Cerephex To File Fibromyalgia Treatment 510(k) Within A Year

Article preview from "The Gray Sheet"- May 31, 2010

Cerephex will file a 510(k) application within a year to treat fibromyalgia with its NeuroPoint non-invasive cortical stimulation device, the firm says.

Cerephex To File Fibromyalgia Treatment 510(k) Within A Year

Article preview from "The Gray Sheet"- May 31, 2010

Cerephex will file a 510(k) application within a year to treat fibromyalgia with its NeuroPoint non-invasive cortical stimulation device, the firm says.

If cleared, the device would be the first non-drug treatment available specifically for fibromyalgia pain, according to the company, though firms including Medtronic, Boston Scientific and St. Jude Medical currently market implantable spinal stimulation devices for various types of chronic pain.

Fibromyalgia, which is characterized by chronic, widespread pain that is typically accompanied by fatigue and sleep disturbances, impacts about 10 million U.S. patients and about 2%-4% of the global population, according to the American Fibromyalgia Association.

The company plans to meet with FDA in July to get feedback on data from its 85-patient U.S. trial, conducted from 2006 to 2008 at three hospitals in Michigan. The Detroit firm notes that it submitted the data to FDA earlier this month in anticipation of the meeting.

The device delivers imperceptible cortical stimulation through three electrodes that are attached to the somatosensory cortex at the top of the scalp using a patient-specific disposable cap.

The cap and accompanying electrodes are connected to a cart-mounted system that sends out low amplitude, high frequency carrier waves that deliver a low-frequency electrical signal to the brain, the company explains. The electrical signal acts on neurons that have become hyperplastic, or overactive, in order to achieve its therapeutic effect.

Individual treatments last three-and-a-half minutes and are intended to be delivered by lab technicians under physician supervision while the patient sits in a chair. Repeat applications modulate local cortical activity for lasting therapeutic results, the company claims.

The firm's randomized, double-blind, placebo-controlled study applied 22 treatments per patient over the course of 11 weeks.

Data unveiled May 19 at the Neurotech Investing and Partnering Conference in Boston by CEO Ronald Burch included an average of 17 months of follow-up on 18 patients, though some existing follow-up extends to three years, the company notes.

Data collected one week after final treatment sessions showed that 59% of NeuroPoint patients had at least a 50% clinical improvement, versus 2.6% of placebo patients.

At an average of 17 months post-treatment, 83% of treated patients had pain that was "better" or "much better," while 5.6% reported "worse" pain. And over 70% said the treatments helped reduce their need for pain medication to "less" or "much less."

Patients also demonstrated no significant side effects or long-term unintended consequences, according to the company. The clinical results "were pretty astonishing," Burch said in an interview with "The Gray Sheet."

The exec estimates that NeuroPoint therapy would cost about $2,500 for 11 weeks of treatment. While the firm has begun discussions with CMS over Medicare reimbursement, Burch said he expects that private insurers would provide reimbursement from the beginning.

The NeuroPoint system itself would cost $25,000, but physicians would also have the option to rent the devices, according to the company.

While competing drug therapies include Lyrica (Pfizer), Cymbalta (Lilly) and Savella (Forest Labs/Cypress Bioscience), side effects may discourage use by some patients, and 19% of patients refuse drugs, Cerephex says. The firm notes that just a 10% market penetration rate could represent a $1.5 billion opportunity for Cerephex.

U.S. Market Launch Planned By 2012

Burch expects NeuroPoint to debut in the U.S. within two years.

The three-person start-up has begun efforts to raise $10 million in "Series A" funding to help it complete the manufacturing process, hire a sales force and launch the product commercially. The 18-month old firm's study was supported by grants from Michigan State University.

- Mark Hollmer


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