MTPA’s ND0612 NDA OKAY'd by FDA
What Is ND0612?
ND0612 is an investigational treatment for Parkinson’s disease (PD) that delivers a continuous 24-hour infusion of liquid levodopa/carbidopa (LD/CD) under the skin using a small, wearable pump. This method aims to provide more consistent medication levels compared to traditional oral pills, which can lead to fluctuations in movement control.
How Does It Work?
Traditional oral LD/CD treatments can result in "motor fluctuations," where symptoms like stiffness or slowness return between doses due to inconsistent absorption in the digestive system. ND0612 bypasses the gastrointestinal tract, delivering medication directly into the bloodstream, potentially reducing these fluctuations and providing more stable symptom control.
What Do the Studies Show?
BouNDless Trial (Phase 3): This major study found that ND0612 increased "good ON" time (periods when symptoms are well-controlled without troublesome side effects) by an average of 1.72 hours per day compared to standard oral medication. It also reduced "OFF" time by about 1.4 hours daily.
BeyoND Study (Long-Term Safety): Over several years, ND0612 continued to show benefits, with many patients experiencing fewer motor fluctuations and improved daily functioning. Side effects were mostly mild, such as skin reactions at the infusion site.
What's Next?
As of May 28, 2025, the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for ND0612. A decision is expected in the fourth quarter of 2025.
Why Is This Important?
If approved, ND0612 could offer a less invasive and more consistent treatment option for people with Parkinson’s disease, helping them manage their symptoms more effectively and improve their quality of life.
