Savella, a drug for treating fibromyalgia has been approved by the FDA. The drug is a serotonin and norepinephrine reuptake inhibitor. The drug is being manufactured by Forest Laboratories Inc (FRX. N) and Cypress Bioscience Inc. (CYPB. O). Savella would be available by March 2009.

Two US pivotal Phase III trials were conducted to establish the credentials of the drug. Over 2,000 patients with fibromyalgia were involved in the trials.

The drug can only be prescribed for adults. It will bear the same "black box" warning as other antidepressants - increased risk of suicidal thinking and behavior in children, adolescents and young adults.

The FDA is also insisting on post marketing studies of the pregnancy and fetal outcomes in women who take Savella during pregnancy. It would also require a clinical trial of Savella's effects on babies who get exposed to the drug from breastfeeding.

The drug does not have any serious side effects. Nausea is the most common effect found during the clinical trials. Some other reactions of Savella are constipation, hot flushes, sweating, vomiting, palpitations, increased heart rate, dry mouth, and hypertension (high blood pressure).