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Medical Areas: Musculoskeletal | Neurology
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Elan Pharmaceuticals
Approval Status: Approved December 2000
Treatment Area: Cervical dystonia
Myobloc, a sterile liquid formulation of purified neurotoxin,
has been approved as an injectable solution for the treatment of
abnormal head position and neck pain associated with cervical
dystonia. Myobloc is available in three vial configurations of 2500
Units, 5000 Units, and 10000 Units, offering convenience and
flexibility for dosing.
Cervical dystonia, also known as spasmodic torticollis, is a
neurological disorder that affects the cervical area of the spine.
It causes the neck and shoulder muscles to contract involuntarily,
resulting in painful muscle spasms that often make daily
functioning difficult. Myobloc is the first FDA approved drug for
treatment of cervical dsytonia.
Myobloc has been evaluated in two phase III studies involving a
total of 186 adult subjects. The primary efficacy outcome of the
trials was the Toronto Western Spasmodic Torticollis Rating Scale,
which examines the severity of abnormal head position, the severity
and duration of pain, and the disabiling effects placed on the
person's activities. Subjects were randomized to receive
placebo, 5000 Units, or 10000 Units in single treatment sessions
and were evaluated for 16 weeks following injection.
There were no statistically significant differences between the
5000 U and the 10000 U doses. Most subjects who reported
improvements after four weeks had returned to their baseline status
by the end of the 16 weeks. Subjects in the two treatment groups
did experience decreases in pain, though many also reported
increases in symptoms regardless of receiving treatment or
placebo.
Adverse events associated with the use of Myobloc may include
(but are not limited to) the following:
- Dry mouth
- Dysphagia
- Injection site pain
- Dyspepsia
- Headache
Botulinum Toxin Type B is a sterile liquid formulation of a
purified neurotoxin that acts at the neuromuscular junction to
produce flaccid paralysis. The solution is injected directly into
the muscle.
For additional information on Myobloc, please visit
Myobloc.