AbbVie Submits NDA for Parkinson’s Disease

AbbVie has submitted a new drug application (NDA) to the FDA for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in patients with advanced Parkinson’s disease (PD).

ABBV-951 is a combination of foscarbidopa and foslevodopa, which are prodrugs of carbidopa and levodopa, which are common therapies used in the treatment of Parkinson’s disease. The new therapy is designed to provide 24-hour, continuous subcutaneous delivery of oral immediate-release carbidopa/levodopa.

The submission is based on results from a phase 3 clinical trial demonstrating statistically significant improvement in “on” time without troublesome dyskinesia, or involuntary movements of the face, arms or legs, compared with oral immediate-release carbidopa/levodopa (CD/LD).

Compared with oral carbidopa/levodopa, ABBV-951 offers the potential for improvement in motor fluctuations in patients with advanced Parkinson’s disease, a progressive and chronic neurological disorder resulting from the loss of dopamine-producing brain cells, which primarily manifests with tremor, muscle rigidity, slowness of movement and difficulty with balance. In PD, patients and their healthcare providers share the same goal: to extend the amount of “on” time, referring to the period when symptoms are well-controlled without dyskinesia.

The phase 3 trial enrolled about 130 adult participants with Parkinson’s disease, whose motor symptoms were no longer adequately controlled by their current medications. The majority of adverse events were non-serious and mild or moderate in severity in the ABBV-951 group.

“Patients need more therapeutic options to control their symptoms and troublesome dyskinesia for this debilitating disease,” Jason Aldred, M.D., of Selkirk Neurology, clinical associate professor at the University of Washington, clinical assistant professor at Washington State University Elson S. Floyd College of Medicine, and a principal investigator of the study, said in a press release when initial results from this trial were announced in October 2021. "These data are promising and demonstrate positive results on a key endpoint used to assess efficacy of treatments for patients with advanced Parkinson’s.”