What is NeuroBloc?
NeuroBloc is a solution for injection containing the active substance botulinum toxin type B (5000 units [U] per milliliter).
What is NeuroBloc used for?
NeuroBloc is used in the treatment of cervical dystonia (or stiff neck), a disorder resulting from the contraction of the neck muscles which involves abnormal movements and torsion of the neck and an unusual position of the head.
The medicine can only be obtained with a prescription.
How is NeuroBloc used?
NeuroBloc should only be given by intramuscular injection by a specialist experienced in the treatment of cervical dystonia and the use of botulinum toxins. The initial dose of NeuroBloc is 10, 000 U equally distributed between the two-four neck and shoulder muscles most affected. The dose and number of injections depend on the patient's response.
How does NeuroBloc work?
The active ingredient in NeuroBloc, botulinum toxin type B, is a muscle relaxant (a substance that causes muscle relaxation). Botulinum toxin type B is a toxic substance produced by the bacterium Clostridium botulinum . It is the bacterium that causes botulism, a food poisoning that involves muscle weakness and paralysis. The toxin reduces the release of acetylcholine, a chemical messenger that induces muscle contraction. Injection of NeuroBloc directly into the muscle reduces or inhibits the contraction of the muscle at the point where the injection was made, helping to alleviate the symptoms of cervical dystonia. The effect of a NeuroBloc injection gradually disappears over time.
What studies have been carried out on NeuroBloc?
NeuroBloc was compared with placebo (a dummy treatment) in four studies involving a total of 392 adults with cervical dystonia. Three of the studies included patients who no longer responded to botulinum toxin type A (another type of botulinum toxin that can also be used to treat cervical dystonia), while the fourth study included only patients who responded to type A toxin. was determined by measuring changes at the symptomatic level (severity, pain and disability) after four weeks according to the TWSTRS scale (Toronto Western Spasmodic Torticollis Rating Scale).
What benefit has NeuroBloc shown during the studies?
After four weeks of treatment, NeuroBloc was shown to be significantly more effective than placebo at improving symptoms in all studies. NeuroBloc improved the score of both patients not responding to botulinum toxin type A and those responding. Most of the patients who had had a NeuroBloc response within week 4 returned to their original condition 12-16 weeks after the injection.
What is the risk associated with NeuroBloc?
The most common side effects of NeuroBloc (ie seen in more than 1 patient in 10) are dry mouth, headache (in patients previously never treated with botulinum toxins), dysphagia (difficulty swallowing) and reactions at the injection site ( in patients previously treated with botulinum toxins). For the full list of all side effects reported with NeuroBloc, see the Package Leaflet.
NeuroBloc should not be used in patients who may be hypersensitive (allergic) to botulinum toxin or any of the other components. NeuroBloc should not be used in patients with neuromuscular disorders (ie those affecting nerves and muscles).
Why has NeuroBloc been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that NeuroBloc's benefits are greater than its risks in the treatment of cervical dystonia (torticollis), and recommended that NeuroBloc be given marketing authorization.
Originally NeuroBloc was authorized "in exceptional circumstances" because the data available at the time of approval were limited. However, having in the meantime the company provided the additional data requested, the exceptional conditions disappeared on 8 July 2005.
More information about NeuroBloc:
On 22 January 2001, the European Commission issued a marketing authorization for NeuroBloc, valid throughout the European Union. The marketing authorization was renewed on 22 January 2006. The marketing authorization holder is Eisai Ltd.
For the full EPAR for NeuroBloc, click here.
Last update of this summary: 12-2007.
