MALVERN, Pa., June 15, 2007 /PRNewswire/ -- Solstice Neurosciences, Inc. today reported important results from a multicenter, forced dose escalation study of Botulinum Toxin Type B Injectable Solution (Myobloc(R)) recently presented at the 11th International Congress of The Movement Disorders Society in Istanbul, Turkey.
This was the first multicenter study to confirm patient safety and efficacy of escalating treatment doses of 10,000 Units, 12,500 Units, and 15,000 Units of Botulinum Toxin Type B in patients with cervical dystonia (CD).
The study results were presented by Eric J. Pappert, MD, who is assistant professor of neurology and director of the Parkinson's Disease and Movement Disorders Program at the University of Texas Health Science Center in San Antonio, Texas. Dr. Pappert also serves as Vice President, Medical & Scientific Affairs of Solstice Neurosciences.
"The recommended initial dose of Type B Toxin for patients with a prior history of tolerating botulinum toxin injections is 2,500 to 5,000 Units, with subsequent dosing to be optimized according to individual patient response. Pivotal clinical trials have used doses of 5,000 and 10,000 Units," said Dr. Pappert. "So, these data provide important insights for understanding how patients respond to higher doses. The results will also help guide the design of future studies."
Highlights from the open-label study included the following: -- 145 Subjects (95% Caucasian, 65% Female, Mean Age=53.1 years) -- Previous experience with neurotoxins -- Resistant to Type A (n=32; 22%) -- Responsive to Type A (n=113; 78%) -- Treatment: 3 escalating doses (10,000 Units, 12,500 Units, 15,000 Units) -- Measurement intervals: baseline, 2 weeks, every 4 weeks -- Effectiveness measurements: -- Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score (Torticollis Severity, Disability, Pain) -- Visual Analog Assessment (Patient Global, Investigator Global, Patient Pain)
Dr. Pappert reported, "In our study population, which we believe to be representative of people with CD in the United States, we found that escalating doses of Botulinum Toxin Type B were well-tolerated and efficacious. Using TWSTRS and the Visual Analog Assessments, we often saw improvement by the second week. Moreover, no treatment-related, serious adverse events were reported in any of the 145 subjects."
Shawn P. O'Brien, President and CEO of Solstice Neurosciences, commented, "The results reported by Dr. Pappert add to the ever-growing body of evidence that MYOBLOC can safely and effectively be used in a variety of CD patients for the pain and abnormal head position associated with this devastating and disabling condition."
About The Movement Disorder Society
Founded in 1985, The Movement Disorder Society (MDS) is a not-for-profit, international professional society of clinicians, scientists, and other healthcare professionals, who are interested in Parkinson's disease, related neurodegenerative and neurodevelopmental disorders, hyperkinetic movement disorders, and abnormalities in muscle tone and motor control. In 1992, the Society merged with the International Medical Society for Motor Disturbances. Its first International Congress was held in 1990.
Myobloc(R) (Botulinum Toxin Type B) Injectable Solution was the first FDA-approved neurotoxin indicated for the neck pain and abnormal head position associated with cervical dystonia.
Before administering MYOBLOC, physicians should consult the full Prescribing Information. The most frequently reported adverse events with MYOBLOC are dry mouth, dysphagia, dyspepsia, and injection site pain. These adverse events are generally mild to moderate, transient, self-resolving, and more common with higher doses. MYOBLOC is supplied as a ready-to-use, injectable solution in three single-dose vial sizes of 0.5 mL (2500 U), 1.0 mL (5000 U), and 2.0 mL (10,000U).
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, 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 distributed and sold in the EU as NeuroBloc. 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 www.solsticeneuro.com
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. 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. In general, there are three main approaches to the treatment of CD: oral medications, toxin therapy and surgery.
Myobloc(R) and NeuroBloc(R) are registered trademarks of Solstice Neurosciences, Inc.
CONTACT: Diane Murray, Director-Business Operations & Communications ofSolstice Neurosciences, Inc., Toll Free, +1-866-220-5042, Direct,+1-610-864-1691, firstname.lastname@example.org
Web site: http://www.solsticeneuro.com//
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