MALVERN, Pa., April 10 /PRNewswire/ -- Results presented at a major medical conference late last week offered a unique look at the long-term tolerability and effects from repeated administration of Myobloc(R) (Botulinum Toxin Type B) Injectable Solution, marketed by Solstice Neurosciences.
"This is a different kind of study than has been completed to date on any neurotoxin treatment," said Dr. Mark Lew from the University of Southern California who led the trial and presented the data during the scientific meeting of the American Academy of Neurology (AAN) in San Diego.
This prospective observational study is the first looking at long-term efficacy and tolerability of a botulinum toxin in cervical dystonia (CD). Because MYOBLOC has already demonstrated efficacy and safety in previous single-dose trials, this study was focused on repeated dosing of MYOBLOC in CD patients for up to four years. Dr. Lew noted that no other currently marketed botulinum toxin therapy has reported on repeat treatment sessions for as long and with as many patients.
Results were presented by Dr. Lew and co-author Dr. Stewart Factor from the Emory University School of Medicine, Atlanta. At the poster presentation, Dr. Lew stated that even with repeat dosing of up to 14 injections, the safety profile of MYOBLOC remained consistent with its FDA-approved labeling.
In addition, MYOBLOC remained effective in CD with repeated dosing over the course of the study. The patient response was measured using the standard TWSTRS scale, a patient pain visual analogue scale, and other outcome metrics.
About the North American Multi-Center, Open-Label Extension Trial Design
Of the 437 CD patients enrolled, 235 completed this North American multi- center, open-label extension study of repeated doses of MYOBLOC. On the first injection, subjects were administered 5000U (toxin-naive subjects), 10,000U or highest MYOBLOC dose previously received. Re-injection occurred not sooner than 12 weeks from previous injection. Efficacy was evaluated by TWSTRS score, patient pain and global visual analogue scales (VAS) and were performed at each baseline (injection) and four weeks post-treatment and at four-week intervals.
About Cervical Dystonia
Cervical Dystonia (CD), also known as spasmodic torticollis, is a condition that primarily affects the muscles of the head and neck (the cervical area of the spine). Cervical dystonia is the most common dystonia requiring referral to movement disorder clinics. The neck muscles contract involuntarily causing abnormal movements and positions of both the head and neck. Muscle spasms in the neck often cause great pain, contributing significantly to the disability caused by the disorder. While the exact cause of CD is unknown, scientists believe the problem originates in the basal ganglia area of the brain that is instrumental in movement. Dystonia has an estimated prevalence of over 300,000 cases in North America. However, it is believed, that as few as 5% of these cases have been correctly diagnosed. Treatment is aimed at relaxing contracted muscles and reducing pain. In general, there are three main approaches to the treatment of CD: oral medications, surgery, and toxin therapy.
About Solstice Neurosciences, Inc.:
Founded in 2004, Solstice Neurosciences, Inc. is a biopharmaceutical company focused on the development, manufacturing, sales and marketing of specialty products. Solstice's first product, Myobloc(R) (Botulinum Toxin Type B) Injectable Solution 5,000U/mL, represents the only botulinum toxin type B currently available to physicians and patients worldwide. MYOBLOC is sold in the United States and approved in Canada. It is also sold and distributed in Europe as NeuroBloc(R). MYOBLOC is indicated for the treatment of patients with cervical dystonia (CD) to reduce the severity of abnormal head position and pain associated with CD. For more information about Solstice Neurosciences, Inc., visit http://www.solsticeneuro.com.
MYOBLOC is a registered trademark of Solstice Neurosciences, Inc.
Solstice Neurosciences, Inc.CONTACT: Diane Murray, Director-Business Operations & Communications,Solstice Neurosciences, Inc., +1-866-220-5042, or Direct, +1-267-620-8056,or diane.murray@solsticeneuro.com
Web site: http://www.solsticeneuro.com//
