JERSEY CITY, N.J., May 28, 2025 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) resubmission for investigational ND0612, a 24-hours/day, continuous, subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD), for the treatment of motor fluctuations in people living with Parkinson's disease (PD). The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date in the fourth quarter of 2025.
"The FDA's acceptance of the NDA for ND0612 is a critical milestone that brings us one step closer to delivering a potential therapeutic option for people with Parkinson's disease who continue to experience disruptive motor fluctuations," said Yasutoshi Kawakami, President, MTPA. "This progress is a testament to MTPA's ongoing efforts in support of individuals in the U.S. impacted by this progressive neurodegenerative disorder."
The NDA is supported by data from the pivotal, Phase 3, multi-center, randomized, double-blind double-dummy (DBDD) BouNDless trial (NCT04006210), which evaluated the effectiveness and safety of ND0612 in people with PD experiencing motor fluctuations, as well as long-term safety data from the ongoing Phase 2b BeyoND study (NCT02726386) of ND0612, with some study participants in their eighth year of follow-up.
NeuroDerm, Ltd., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) based in Israel, led the clinical development of ND0612. If approved by the FDA, MTPA will commercialize ND0612 in the U.S.
About ND0612
ND0612 is an investigational drug-device combination therapy – a 24-hours/day, continuous subcutaneous (SC) infusion of liquid levodopa/carbidopa (LD/CD) for the treatment of motor fluctuations in people with Parkinson's disease (PD). Development of investigational ND0612 is being led by NeuroDerm, Ltd., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC).
About Mitsubishi Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on X (formerly Twitter), Facebook and LinkedIn.
About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC) is one of the oldest pharmaceutical companies in the world, founded in 1678, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MTPC sets the MISSION of "Creating hope for all facing illness". To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on "precision medicine" to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety. In addition, MTPC is working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to https://www.mt-pharma.co.jp/e/
About NeuroDerm, Ltd.
NeuroDerm, Ltd. is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), based in Israel, inspired to reduce disease burden and improve the quality of life of patients and their families through innovative drug-device combination therapies and technologies. NeuroDerm is an integrated pharmaceutical and medical technology company developing central nervous system (CNS) product candidates. For additional information, please visit NeuroDerm's website at www.neuroderm.com or follow the Company on LinkedIn.
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SOURCE Mitsubishi Tanabe Pharma America
