EnteroMedics Inc., based in Roseville, Minnesota, said Monday that the Food and Drug Administration has approved a new clinical trial for its Maestro anti-obesity device that uses electricity to suppress hunger.
The news represents a major victory for EnteroMedics whose previous study ended in failure. Last October, initial results from the EMPOWER studies of more than 400 patients showed people who used the Maestro device lost just as much weight as patients implanted with the dummy device.
In a previous interview, CEO Mark Knudson said wires from the sham device connected to the nerve released low-intensity energy whenever the company performed a safety check on the device. As a result, the Maestro device delivered 10,000 times more electricity to the therapy group but did not perform any better than the control group’s dummy device.
Since January, the company has been negotiating with the FDA on a study through the agency’s Investigational Device Exemption program.
The new 12 month study, dubbed ReCharge, will enroll 234 morbidly obese people who will randomly be implanted with Maestro or a sham device. This time, the dummy device will have no wires connected to the nerve. Patients will also use an updated Maestro device in which the battery pack will be worn around the belt instead of an implant.
The company hopes patients with Maestro will lose 20 percent more weight than people implanted with the dummy device. The trial will begin the second half of 2011.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
