Presentations will highlight findings from studies evaluating investigational ND0612 in Parkinson's disease and RADICAVA® (edaravone) formulations in ALS
JERSEY CITY, N.J., April 3, 2025 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) announced 11 presentations will be shared at the American Academy of Neurology (AAN) 2025 Annual Meeting, taking place April 5-9 in San Diego, CA, and online. The presentations will discuss two posters in Parkinson's disease (PD) and nine in 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, 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."
PD data to be presented at the meeting include:
Investigational ND0612:
Presentations will highlight findings from the pivotal Phase 3 BouNDless trial (NCT04006210), including an oral presentation detailing the impact of 24-hour treatment with ND0612 on PD motor state transitions throughout the day, as well as an analysis of quality of life outcomes in people with PD experiencing motor fluctuations.
- Impact of 24-hour Subcutaneous Levodopa/Carbidopa Infusion (ND0612) on Motor Function: Efficacy Outcomes from the Phase 3 BouNDless Study (Rajesh Pahwa, M.D.; University of Kansas Medical Center)
Scientific Platform Session S37 (#001): 1:00 p.m. – 1:12 p.m. PDT, April 9
- Quality of Life With 24-hour Subcutaneous Levodopa/Carbidopa Infusion (ND0612): QoL Results from a Phase 3, Randomized, Active-Controlled Study (Harini Sarva, M.D., FAAN; New York Presbyterian Hospital)
Poster Session P11 (#5-007): 8:00 a.m. – 9:00 a.m. PDT, April 9
ALS data to be presented at the meeting include:
RADICAVA ORS Studies:
A presentation will share final results from the MT-1186-A03 extension study, which evaluated the safety and tolerability of RADICAVA ORS® (edaravone) over 96 weeks in ALS patients who had previously participated in MT-1186-A01. Additionally, findings from the MT-1186-A04 extension study will be presented, assessing the continued efficacy and safety of RADICAVA ORS over an additional 48 weeks, comparing investigational daily dosing with the U.S. Food and Drug Administration (FDA)-approved on/off regimen. Lastly, an analysis will examine the impact of RADICAVA ORS on survival and function in ALS patients, leveraging data from the Pooled Resource Open-Access ALS Clinical Trials (PRO-ACT) database and propensity score matching to compare RADICAVA ORS-treated patients with participants from studies MT-1186-A01 through A04.
- Phase 3, Open-Label, Safety Extension Study of Oral Edaravone (Radicava ORS®) Administered Over 96 Weeks in Patients with ALS (MT-1186-A03) (Alejandro Salah, M.D., Ph.D., MBA, MHA; MTPA)
Scientific Platform Session S27 (#007): 2:12 p.m. – 2:24 p.m. PDT, April 8
- Extension Study MT-1186-A04 Evaluating Oral Edaravone (Radicava ORS®) Continued Efficacy and Safety up to an Additional 48 Weeks in Patients With ALS (Stephen Apple, M.D.; MTPA)
Poster Session P9 (#2-007): 11:45 a.m. – 12:45 p.m. PDT, April 8
- Long-term Function and Survival of Radicava ORS® (Oral Edaravone)-Treated Patients With ALS vs Propensity Score–Matched PRO-ACT Historical Controls (Alejandro Salah, M.D., Ph.D., MBA, MHA; MTPA)
Poster Session P8 (#2-003): 8:00 a.m. – 9:00 a.m. PDT, April 8
Real-World Data:
Multiple posters highlighting real-world data will be presented, including two studies evaluating at-home telespirometry in ALS. One examines changes in erect and supine slow vital capacity based on non-invasive ventilation (NIV) status, while the other assesses point-of-care quality classifications for slow and forced vital capacity measurements. Additionally, an analysis of real-world data will examine trends in ALS treatment utilization in the U.S. from 2016 to 2022, highlighting shifts in prescribing patterns, adoption of FDA-approved therapies and the decreasing proportion of untreated patients. Other presentations include an analysis of referral patterns and healthcare utilization among people with ALS enrolled in the OPTUM claims database, a secondary analysis describing demographics and healthcare resource utilization across specialty vs. non-specialty treatment centers, and the application of a clinical algorithm to electronic medical records to reduce the delay in time to diagnosis and treatment for patients with ALS.
- Smartphone─Mediated At-Home Telespirometry Erect and Supine Slow Vital Capacity Decline Differences Based On NIV Status in Subjects With ALS (Stephen Apple, M.D.; MTPA)
Poster Session P8 (#2-004): 8:00 a.m. – 9:00 a.m. PDT, April 8
- Smartphone─Mediated, At-Home Telespirometry Vital Capacity (VC) Measurements in ALS: Point-of-Care Quality Assessment for Slow VC and Forced VC (Stephen Apple, M.D.; MTPA)
Poster Session P8 (#2-006): 8:00 a.m. – 9:00 a.m. PDT, April 8
- Evolution of the Treatment Landscape for Patients Diagnosed with Amyotrophic Lateral Sclerosis in the United States (Malgorzata Ciepielewska, M.S.; MTPA)
Poster Session P9 (#2-006): 11:45 a.m. – 12:45 a.m. PDT, April 8
- Referral Patterns for Patients With Amyotrophic Lateral Sclerosis Enrolled in a US-Based Administrative Claims Database (Malgorzata Ciepielewska, M.S.; MTPA)
Poster Session P8 (#2-009): 8:00 a.m. – 9:00 a.m. PDT, April 8
- Treatment of Amyotrophic Lateral Sclerosis in General and Specialist US Healthcare Settings: Results From a Real-World Survey (Malgorzata Ciepielewska, M.S.; MTPA)
Poster Session P8 (#2-012): 8:00 a.m. – 9:00 a.m. PDT, April 8
- Application of a Clinical Algorithm on Real-World Electronic Medical Record Data to Assist With Earlier Detection of Amyotrophic Lateral Sclerosis (Amanda E. Fiander, M.D., FRCPC, CSCN (EMG); Maritime Neurology)
Poster Session P8 (#2-010): 8:00 a.m. – 9:00 a.m. PDT, April 8
About RADICAVA ORS® (edaravone)
The U.S. Food and Drug Administration (FDA) approved RADICAVA ORS® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). In 2024, the FDA granted RADICAVA ORS Orphan Drug Exclusivity based on its major contribution to patient care by providing an oral suspension route of administration that avoids the burdens of IV administration. RADICAVA ORS is taken daily for 14 consecutive days followed by a 14-day drug-free period for the initial treatment cycle. For subsequent treatment cycles, RADICAVA ORS is taken for 10 days within a 14-day period followed by a 14-day drug-free period. Each 105 mg (5mL) dose of RADICAVA ORS should be taken in the morning after overnight fasting. Patients should not eat or drink (except water) within one hour after taking RADICAVA ORS.1
Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc. (MTPA). The MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, edaravone was approved as RADICUT® for the treatment of ALS in Japan and South Korea. Marketing authorizations were subsequently granted in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021), Malaysia (December 2021) and Brazil (February 2024). Marketing authorization for RADICAVA® Oral Suspension was granted in Canada (November 2022) and Switzerland (May 2023), and RADICUT® Oral Suspension 2.1% was granted regulatory approval in Japan in December 2022. To date, in the U.S., RADICAVA ORS, along with the previously available IV RADICAVA® (edaravone), have been used to treat over 16,000 people with ALS, with over 2.0-million days of therapy, and have been prescribed by over 2,400 HCPs.2-4
INDICATION
RADICAVA ORS® (edaravone) is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
IMPORTANT SAFETY INFORMATION
Hypersensitivity Reactions
RADICAVA ORS® (edaravone) is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred.
Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA ORS, treat per standard of care, and monitor until the condition resolves.
Sulfite Allergic Reactions
RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people.
Adverse Reactions
The most common adverse reactions (≥10%) reported in RADICAVA® (edaravone)-treated patients and at least 2% more frequently than placebo were contusion (15% vs 9%), gait disturbance (13% vs 9%), and headache (10% vs 6%), respectively. In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.
Pregnancy
Based on animal data, RADICAVA ORS may cause fetal harm.
To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see the full Prescribing Information, also available at www.RADICAVAORS.com.
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.
Media inquiries:
Media_MTPA@mt-pharma-us.com
1 RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022
2 Data on file. Mitsubishi Tanabe Pharma America, Inc.
3 Data on file. Mitsubishi Tanabe Pharma America, Inc.
4 Data on file. Mitsubishi Tanabe Pharma America, Inc.
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