MALVERN, Pa., April 5 /PRNewswire/ -- Results presented today confirm a previously published study in demonstrating that MYOBLOC (Botulinum Toxin Type B) Injectable Solution and BOTOX(R) (Botulinum Toxin Type A) Purified Neurotoxin Complex have comparable clinical profiles. The results are particularly important in that the study enrolled only toxin-naive (never previously treated with toxin) patients, whereas earlier studies with MYOBLOC enrolled patients who had been previously treated with another toxin product.
The duration of effect was 13.6 weeks from injection for MYOBLOC, while the duration of effect for BOTOX(R) was 13.1 weeks from injection. Patient efficacy outcomes were not different based on a validated rating instrument known as TWSTRS. The previously published study also utilized the same validated instrument. The study achieved the statistical significance level for the primary efficacy endpoint. Both agents were similarly well-tolerated.
These results were presented at the April 2006 American Academy of Neurology (AAN) 58th Annual Meeting, attended by 10,000 neuroscientists and neurologists seeking the latest developments in cutting-edge scientific research.
Neurologist Dr. Eric Pappert, who is the Medical Director for Solstice Neurosciences, Inc., and Assistant Professor of Neurology, and Director of the Parkinson’s Disease and Movement Disorders Program at the University of Texas Health Science Center, San Antonio, summarized, “This study is important because it reassures physicians that MYOBLOC can be considered as initial therapy for both toxin-naive patients as well as patients previously treated with other botulinum toxin products.”
This second head-to-head study of MYOBLOC vs. BOTOX(R) validates the usefulness of MYOBLOC as a treatment for Cervical Dystonia in toxin-naive individuals. MYOBLOC already has a well-established use in those patients who have become resistant to botulinum toxin type A as evidenced in numerous clinical trials. MYOBLOC also offers an advantage over BOTOX(R) because it is available in a ready-to-use solution.
About the Randomized, Double-Blind Trial Design
One hundred-eleven (111) toxin-naive subjects participating in centers across nine European countries were randomized into the ANO72-402 study. Eligible subjects had cervical dystonia (CD) of at least six months duration that involved two or more predefined muscles, and a baseline Toronto Western Spasmodic Torticollis Rating Scales (known as TWSTRS, a validated tool to assess the severity of CD) score of at least 20. No subject had prior exposure to any botulinum toxin product. Subjects were randomly assigned to receive 2 cc containing either 150 units of BOTOX(R) or 10,000 units of MYOBLOC and evaluated in a blinded fashion at baseline, four, eight and 12 weeks post initial injection, and every four weeks thereafter until return to baseline.
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.
Solstice Neurosciences, Inc.
CONTACT: Diane Murray, Director - Business Operations and Communications,Solstice Neurosciences, Toll-Free +1-866-220-5042, or Direct+1-267-620-8056, Email: diane.murray@solsticeneuro.com
Web site: http://www.solsticeneuro.com/
