You can lose weight through plenty of methods. Dieting. Exercising. Taking weight-loss drugs. Undergoing gastric bypass surgery. The newest way, though, just might be the coolest and most revolutionary way of all.
Tricking the brain
On Wednesday, the FDA approved a device that tricks your brain into thinking it isn't hungry. The Maestro System developed by EnteroMedics (NASDAQ:ETRM) sends electrical pulses to the abdominal vagus nerve. This blocks communication between the nerve and the brain, preventing the brain from realizing that you are hungry.
A clinical trial found that more than half of the patients who used the device lost at least 20% of their excess weight. Over 38% of patients using the device shed 25% or more of their excess weight. Those results helped convince the FDA to allow EnteroMedics to bring its Maestro System to market in the U.S.
Not everyone who wants to lose weight will be able to use the device, though. The FDA's approval limits the treatment to only adults aged 18 or over who weren't able to lose weight through another weight loss program. You can't be just a little overweight, either. Only severely obese individuals with a body mass index of 35 to 45 and with at least one other obesity-related disease such as diabetes will be able to use the Maestro System.
Will obese Americans line up to get this device that fools their brains? That remains to be seen. Some physicians could be hesitant to prescribe the treatment because the clinical trial didn't meet its primary endpoint of 10% more weight reduction compared to the control group of patients who didn't use the device. Patients using the Maestro System lost 8.5% more excess weight than the control group patients did.
This isn't a device you can just strap on and fire up, either. The Maestro must be implanted. The good news it that this procedure can typically be performed in an outpatient setting.
Also, some patients could experience adverse effects. During the clinical trial, 3.7% of patients had severe adverse events, including nausea, vomiting, pain at the implant site, and surgical complications. Other non-serious adverse events included pain, heartburn, problems swallowing, belching, mild nausea and chest pain.
Shaking things up
Even with some drawbacks, the Maestro System could shake things up in the obesity treatment market. Three weight-loss drugs have been approved by the FDA in the past couple of years: Arena Pharmaceuticals' (NASDAQ:ARNA) Belviq, Orexigen Therapeutics' (NASDAQ:OREX) Contrave, and VIVUS' (NASDAQ:VVUS) Qsymia. Two of the three have proven to be disappointments compared to initial expectations.
Arena first won U.S. approval for Belviq back in June 2012. VIVUS quickly followed by gaining FDA approval for Qsymia the next month. However, Arena was forced to wait on the U.S. Drug Enforcement Administration for several months before bringing Belviq to market. Neither drug has achieved the level of sales that investors had desired.
Orexigen is newer to the party, winning FDA approval for Contrave last September. Some observers think Contrave could fare better than its rivals because of a large cardiovascular outcomes study and the marketing prowess of its sales partner, Takeda.
Now, all three drugs face a non-pharmaceutical competitor. Based on the clinical study results, the brain-tricking medical device could have the upper hand in achieving significant weight loss. But can Maestro leave Belviq, Contrave, and Qsymia in the dust? Probably not.
For one thing, the FDA was more restrictive in its approval for the Maestro than it was for any of the drugs. Physicians can prescribe the weight-loss drugs for patients with less severe obesity than permitted for the device.
There's also the convenience factor. Some patients might prefer taking a pill over having an implant that requires a surgical procedure.
Most important, though, is cost. The price tag for the Maestro Systems is over $15,000. Some insurers could balk at paying up, although the case could be made that the reduced healthcare costs associated with obese patients losing weight could easily make that price a good bargain.
No matter what happens, EnteroMedics has certainly made things more interesting in the weight-loss industry. And many patients will now have a totally different option for helping them shed pounds than ever before.