The New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) has been submitted to the Food and Drug Administration (FDA) for the treatment of motor fluctuations in patients with advanced Parkinson disease.
ABBV-951 is a solution of levodopa and carbidopa prodrugs for continuous subcutaneous (SC) infusion. The NDA submission is supported by data from the randomized, double-blind, double-dummy, active-controlled 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 from the study showed that treatment with ABBV-951 was associated with statistically superior reductions in motor fluctuations compared with oral levodopa/carbidopa. Patients in the ABBV-951 treatment arm achieved statistically significant increases in “on” time and decreases in “off” time compared with oral levodopa/carbidopa. These improvements were seen as early as the first week and persisted through week 12. The most common adverse reactions reported with ABBV-951 were infusion site reactions (erythema, pain, cellulitis, edema) and dyskinesia.
The NDA submission is also supported by data from an ongoing 52-week, multicenter, single-arm, open-label phase 3 study (ClinicalTrials.gov Identifier: NCT03781167) evaluating the safety and tolerability of ABBV-951 in patients with Parkinson disease.
AbbVie submits New Drug Application to US FDA for investigational ABBV-951 (foscarbidopa/foslevodopa) for the treatment of advanced Parkinson’s disease. News release. AbbVie. Accessed May 20, 2022. https://www.prnewswire.com/news-releases/abbvie-submits-new-drug-application-to-us-fda-for-investigational-abbv-951-foscarbidopafoslevodopa-for-the-treatment-of-advanced-parkinsons-disease-301551779.html?tc=eml_cleartime
This article originally appeared on MPR