Phase III trials show Dysport offers benefits in Cervical Dystonia-Ipsen Pharma

Data from a Phase III, randomized, double-blind, placebo-controlled study shows that Dysport (botulinum toxin A), from Ipsen Pharmaceuticals, is effective with a favorable safety profile in the treatment of Cervical Dystonia, versus placebo at four (primary endpoint), eight and 12 weeks post injection. Efficacy was measured using the Toronto Western Spasmodic Torticollis Rate Scale (TWSTRS) total score and subscales (disability, severity and pain) as well as several investigator-led assessments. The data showed that significant improvement in TWSTRS total score versus placebo (-14.0 vs baseline for Dysport and -3.9 versus baseline for placebo, p<0.05)) at the week 4 primary endpoint. The significant improvement associated with Dysport treatment on TWSTRS total score was sustained at week 8 and week 12 assessments. Adverse events were experienced by 37.8% of patients receiving Dysport and 25.5% of patients receiving placebo during the single treatment cycle in the trial.

In addition, data from another Phase III study shows Dysport improves disease-specific quality of life in patients with Cervical Dystonia, as measured by Patient-Reported Outcomes. This showed that with one single injection, results at week 4 showed total Cervical Dystonia Impact Profile (CDIP)-58 score was improved as were all eight CIPD-58 subscales (head and neck symptoms, pain and discomfort, sleep, upper limb activities, walking, annoyance, mood and psychosocial functioning) and visual analog scales for pain and symptoms. Data were presented at the Annual Assembly of the Academy of Physical Medicine and Rehabilitation.