The Food and Drug Administration has finally given the approval that will allow
to sell its electronic vagus nerve stimulation therapy system as a treatment for depression.
The device is now indicated for chronic or recurrent depression when four previous treatments have failed. The system is the first implantable device used to treat depression, according to the Houston-based company.
Previously approved to treat epilepsy, the device works like a pacemaker, emitting low-level electric pulses. In this case, the shock is delivered to the vagus nerve.
About 4 million people have chronic or recurrent treatment-resistant depression that's failed to respond to multiple treatments, including drugs, talk therapy and in some cases electroconvulsive therapy, according to Cyberonics.
"Today for the first time, Americans with treatment-resistant depression have an FDA-approved, informatively labeled, long-term treatment option for their lifelong and life-threatening illness," said Robert Cummins, Cyberonics' chairman and CEO.
Shares of Cyberonics were recently down 67 cents, or 1.5%, to $44.31 after trading as high as $46.88 earlier in the session.
Drugs used for epilepsy, such as
Depakote, have been used to treat depression for years. The two conditions are often present at the same time.
Investors had been awaiting an FDA decision for several weeks. The final approval comes after a drawn-out process to get the VNS therapy approved for depression.
Last June, an FDA advisory panel voted to recommend the therapy for depression after other treatments didn't work. Then in August, the FDA overruled the advisory panel. But in February the agency reversed course and gave the go-ahead, providing Cyberonics met certain conditions.
The Cyberonics device is surgically implanted into a patient and has been available in the U.S. since 1997 for treating epilepsy. The VNS therapy system was approved for treatment-resistant depression in Europe and Canada in 2001.