News FDA Will Review Arbaclofen ER, Potential Oral Therapy for MS Spasticity FDA Will Review Arbaclofen ER, Potential Oral Therapy for MS Spasticity by Joana Carvalho, PhD | July 22, 2020 Share this article: Share article via email Copy article link The U.S. Food and Drug Administration (FDA) has agreed to review Ā Osmotica Pharmaceuticals‘ amended request for the approval of arbaclofen extended release (ER) tablets to treatĀ spasticity in people with multiple sclerosis (MS), the company announced. The regulatory agency found that theĀ new drug applicationĀ addressed all issues raised in a July 2016 action letter response to the companyās original NDA. An FDA decision is expected byĀ Dec. 29, 2020. Arbaclofen ER (brand name,Ā Ontinua ER) is an extended release formulation of arbaclofen, a compound similar to the muscle relaxant baclofen that is approved to treat spasticity (muscle stiffness) in people with MS, spinal cord injuries, or other disorders involving the spinal cord. This extended release formulation, which is based on Osmoticaās proprietary Osmodex drug delivery technology, allows arbaclofen to be slowly released over longer periods of time, potentially reducing dosing frequency and undesirable side effects. The amended application is supported by data from the Phase 3 OS440-3004 trial (NCT03290131) and its open-label, long-term extension study (NCT03319732), which investigated the safety and effectiveness of arbaclofen ER at alleviating spasticity in MS patients. Findings from OS440-3004 showed that when given as a daily 40 mg or 80 mg tablet, arbaclofen ER lowered patientsā TNmAS-MAL scores, a well-established measure of muscle spasticity, from the studyās start to day 84 compared with placebo. Most patients who participated and completed OS440-3004 enrolled in its long-term extension study, OS440-3005, and completed one year of treatment with the highest arbaclofen ERĀ dose, 80 mg daily. Results from theĀ extension study showed that patients takingĀ arbaclofen ER tablets dailyĀ continued with improvements in their TNmAS-MALĀ scores, demonstrating the medicationās long-term effectiveness at alleviating spasticity. During this study, arbaclofen ER was also found to be safe and generally well-tolerated. Findings from OS440-3004 and OS440-3005 were also consistent with data from an earlier Phase 3 trial of arbaclofen ER, called OS440-3002 (NCT01743651), which showed that when given at a daily dose of 40 mg the therapy was more effective at lowering patientsā TNmAS-MAL scores than placebo, and similarly effective to an 80 mg dose of baclofen. Patients givenĀ baclofenĀ also experienced more frequent side effects, including dizziness and drowsiness, than those in the trial group usingĀ arbaclofen ER. Print This Page About the Author Joana Carvalho, PhD Joana holds a bachelorās in biology, a Master of Science in evolutionary and developmental biology, and a PhD in biomedical sciences from Universidade de Lisboa, Portugal. Her work has been focused on the impact of non-canonical Wnt signaling in the collective behavior of endothelial cells ā those that make up the lining of blood vessels ā found in the umbilical cord of newborns. In addition to several research fellowships, she was awarded two Erasmus scholarships to conduct part of her studies in France. Tags baclofen, FDA, spasticity
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