New Botulinum Toxin Therapy

by | August 16, 2010 @ 02:00PM

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Elan Pharmaceuticals announced that it is investigating the potential use of MYOBLOCÔ (Botulinum Toxin Type B) Injectable Solution in a variety of spasticity, pain, and dermatologic applications.

The clinical benefits of botulinum toxin therapy in the treatment of various clinical disorders characterized by muscle hyperactivity, such as spasticity, was established more than 10 years ago by the National Institutes of Health. The potential market for the applications under investigation by Elan is considerable.

"The use of botulinum toxin has become an enormously popular form of therapy for a variety of applications," said Leslie Baumann, MD, University of Miami Cosmetic Center, Cedars Medical Center. "MYOBLOC is an exciting new treatment option that doesn't need to be reconstituted nor kept frozen, an important consideration in administering botulinum toxin therapy."

MYOBLOC for the Treatment of Cervical Dystonia

MYOBLOC was recently approved for the treatment of cervical dystonia. It is the first new botulinum toxin therapy in a decade, and the only botulinum toxin formulated as a ready-to-use solution.

Type B is an antigenically distinct serotype from botulinum toxin type A (Botox) and was FDA approved last December for the symptomatic treatment of patients with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with the disorder. MYOBLOC works by preventing the release of acetylcholine from the nerve ending to the overactive muscle. Involuntarily muscle contractions can cause pain, tightness, and spasms.

"Clinical studies have demonstrated that MYOBLOC is a highly potent and long lasting botulinum toxin therapy and we are excited about evaluating type B's safety and efficacy in a variety of conditions," said Christopher O'Brien, Vice President, Medical Affairs, Elan. "Additionally, because of the advanced manufacturing technique employed in producing the drug, the result is a toxin that is consistent, pure, and stable."

MYOBLOC is available in three convenient vial configurations of 2,500 units, 5,000 units and 10,000 units, all at the same concentration providing maximum flexibility for dosing.

MYOBLOC is generally safe and well tolerated. The most frequently reported adverse events associated with MYOBLOC treatment were dry mouth, dysphagia (difficulty swallowing), dyspepsia (upset stomach), and injection site pain. These side effects are generally mild to moderate, temporary, clear up on their own, and more common with higher doses. If patients experience any side effects during treatment with MYOBLOC, they should contact their physician.

Caution should be exercised when administering MYOBLOC to individuals with motor neuron diseases (e.g., amyotrophic lateral sclerosis) or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome). Patients with neuromuscular disorders may be at increased risk of clinically significant systemic effects including severe dysphagia and respiratory compromise from typical doses of MYOBLOC.

Elan Pharmaceuticals is a division of Elan Corporation, plc. Elan is a leading worldwide fully integrated pharmaceutical company headquartered in Ireland, with its principal research, development, manufacturing and marketing facilities located in Ireland, the United States and Israel. Elan is focused on the discovery, development and marketing of therapeutic products and services in neurology, pain management, oncology, infectious disease and dermatology and on the development and commercialization of products using its extensive range of proprietary drug delivery technologies. Elan shares trade on the New York, London and Dublin Stock Exchanges.

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