Mallinckrodt plc announces positive top-line findings from its observational registry assessing relapse recovery in multiple sclerosis relapse patients treated with acthar® gel
Mallinckrodt plc announced positive top-line findings from its observational registry to assess treatment patterns and response to acthar® gel (repository corticotropin injection) in reducing the clinical impact of disease exacerbations in patients with multiple sclerosis (ms) relapse. the results for the main subsets of patients are highly statistically significant for all the efficacy endpoints. mallinckrodt plans to share the data at an upcoming medical meeting. ms is a chronic, degenerative disease that can cause numerous impairments, including fatigue, balance/coordination issues, numbness or tingling, vision problems, muscle spasms, tremors and emotional changes, and some people with ms experience relapses while on standard therapies. acthar gel is u.s. food and drug administration (fda)-approved for the treatment of acute exacerbations of ms in adults. controlled clinical trials have shown acthar gel to be effective in speeding the resolution of acute exacerbations of ms. however, there is no evidence that it affects the ultimate outcome or natural history of the disease. please see important safety information for acthar gel below. the registry was designed to assess the characteristics of patients receiving acthar gel for ms exacerbations (sometimes referred to as "flares" or "relapses"), as well as the outcome at two months and whether or not the outcome was maintained at six months. the average age of patients was 47 years, and the mean duration of ms was 10 years at the start of the study. registry data showed that patients treated with acthar gel reported significant improvements in symptoms associated with ms exacerbations at two months from baseline, as measured by the ms impact scale, version 1 (msis 29v1), the primary measure of the study. the response was sustained at six months. physicians also reported an improvement in physical symptoms in patients treated with acthar gel, based on expanded disability status scale (edss) scores.
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