Cervical dystonia, (spasmodic torticollis), is a focal dystonia in which patients experience the involuntary contraction of muscles in the neck, leading to abnormal movements and posture. Botox, produced by the pharmaceutical company Allergan, is a botulinum toxin type A, and is currently considered to be the most effective treatment for the disorder.
Myobloc, known as NeuroBloc in Europe, is the only botulinum type B toxin currently available for the treatment of neck pain associated with cervical dystonia. It is approved for use in the US, Canada and Europe. Solstice purchased the drug from Elan Biopharmaceuticals in 2004.
Results from a randomized, double-blind trial of 111 toxin-naive patients with cervical dystonia (CD), found Myobloc to be clinically equivalent to Botox for efficacy as measured by a validated rating instrument for duration of response.
“The FDA approved Myobloc for CD after an extensive clinical trial program of 9 trials over 7 years. The current data support and expand on previously published reports demonstrating that Myobloc is a safe and effective first-line treatment for patients with CD. Pain relief and muscle relaxation are key treatment objectives in patients with CD and Myobloc has a proven track record of efficacy,” said Mike Royal, chief medical officer for Solstice. Mr Royal would like Myobloc to be considered as a first-line therapy for CD.
The most frequently reported adverse events with Myobloc are dry mouth, dysphagia, dyspepsia, and injection site pain. These adverse events are generally mild to moderate, transient, self-resolving, and more common with higher dosages.