New Antidepressant Approved
Revamped Version of Celexa Has Few Side Effects
Aug. 15, 2002 -- The FDA today approved a new form of the popular antidepressant drug Celexa that promises to treat depression with fewer side effects. The drug, to be sold as Lexapro, was created using a relatively new approach that removed inactive ingredients in Celexa -- yielding a safer and more potent form of the medication.
Celexa and Lexapro are both part of the new generation of prescription antidepressant drugs known as SSRIs (selective serotonin reuptake inhibitors), which also includes Prozac, Zoloft, and Paxil. The medications work by increasing the activity of a certain brain chemical involved in depression called serotonin.
Nearly 19 million Americans suffer from some type of depression. Researchers say one in four women and one in 10 men will be diagnosed with depression within their lifetime.
SSRIs have rapidly become the first choice of many doctors for the treatment of depression, but the drugs can take up to six weeks to provide relief and come with some side effects. These side effects -- including nausea, anxiety, problems sleeping, loss of sexual desire, and headaches or dizziness -- are not life-threatening, but can be problematic for many SSRI users.
But because Lexapro contains a more concentrated and purified form of the active ingredient in Celexa, it can be given at much lower doses, which means it causes fewer side effects. Clinical trials of Lexapro in people with moderate to severe depression found a dose of 10 mg per day of Lexapro was as effective as a daily 40 mg dose of Celexa.
Andrew Farah, MD, medical director of behavioral services at High Point Regional Health System in North Carolina, says intolerable side effects are the main reason that only about 40% of those who seek treatment for depression complete the recommended therapy.
"The real advance is that this drug seems to be devoid of virtually all side effects," says Farah, who is also a clinical professor at Wake Forest University. "I think most people who have tried antidepressants in the past and didn't like them because of the side effects will be very pleased with this one."
The most commonly reported side effect of Lexapro was nausea, and it occurred in 15% of the patients who received the drug, compared with 7% among those who took a placebo. Other side effects occurred at a rate similar to the placebo group and included insomnia, ejaculation disorder, sleepwalking, and fatigue.
"I think it's a really important step because we've been using these [SSRI] drugs since Prozac came out in 1986, and this is the first real, elegant refinement where you see such a nice cleanliness and such a nice tolerability," says Farah.
In addition, clinical trials suggest that many patients' depressive symptoms may begin to improve within a week or two after they began taking Lexapro. Studies on other SSRIs have had similar findings.
Farah says similar modifications have been attempted with other types of SSRIs but this is the first version that has been so successful in treating depression without producing unwanted side effects.
The manufacturer of Lexapro, Forest Laboratories, Inc., says it expects the drug to be available in pharmacies by Sept. 5. Lexapro is expected to cost about 8% less than Celexa, which currently costs about $60 for a month's supply of the 20 mg tablets.