dystonia
By Jenny Powers PARIS -- June 10, 2009 -- The results of the longest safety study of botulinum toxin type B (BoNT-B) concluded to date were reported here today at the Movement Disorder Society's (MDS) 13th International Congress of Parkinson's Disease and Movement Disorders. This follow-up study determined that continuous treatment with BoNT-B for cervical dystonia was safe up to a year interval and that benefit remained consistent over this time period. William Birmingham and Edgar Salazar-Grueso, Solstice Neurosciences, Malvern, Pennsylvania, presented the findings here on June 8. The investigators analysed the results of a 7-year cervical dystonia safety study of BoNT-B conducted on 502 patients who were enrolled to determine the safety, efficacy, and immunogenicity of repeat doses, according to a US postapproval commitment. This multicentre, open-label study included serotype A responsive (n = 454) or unresponsive (n = 48) patients and data recorded included staff safety assessments, patient-rated efficacy scores, and serum samples for neutralising antibodies. Mean patient age was 54 years; the majority of patients were white (96%) and female (68%). BoNT-B was administered at a mean dose of 16,227 U; the median was 17,500 U (min 5,000 U, max 25,000 U), with a mean time between injections of 91.33 +- 31 days. The mean duration of treatment was 3.4 years or about 14 treatment sessions. Most subjects reported that their symptoms were improved at all treatment sessions. The most frequently reported adverse events were mild to moderate dry mouth or dysphagia which was experienced by 63% and 26.1% of patients, respectively. No events of aspiration, aspiration pneumonia, or botulism were reported. Five treatment-related serious adverse events were reported; 29 patients withdrew due to adverse events, 14 of which were determined to be treatment-related. Five nontreatment related deaths occurred during the course of this study. All laboratory tests, physical and neurological examinations, and vital signs revealed no BoNT-B associated findings, however immunogenicity data is not yet completed. The investigators concluded that treatment of cervical dystonia with repeated doses of BoNT-B to be safe and well tolerated. Moreover, the beneficial effect of treatment continued with long-term treatment. Funding for this study support was provided by Solstice Neurosciences, Inc. [[Presentation title: Long-Term (7-Year) Cervical Dystonia Safety Study With Myobloc. Abstract MO-57]
