Positive results were announced from a phase 3 study evaluating the efficacy and safety of ABBV-951 (foslevodopa/foscarbidopa) in patients with advanced Parkinson disease.
ABBV-951 is a solution of levodopa and carbidopa prodrugs for continuous subcutaneous infusion. The randomized, double-blind, double-dummy, active-controlled study (ClinicalTrials.gov Identifier: NCT04380142) compared ABBV-951 via continuous subcutaneous infusion for 24 hours/day to oral levodopa/carbidopa in 130 patients aged 30 years and older with advanced Parkinson disease.
Patients were provided with a home diary to assess their motor status. The primary endpoint was the change in “on” time without troublesome dyskinesia at 12 weeks based on the Parkinson disease diary.
Results showed that treatment with ABBV-951 was associated with statistically superior reductions in motor fluctuations compared with oral levodopa/carbidopa. At week 12, patients in the ABBV-951 treatment arm had an increase in “on” time of 2.72 hours compared with 0.97 hours for oral levodopa/carbidopa (P =.0083).
Moreover, patients in the ABBV-951 arm had a decrease in “off” time of 2.75 hours compared with 0.96 hours for oral levodopa/carbidopa (P =.0054). These improvements in “on” and “off” time 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, bruising, hemorrhage, nodule, induration, infection, and pruritus), dyskinesia, “on” and “off” phenomenon, fall, hallucinations (including visual hallucination), balance disorders, constipation and peripheral swelling.
Data from the phase 3 trial will be presented at a future medical meeting and is expected to be part of global regulatory submissions.
AbbVie announces ABBV-951 (foslevodopa/foscarbidopa) showed improvement in controlling motor fluctuations compared to oral levodopa/carbidopa medication in pivotal phase 3 trial in patients with advanced Parkinson’s disease. News release. AbbVie. Accessed October 28, 2021. https://www.prnewswire.com/news-releases/abbvie-announces-abbv-951-foslevodopafoscarbidopa-showed-improvement-in-controlling-motor-fluctuations-compared-to-oral-levodopacarbidopa-medication-in-pivotal-phase-3-trial-in-patients-with-advanced-parkinsons-disease-301410482.html.