FDA Requests Device Info for Novel Parkinson Disease Infusion Therapy

The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to AbbVie regarding the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson disease.

ABBV-951 is a solution of levodopa and carbidopa prodrugs for continuous subcutaneous (SC) delivery. The NDA submission was supported by data from the M15-736 study (ClinicalTrials.gov Identifier: NCT04380142), which compared ABBV-951 administered via continuous SC infusion for 24 hours/day to oral immediate-release levodopa/carbidopa in 130 patients aged 30 years and older with advanced Parkinson disease. Findings showed that treatment with ABBV-951 was associated with statistically superior reductions in motor fluctuations compared with oral levodopa/carbidopa.

In the CRL, the FDA requested that additional information about the infusion pump be provided as part of the NDA review. AbbVie plans to resubmit the application quickly as no additional efficacy or safety trials related to the drug were required.

“There is an unmet need for people living with advanced Parkinson disease as they face daily challenges in managing their condition,” said Thomas Hudson, MD, senior vice president, research and development, chief scientific officer, AbbVie. “We will continue to work closely with the FDA as part of our commitment to bringing this treatment option to people impacted by this disease as quickly as possible.”

This article originally appeared on MPR