NeuroBloc - botulinum toxin

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 to treat cervical dystonia (or torticollis), a disorder resulting from the contraction of the muscles in the neck that involves abnormal movements and twisting 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 administered by intramuscular injection by a specialist with experience in the treatment of cervical dystonia and in the use of botulinum toxins. The initial dose of NeuroBloc is 10,000 U equally distributed between the two to four muscles of the neck and shoulders 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 muscles to relax). 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 contraction." of the muscle where the injection was given, helping to relieve the symptoms of cervical dystonia. The effect of one injection of NeuroBloc gradually disappears over time.

How has NeuroBloc been studied?

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 only included patients who responded to type A toxin. was determined by measuring symptomatic changes (severity, pain and disability) after four weeks according to the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS).

What benefit has NeuroBloc shown during the studies?

After four weeks of treatment, NeuroBloc was shown to be significantly more effective than placebo in improving symptoms in all studies. NeuroBloc improved the scores of both patients not responding to botulinum toxin type A and those who responded. Most patients who had responded to NeuroBloc within the fourth week returned to their original condition 12-16 weeks after injection.

What is the risk associated with NeuroBloc?

The most common side effects with NeuroBloc (i.e. seen in more than 1 in 10 patients) are dry mouth, headache (in patients previously never treated with botulinum toxins), dysphagia (difficulty swallowing) and injection site reactions ( in patients previously treated with botulinum toxins). For the full list of 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 ingredients. NeuroBloc should not be used in patients with neuromuscular disorders (i.e. affecting the 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 a marketing authorization.
NeuroBloc was originally authorized "in exceptional circumstances" because the data available at the time of approval was limited. However, having in the meantime provided the additional data requested, the exceptional conditions ceased on July 8, 2005.

Other information about NeuroBloc:

On January 22, 2001, the European Commission issued a "Marketing Authorization" for NeuroBloc, valid throughout the European Union. The "Marketing Authorization" was renewed on January 22, 2006. Marketing Authorization Holder placing on the market is Eisai Ltd.
For the full version of NeuroBloc's EPAR, click here.

Last update of this summary: 12-2007.

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