Symbyax is the first drug approved by the FDA for depression that has not successfully been treated in at least two previous attempts. The drug was approved in 2003 for bipolar depression, a condition characterized by often debilitating mood swings that range from manic episodes (in which the patients is euphoric and irritated) to episodes of deep depression (in which the patients is extremely sad and has difficulties in functioning).

 

According to the National Institute of Mental Health, about 21 million people in the US, slightly fewer than 21 percent of the population, suffer from depressive illnesses each year.

 

“Living with major depressive disorder is difficult and distressing for anyone, but even so for patients whose symptoms continue despite treatment. Now, after two failed attempts with other antidepressants, doctors and patients have a new treatment option,” Lilly Medical Director Dr. Sara Corya said in a statement.

 

The company had to wait two years for the FDA’s approval because the regulators wanted the company to add stronger warnings on the label of the drug, including risk of weight gain, hyperglycemia, which can lead to diabetes, and hyperlipidemia (elevated lipids in the bloodstream including cholesterol).

 

Te FDA also said doctors could prescribe Zyprexa and Prozac, in separate pills, to treat bipolar depression and treatment-resistant depression.