Solstice Neurosciences, Inc. Issues Corporate Response to FDA Early Communication
We maintain a rigorous and routine process for monitoring and reportingany adverse events to regulatory authorities in compliance with all applicableregulations.
Manufacturers of botulinum toxin products have recently submitted safetyinformation to the FDA. In its review of this information and other availabledata, the Agency's posting of this Early Communication "does not mean that FDAhas concluded there is a causal relationship between the drug products and theemerging safety issue."
Solstice supports the FDA review of botulinum toxins and remains committedto providing FDA with any additional information needed.
MYOBLOC was the first drug approved in the US to reduce the severity ofabnormal head position and the neck pain associated with cervical dystonia.When injected into an affected muscle, botulinum toxin type B inhibits therelease of the neurotransmitter, acetylcholine, at the motor nerve terminalsto allow it to relax.
Regulatory approvals in the US, EU and Canada were based on the resultsfrom randomized, multi-center, double-blind, placebo-controlled studies inadult patients with cervical dystonia.
MYOBLOC is supplied as a ready-to-use, injectable solution in threesingle-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 storedat 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 biopharmaceuticalcompany focused on the development, manufacturing, sales and marketing ofspecialty products. Solstice's first product, MYOBLOC, represents the onlybotulinum toxin type B currently available to physicians and patientsworldwide. 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 indicatedfor the treatment of patients with cervical dystonia (CD) to reduce theseverity of abnormal head position and pain associated with CD. For moreinformation about Solstice Neurosciences, Inc., visit www.solsticeneuro.com
Myobloc(R) is a registered trademark of Solstice Neurosciences, Inc.
SOURCE Solstice Neurosciences, Inc.
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