Forest Laboratories Inc and Cypress Bioscience Inc, the developers of the fibromyalgia drug Savella, announced Wednesday that the Food and Drug Administration has cleared the drug.

 

Savella is generically called milnacipran.

 

Fibromyalgia is characterized by widespread pain with no clear cause, fatigue, sleep problems and depressed mood. The underlying cause or causes of the condition still remain a mystery. The most common sites of pain include the neck, back, shoulders, pelvic girdle, and hands, but any body part can be affected. Because of its debilitating nature, fibromyalgia has a serious impact on patients' families, friends, and employers, as well as society at large.

 

The condition affects up to 12 million people or 4 percent of the US population, nearly 11 million of them women. Since it has no cure, doctors usually prescribe exercise and relaxation techniques, painkillers and sometimes low-dose antidepressant to treat the symptoms.

 

The FDA approved the Savella following two US pivotal Phase III clinical trials involving more than 2,000 patients with the condition, the companies said. Now, they hope the drug will be available in pharmacies by March 2009.

 

The drug will face fierce competition from other already-on-the-market drugs such as Elli Lilly’s Cymbalta and Pfizer’s Lyrica, which are widely prescribed for patients suffering from fibromyalgia. Cymbalta is top-selling antidepressant for Lilly, which fetched sales of $1.98 billion in the first nine months of 2008, up 34 percent from 2007.