 and $1.065 billion for the first nine months of 2008. The antidepressant Cymbalta by Eli Lilly and Co., also is approved for the condition.

Those two drugs were based on "more limited approvals" that focused on fibromyalgia pain, while Savella is the only one that has been shown to improve fibromyalgia symptoms in three areas, Jay Kranzler, Cypress chairman and CEO, told BioWorld Today. He said he believes that Savella will be a first-line drug for treating fibromyalgia.

"Lyrica and Savella are very different drugs in terms of the patient experience," Kranzler said, drawing contrasts with the most prescribed fibromyalgia drug.

Savella was approved sooner than expected, on a first-cycle FDA review, but Cowen & Co. analyst Ian Sanderson said in a research note that he expected only "gradual uptake" amid tough competition from Lyrica and Cymbalta. He estimated that Savella sales would be $60 million in 2010, $130 million in 2011 and reach $350 million in 2015.

The approval of Savella was based on two U.S. pivotal Phase III trials involving more than 2,000 patients with fibromyalgia. A greater proportion of patients treated with Savella as compared with placebo treatment met the criteria for a treatment response, measured by concurrent improvements in pain, physical function and patient global assessment.

The most common adverse event with Savella was nausea. Other common adverse reactions reported in those clinical trials included constipation, palpitations, heart rate increased, dry mouth and hypertension. However, the majority of adverse reactions reported were mild, the companies said.

Savella has a more stringent clinical trial endpoint than currently approved fibromyalgia therapies, Jeffereies & Co. analyst Marko Kozul said in a research note. However, he said Savella's side-effect profile is "in line with competing therapies." Still, he said that Savella would likely be a highly competitive therapy in the fibromyalgia setting.

"Fibromyalgia is a complicated chronic pain condition, so it is important that physicians and patients have access to treatments that have been shown to help manage the symptoms that define the experience of fibromyalgia," Daniel Clauw, professor of anesthesiology and medicine at the University of Michigan, said in a company news release.

Savella contains milnacipran, a drug in the same family as a class of antidepressants known as serotonin and norepinephrine reuptake inhibitors. Savella works by blocking the reuptake of both serotonin and norepinephrine, two neurotransmitters thought to a play a central role in the symptoms of fibromyalgia.

The safety information for Savella warns about the risk of suicidal tendencies associated with antidepressants that are similar to Savella.

Shares in Cypress Bioscience (NASDAQ:CYPB) gained $2.40, or 33.3 percent, closing at $9.61 Thursday. Shares of Forest Laboratories (NYSE:FRX) gained $1.77 to close at $26.