FDA Approves Symbyax For Treatment-Resistant Depression

Symbyax, an Eli Lilly drug which combines the top-selling antipsychotic drug Zyprexa and the leading antidepressant Prozac, has been approved by the Food and Drug Administration for patients with treatment-resistant depression.

People who suffer from depression and have failed to respond to treatment with at least two regular antidepressants are said to have treatment-resistant depression. The FDA has previously delayed approvals for Symbyax and required Lilly to gather more data about the drug.

Symbyax is billed by its maker as being the first drug for treatment-resistant depression, but another drug – Abilify, the blockbuster pill made by Bristol-Myers Squibb – already is marketed as “add-on” therapy for depression. However, unlike Abilify, which must be taken along with an antidepressant, Symbyax combines an antipsychotic with an antidepressant in a single pill.

Antidepressants Among Most Commonly Prescribed Drugs

Prozac, Zyprexa, and other brands of potent antipsychotics belonging to the class of drugs called selective serotonin reuptake inhibitor (SSRI) have been linked to severe side effects in people. In 2006, a study published in the New England Journal of Medicine found that persistent pulmonary hypertension (PPH) was six times more common in babies whose mothers had taken an SSRI after their 20th week of pregnancy.

Zyprexa is widely prescribed for unapproved treatment of disorders such as anxiety disorder, panic disorder, post traumatic stress disorder, and psychological disorders in children and adolescents. It has been blamed for causing an increase in rates of diabetes, hyperglycemia, pancreatitis and other blood sugar disorders.

SSRI Use Increasing

The use of SSRIs has soared in recent years among the nearly 20 million Americans who have some type of depressive disorder. The drugs have also been prone to abuse and misuse, including to quiet unruly senior citizens with dementia and children with attention-deficit hyperactivity disorder (ADHD) and other behavioral problems.

Abilify, a competitor of Symbyax, is among one of the fastest-growing drugs in terms of sales, reaching $2.1 billion in 2008.

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