VelaPharm Awarded Patents For Very Low-Dosage (VLD) Cyclobenzaprine For Treatment Of Sleep Disorders And Generalized Anxiety Disorder (GAD)

Market Wire, July, 2002

The United States Patent Office has issued two patents to Vela Pharmaceuticals Inc. (www.velapharm.com), a privately held pharmaceutical company specializing in the development of medicines for the central nervous system, for very low-dosage cyclobenzaprine (less than 5 mg per day). The patents cover the treatment of sleep disorders and generalized anxiety disorder (GAD).

Cyclobenzaprine, approved by the FDA for more than 20 years for use as a muscle relaxant at higher doses, is being studied by VelaPharm at very low doses for improvement of the quality of sleep. Preliminary results are encouraging. Most drugs used to treat sleep disorders focus only on decreasing sleep latency--that is, the amount of time it takes to fall asleep--but do not answer the need for maintaining a high quality of sleep throughout the night, a need particularly prevalent among the elderly.

In addition to the two patent approvals, VelaPharm has recently completed a Phase II study using VLD cyclobenzaprine (results pending) and has filed for patent protection for the treatment of fibromyalgia (at present, no drugs have been approved by the FDA for the treatment of fibromyalgia). Preliminary results are encouraging.

"Cyclobenzaprine has been widely prescribed for the treatment of muscle spasm since the 1970s," says Steven M. Leventer, PhD, Vice President of VelaPharm's Clinical Research and Development department. "As we continue the development of this drug via expanded clinical trials, we are truly excited by the possibility that VLD cyclobenzaprine may offer new choices to the millions of Americans who suffer from these illnesses."

Patent no. US 6,395,788 B1 was issued on May 28, 2002 for the prevention and treatment of sleep disturbances and illnesses manifested with sleep dysfunction, including chronic fatigue syndrome, sleep disorders, psychogenic pain disorders, and chronic pain syndromes or symptoms thereof.

Patent no. US 6,358,944 B1 was issued on March 19, 2002 for the prevention and treatment of generalized anxiety disorder (GAD).

About VelaPharm

Vela Pharmaceuticals Inc., a privately held company, specializes in the development of medicines for central nervous system (CNS) disorders. VelaPharm leverages the value of existing molecules by developing new therapeutic uses for marketed compounds, expanding access of known agents proven safe and effective but currently available only in limited geographic regions, reformulating existing products, including isomeric purification, for improved efficacy, compliance, and/or safety, and in-licensing promising, late-stage candidates de-prioritized by other companies.

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