Body Position and Limb Movement Modules Becomes FDA Approved
The US Food and Drug Administration recently approved the new body position and limb movement modules used with the Easy® Ambulatory 2 EEG system manufactured by Cadwell Laboratories, Kennewick, Wash. The Easy Ambulatory 2 EEG system can collect ambulatory EEG data for multiple days, allowing physicians to capture important events that normally occur in the home and work environment. The body position and limb movement modules are connected to the recorder via Cadwell’s patent-pending EasyNet™ communications technology.

d04a.JPG (13334 bytes)“These modules were designed specifically for the ambulatory patient and are about the size of a small wristwatch. The limb movement modules are worn on the wrists and ankles. A body position module is also worn by the patient and allows the clinician to see in full color animation the body position at any given time during the study,” says Bill Antilla, RPSGT, senior product manager.

Physicians can collect the virtual animation data along with ambulatory EEG data. After data collection, clinicians can play back the time synchronized animation and EEG data. “We see this as a valuable tool for neurologists and sleep physicians. Animating the patient in a remote environment allows the physician to see three-dimensional representations of patient body position and limb movements during seizures and cataplectic events. Patient animation also allows the clinician to collect movement data while protecting patient identity and privacy,” Antilla says.

Takeda Submits NDA to Market Insomnia Treatment
In September, the US Food and Drug Administration (FDA) received a new drug application (NDA) for an investigational insomnia drug with the first novel mechanism of action to be developed in 35 years in the area of sleep research, according to Takeda Global Research & Development Center, makers of the drug.
Called ramelteon (TAK-375), the drug specifically targets the MT1 and MT2 receptors in the brain, which are believed to be critical in the regulation of the body’s sleep-wake cycle. The MT1 receptor is thought to regulate sleepiness, while the MT2 receptor is believed to help the body shift easily between phases of day and night. Currently prescribed sleep agents and some investigational drugs work by targeting gamma-aminobutyric acid (GABA) receptors, which are located throughout the brain. In preclinical studies, ramelteon has shown no affinity for GABA or opiate receptors, the Lincolnshire, Ill-based company says.

The NDA submission is based on data collected from Takeda’s clinical research program, including recently completed phase 3 studies.

Clinical Trial To Evaluate Fibromyalgia Medication
Patient enrollment has begun in a clinical trial designed to evaluate Xyrem® (sodium oxybate) oral solution in the treatment of fibromyalgia. A chronic condition characterized by widespread muscle pain and stiffness, fibromyalgia is estimated to affect more than 4 million Americans—women three times more often than men. Other symptoms include persistent fatigue, headaches, cognitive or memory impairment, morning stiffness, and nonrestorative sleep.
Following US Food and Drug Administration protocol, 150 patients will complete a 3-month trial with an 8-week active treatment period to assess the impact of Xyrem on the symptoms of fibromyalgia. The makers of Xyrem, Minneapolis-based Orphan Medical, expect initial data from the trial to be available in mid 2005.

“This trial is an important step in evaluating the potential of Xyrem in the treatment of fibromyalgia, and we will work to complete this trial quickly, and if the outcome is positive, we will work with the FDA to aggressively move forward on a program for development,” says John Bullion, Orphan Medical CEO.

Xyrem is currently FDA approved for cataplexy associated with narcolepsy and is being assessed as a treatment for excessive daytime sleepiness in narcolepsy. Fibromyalgia represents a market opportunity in excess of a billion dollars per year.

Sleep Giants Unveil
Two leaders in sleep disorder therapies have joined together to launch an educational consumer resource Web site. The site,, unveiled in August, was created by Murrysville, Pa-based Respironics and Poway, Calif-based ResMed. Designed as an objective resource for OSA sufferers, it promotes the companies’ recently initiated sleep apnea public awareness campaign called “Sleep Well, Be Healthy.” Visitors to the site can explore the causes of OSA, its symptoms, diagnosis, and treatment, as well as download and print a self-assessment quiz and access the latest published OSA studies and other links. The Web site also includes a sleep dictionary and the results of a nationwide survey on the public’s perception of sleep and its role in health.

FDA OKs Implantable OSA Treatment
In September, the US Food and Drug Administration (FDA) awarded 510(k) clearance to St Paul, Minn-based Restore Medical to market the Pillar Procedure as an implantable treatment for mild to moderate OSA.

With the Pillar Procedure, three inserts are placed in the patient’s soft palate, causing the palate to stiffen. The stiffening helps to prevent or lessen blockages of the airway. Pillar inserts are less than one inch long and made from a woven, soft polyester material. Designed as a first-line treatment option, the procedure is conducted in a single physician’s office visit using local anesthesia, and it is reversible.

Most patients report that the procedure, previously approved only to treat snoring, is virtually painless and that they are able to resume normal activities and diet the same day, Restore Medical reports. In nearly 80% of patients in an OSA clinical study, sleep apnea was reduced, according to the company.