Vela Pharmaceuticals Announces Completion Of Phase II Trial Of Very-Low Dosage Cyclobenzaprine In Patients With Fibromyalgia

Market Wire, 20050229

Vela Pharmaceuticals Inc. (VelaPharm.com), a privately held pharmaceutical company specializing in the "rediscovery" and development of medicines for the central nervous system (CNS), announced Friday at the ACR/ARHP (American College of Rheumatology/Association of Rheumatology Health Professionals) Annual Scientific Meeting in New Orleans, the successful completion of its Phase II study of very-low dosage cyclobenzaprine.

The study included 36 subjects suffering from fibromyalgia syndrome and poor sleep. Fibromyalgia syndrome is a common and debilitating rheumatological condition for which there are currently no FDA-approved drugs. In this study, subjects received either very-low dosage cyclobenzaprine (1-4 mg, taken as a single dose before bedtime), or placebo for eight weeks. Results indicate that, compared to placebo, very-low dosage cyclobenzaprine dramatically reduced musculoskeletal pain and fatigue, and improved sleep. No serious adverse events were reported throughout the study. The Principal Investigator was Dr. Harvey Moldofsky, Toronto, Canada.

"Cyclobenzaprine, taken in much higher dosages, usually several times a day, has been widely used for the treatment of muscle spasm," said Kevin L. Keim, MSc, PhD, President and CEO of VelaPharm. "While further work remains to be done, our data suggest that very low-dosage cyclobenzaprine, taken once daily, may help patients suffering from the pain, fatigue, and disrupted sleep often associated with fibromyalgia."

About VelaPharm

Vela Pharmaceuticals (velapharm.com) is a privately held company specializing in the "rediscovery" and development of central nervous system (CNS) medicines. VelaPharm leverages its clinical trial expertise to increase the value of molecules already proven safe in humans. Investors include JP Morgan Partners, New Enterprise Associates, and Venrock.

Vela Pharmaceuticals Inc. 3131 Princeton Pike, Building 4, Suite 216 Lawrenceville, NJ 08648