Drug-Device Combo Therapy Under Review for Parkinson Disease

The Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for ND0612 for the treatment of motor fluctuations in patients with Parkinson disease.

ND0612 is an investigational drug-device therapy that provides a 24-hour continuous subcutaneous infusion of levodopa/carbidopa solution. The NDA is supported by data from the phase 3 BouNDless trial (ClinicalTrials.gov Identifier: NCT04006210), as well as long-term safety data from the ongoing phase 2b BeyoND study (ClinicalTrials.gov Identifier: NCT02726386).

Findings from the BouNDless study showed treatment with ND0612 resulted in a statistically significant addition of 1.72 hours in “ON” time without troublesome dyskinesia (primary endpoint; P <.0001) compared with oral levodopa/carbidopa. Additionally, patients treated with ND0612 experienced a 1.4-hour reduction in daily “OFF” time vs those who received oral levodopa/carbidopa (secondary endpoint; P <.0001).

In the open-label BeyoND trial, ND0612 was found to be well tolerated with most adverse events being mild or moderate in severity. Three-year results demonstrated a sustained reduction in daily “OFF” time (2.81 hours) with an improvement in daily “ON” time (2.79 hours) among patients treated with ND0612 (n=45).

“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 disease who continue to experience disruptive motor fluctuations,” said Yasutoshi Kawakami, President, Mitsubishi Tanabe Pharma America.

According to the Company, a regulatory decision is expected in the fourth quarter of 2025.

This article originally appeared on MPR