News New Muscle Spasticity Therapy Under Priority Review by FDA New Muscle Spasticity Therapy Under Priority Review by FDA by Patricia Silva, PhD | November 2, 2015 Share this article: Share article via email Copy article link PathMaker Neurosystems Inc., a clinical-stage neuromodulation company focused on non-invasive therapies for neuromotor disorders, recently announced that the U.S. Food and Drug Administration (FDA) has granted the companyās MyoRegulatorā¢ PM-2200 systemĀ the Expedited Access Pathway (EAP) designation and priority processing status. The MyoRegulator is the first product of PathMaker and it is being developed for the treatment of muscle spasticity, a muscle control disorder characterized by muscle stiffness or tightness that causes an inability to control the affected muscles. Muscle spasticity is a condition associated with several neurological disorders including multiple sclerosis. The management of spasticity can be a challenge and it currently represents an unmet medical need. Surgical, physical and pharmacological treatments for spasticity have short-term efficacy, at best, and can cause some adverse effects. The MyoRegulator was developed based on the companyās proprietary DoubleStimā¢ technology, a system that provides simultaneous non-invasive stimulation at both the spinal and peripheral locations. The DoubleStimā¢ technology has so far yielded promising results as a therapy for plasticity. The company is planning to conduct human clinical trials soon to assess the clinical value of the MyoRegulator system. āThe EAP designation for MyoRegulator is significant, as FDA reserves this priority review program only for devices with demonstrated potential to fill an unmet medical need and benefit patient health,ā said Sheila Hemeon-Heyer, J.D., Vice President of Regulatory and Clinical Affairs at PathMaker Neurosystems in a companyĀ news release. āWe are excited to be working with FDA through the EAP program to rapidly bring to patients this important new technology for treating spasticity.ā EXCLUSIVE: Genentech/Roche Interview with MS News Today on Promising MS Therapy Ocrelizumab The EAP is a new program from the FDA, established in April 2015, with the purpose of helping patients obtain rapid access to important new medical devices by accelerating their development, assessment, and review. The MyoRegulator received the EAP designation based on its intent to treat a debilitating condition and due to the fact that it offers clinically significant benefits in comparison to other existing alternatives. āThrough the FDA Expedited Access Pathway program, we will be able to more rapidly bring to market this breakthrough technology for treating muscle tone disorders,ā concluded Dr. Nader Yaghoubi, President and Chief Executive Officer of PathMaker. āAs one of the first companies selected into this program, we look forward to working with FDA to rapidly make MyoRegulator available to patients and clinical institutions worldwide.ā Print This Page About the Author Patricia Silva, PhD PatrĆcia holds a PhD in medical microbiology and infectious diseases from the Leiden University Medical Center, Netherlands, and completed a postdoctoral research fellowship at the Instituto de Medicina Molecular, Lisbon, Portugal. Her work in academia was mainly focused on molecular biology and the genetic traits of infectious agents such as viruses and parasites. PatrĆcia earned several travel awards to present her work at international scientific meetings. She is a published author of several peer-reviewed science articles. Tags FDA, MyoRegulator, spasticity
April 24, 2024 News by Lindsey Shapiro, PhD Autoantibodies seen in blood years before MS diagnosis: Study
April 23, 2024 News by Mary Chapman Itās year 10 for MSAAās upcoming Improving Lives Benefit for MS
April 23, 2024 News by Margarida Maia, PhD AAN 2024: Subcutaneous Ocrevus led to nearly no relapses after year