Mitsubishi Tanabe Pharma America, Inc. (MTPA) has announced it will present 11 scientific studies at the upcoming American Academy of Neurology (AAN) 2025 Annual Meeting, taking place April 5-9 in San Diego, California. The presentations will showcase the company's latest research in two key neurodegenerative disease areas: Parkinson's disease (PD) and amyotrophic lateral sclerosis (ALS).
"We are honored to join the scientific community at this year's AAN meeting, where we will discuss key insights from our clinical and real-world studies across PD and ALS," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "Our presence at the meeting, and the data presented, underscore our dedication to advancing impactful research and deepening our understanding of these progressive neurodegenerative diseases."
Parkinson's Disease Research Highlights
Two presentations will focus on investigational ND0612, a 24-hour continuous subcutaneous infusion of liquid levodopa/carbidopa being developed for Parkinson's disease patients experiencing motor fluctuations.
The first presentation, scheduled for April 9, will be delivered by Dr. Rajesh Pahwa from the University of Kansas Medical Center. This oral presentation will detail the impact of 24-hour treatment with ND0612 on PD motor state transitions throughout the day, based on findings from the pivotal Phase 3 BouNDless trial.
A second poster presentation by Dr. Harini Sarva from New York Presbyterian Hospital will examine quality of life outcomes in PD patients treated with ND0612, also derived from the Phase 3 BouNDless study.
This research builds on MTPA's recent presentations at the 2025 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD), where additional ND0612 data was shared, including subgroup analyses and one-year outcomes from the BouNDless trial's open-label extension phase.
Comprehensive ALS Research Program
The majority of MTPA's presentations will focus on ALS, with nine studies spanning clinical trials and real-world evidence.
RADICAVA ORS Clinical Studies
Three presentations will highlight findings from extension studies of RADICAVA ORS (edaravone), an oral suspension formulation approved by the FDA in 2022 for ALS treatment:
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Dr. Alejandro Salah will present final results from the MT-1186-A03 extension study, evaluating the safety and tolerability of RADICAVA ORS over 96 weeks in ALS patients.
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Dr. Stephen Apple will share findings from the MT-1186-A04 extension study, assessing continued efficacy and safety of RADICAVA ORS over an additional 48 weeks, comparing investigational daily dosing with the FDA-approved on/off regimen.
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A third presentation will examine the impact of RADICAVA ORS on survival and function in ALS patients, using propensity score matching to compare treated patients with historical controls from the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database.
Real-World Evidence in ALS
Six presentations will focus on real-world data, providing valuable insights into ALS management:
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Two studies will evaluate at-home telespirometry in ALS, examining changes in vital capacity measurements based on non-invasive ventilation status and assessing point-of-care quality classifications.
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An analysis of U.S. treatment utilization trends from 2016 to 2022 will highlight shifts in prescribing patterns, adoption of FDA-approved therapies, and the decreasing proportion of untreated patients.
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Additional presentations will examine referral patterns and healthcare utilization among ALS patients, compare demographics and resource utilization across specialty versus non-specialty treatment centers, and evaluate the application of a clinical algorithm to electronic medical records to reduce diagnostic and treatment delays.
RADICAVA ORS: Expanding Treatment Access
RADICAVA ORS received FDA approval in May 2022 for ALS treatment and was granted Orphan Drug Exclusivity in 2024 based on its major contribution to patient care by providing an oral suspension route of administration that avoids the burdens of IV administration.
The medication is taken daily for 14 consecutive days followed by a 14-day drug-free period for the initial treatment cycle. For subsequent cycles, it is taken for 10 days within a 14-day period followed by a 14-day drug-free period. Each 105 mg dose should be taken in the morning after overnight fasting, with no food or drink (except water) within one hour after administration.
To date, RADICAVA ORS and its IV formulation have been used to treat over 16,000 people with ALS in the United States, with more than 2 million days of therapy prescribed by over 2,400 healthcare providers.
About ND0612
ND0612 is an investigational drug-device combination therapy being developed as a 24-hour continuous subcutaneous infusion of liquid levodopa/carbidopa for treating motor fluctuations in people with Parkinson's disease. Development is being led by NeuroDerm, Ltd., a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation.
About Mitsubishi Tanabe Pharma America
Based in Jersey City, New Jersey, Mitsubishi Tanabe Pharma America, Inc. is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation. The company was established to develop and commercialize approved pharmaceutical products in North America, with a focus on neurodegenerative diseases and other areas of unmet medical need.
The AAN 2025 Annual Meeting represents an important opportunity for MTPA to share its latest research findings with the scientific community and continue advancing understanding of both Parkinson's disease and ALS, two devastating neurodegenerative conditions with significant unmet needs.
