Acthar Gel (repository corticotropin injection) leads to significant improvements after two months of use in people with multiple sclerosis (MS) still having acute relapses despite treatment, and who failed to respond to other high-dose corticosteroids, topline data from an observational study show.
The gel’s developer, Mallinckrodt Pharmaceuticals, also announced that its OPTIONS trial, evaluating the safety of Acthar Gel in relapsing-remitting MS (RRMS) patients who have not responded to treatment with high-dose steroids — a standard of care treatment — is now about half enrolled.
These findings were presented in two posters at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2020 that ran in Florida on Feb. 27–29.
Acthar Gel is currently approved by the U.S. Food and Drug Administration (FDA) for several indications, including the treatment of acute MS flares (disease exacerbations) in adults with frequent and recurring relapses.
The gel consists of adrenocorticotropic hormone (ACTH), and can be injected under the skin (subcutaneously) or into the muscle (intramuscular). It works by enhancing the production of steroids in the body to reduce inflammation and more rapidly resolve a disease relapse.
In MS, treatment that can effectively prevent a relapse is critical for minimizing disability.
Mallinckrodt conducted an observational registry study (NCT02633033) to monitor the course of MS, and to document relapses and the recovery process, in a group of MS patients treated with Acthar Gel.
Its findings were presented at ACTRIMS in the poster “Topline Results Of A Prospective Observational Registry Of Repository Corticotropin Injection For The Treatment Of Multiple Sclerosis Relapse.”
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