St. Jude Starting Trial On Brain Stimulation For Depression
Feb 7, 2008 08:00:00 (ET)
St. Jude Medical Inc. (STJ) has garnered Food and Drug Administration approval to launch a trial the company plans to use to pursue U.S. approval for a pacemaker-like device that uses electricity to treat severe depression.
The invasive treatment involves implanting wires in a part of the brain that can be overactive in patients with severe depression, and using electric stimulation from a connected device to calm that activity. There are limited data backing this approach, but St. Jude aims to collect enough evidence in the new randomized study to pave the way to regulatory support.
"Our intent is to receive a PMA as a result of this trial," said Rohan Hoare, vice president of research and development at St. Jude's ANS Division, referencing a type of FDA device approval.
The patients who could potentially benefit from this technology have long-term depression and have failed numerous treatment attempts with drugs or electroconvulsive therapy. About four million Americans are estimated to fit into this category, creating a broad potential market for medical device companies with effective systems.
A handful of device makers are exploring or have actively pursued the market, including device heavyweight Medtronic Inc. (MDT), which like St. Jude has deep brain stimulation technology. Northstar Neuroscience Inc. (NSTR) and Cyberonics Inc. (CYBX) are smaller device companies with an interest in depression treatment - the latter company has an FDA-approved nerve stimulation tool, but has been stymied by lack of insurance reimbursement coverage.
St. Jude, a St. Paul, Minn., company known for heart-rhythm devices such as pacemakers and defibrillators, has a growing business for devices used to treat certain neurological issues. The neuromodulation business produced $210 million in revenue in 2007, a 17% climb from the prior year, but still represented a small portion of St. Jude's overall $3.78 billion sales tally on the year.
The company got into the neuromodulation business by purchasing Advanced Neuromodulation Systems, or ANS, in 2005.
The FDA has granted what is known as an investigational device exemption that clears St. Jude to begin enrollment for the "Broaden" trial, which will start at three centers and then add centers later on, Hoare said.
Due to competition in the chase for a depression-treatment device, Hoare declined in an interview to say how many patients will be included in the St. Jude-funded trial, and didn't forecast timing for potential device approval. The need to enroll patients, track them for a year and then pursue regulatory approval suggests it could take a couple of years or so to bring a depression-treatment device to the market.
All patients in the randomized study will receive a device, but it won't be turned on for one-third of patients until after six months. According to researcher Andres Lozano, a neurosurgeon from the University of Toronto, patients won't be able to tell whether it's on or not. The trial will run for a year, with an option for longer-term study.
The specific approach St. Jude is taking is based on work by Lozano and neurologist Helen Mayberg, now with Emory University School of Medicine, Atlanta, that led them to try deep brain stimulation in a part of the brain called "Brodmann Area 25" that is thought to be linked to severe depression.
They tested the technology on six patients in a study earlier this decade - they used Medtronic deep brain stimulation technology in that study - and saw positive results.
"The idea is that this area of the brain is abnormal in patients with depression," Lozano said in an interview. "What we're essentially doing is applying a dimmer switch."
St. Jude said it holds intellectual property rights and has patents pending for the use of stimulation in this part of the brain, and has another depression study under way overseas that studies use of stimulation there for depression. Results from that trial, which has about 20 patients, will be unveiled at medical conferences this spring.
In comparison with other potential device treatments for depression, Lozano said stimulating the Brodmann Area 25 may differ because "it is a very direct approach." Further research will determine the effectiveness of this or other methods, he said.
St. Jude's nearby rival Medtronic, Minneapolis, has also talked about its interest in using deep brain stimulation to treat severely depressed people. The company issued a press release in April 2006 saying it planned to pursue a "major clinical trial" on the matter, and that it holds several patents related to treatment of psychiatric disorders including depression.
In that release, a Medtronic official said the company would be working with the FDA "in the coming months to complete a study design." A study has not launched yet, but Medtronic continues to support research on the matter and plans to initiate a clinical study this year, spokeswoman Cindy Resman said.
Cyberonics has approval to treat severe depression with its pacemaker-like device that hooks up to a major nerve. However, the company's efforts to open up a real market for the expensive technology were more or less blocked last year when the government denied Medicare reimbursement. That decision pushed Cyberonics into cost-cutting mode and redirected the company's focus to its main market for epilepsy treatment.
Northstar Neuroscience has yet another style of neuromodulation technology that stimulates the outer surface of the brain, or cortex. The company had been pursuing the market for stroke rehabilitation, but announced last month that its key stroke trial failed, sending shares into a tailspin and raising questions about what the small company will do next.
Northstar is now considering using its cash and technology to explore treatment of severe depression or tinnitus - the perception of ringing in the ears - and has said it plans to say more later this month about what market it will pursue.
-By Jon Kamp, Dow Jones Newswires; 312-750-4129; jon.kamp@dowjones.com
(END) Dow Jones Newswires
February 07, 2008 08:00 ET (13:00 GMT)
