Healthcare Industry News: cervical dystonia
News Release - February 8, 2008
Solstice Neurosciences, Inc. Issues Corporate Response to FDA Early CommunicationMALVERN, Pa., Feb. 8 (HSMN NewsFeed) -- Safety of patients treated with Myobloc® (Botulinum Toxin Type B) Injectable Solution has always been of primary importance for Solstice Neurosciences, Inc. ("Solstice"). We support education and training of physicians in a number of ways regarding the proper use of this product as outlined in the prescribing information.
We maintain a rigorous and routine process for monitoring and reporting any adverse events to regulatory authorities in compliance with all applicable regulations.
Manufacturers of botulinum toxin products have recently submitted safety information to the FDA. In its review of this information and other available data, the Agency's posting of this Early Communication "does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue."
Solstice supports the FDA review of botulinum toxins and remains committed to providing FDA with any additional information needed.
MYOBLOC was the first drug approved in the US to reduce the severity of abnormal head position and the neck pain associated with cervical dystonia. When injected into an affected muscle, botulinum toxin type B inhibits the release of the neurotransmitter, acetylcholine, at the motor nerve terminals to allow it to relax.
Regulatory approvals in the US, EU and Canada were based on the results from randomized, multi-center, double-blind, placebo-controlled studies in adult patients with cervical dystonia.
MYOBLOC is supplied as a ready-to-use, injectable solution in three single-dose vial sizes of 0.5 mL (2,500 U), 1.0 mL (5,000 U), and 2.0 mL (10,000 U). Unopened vials of MYOBLOC have demonstrated stability when stored at 2-8 degrees Celsius, and are approved for a 36-month shelf life in the EU, and a 48-month shelf-life in the US and Canada.
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 is 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
Myobloc® is a registered trademark of Solstice Neurosciences, Inc.
Source: Solstice Neurosciences
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