AbbVie Submitted NDA for Parkinson’s Disease Drug

AbbVie submitted a New Drug Application (NDA) to the FDA for its investigational drug, ABBV-951 (foscarbidopa/foslevodopa), for treatment of motor fluctuations in patients with advanced Parkinson’s disease.

ABBV-951 is a solution of carbidopa and levodopa prodrugs — compounds that are metabolized after administration into a pharmacologically active drug. Carbidopa and levodopa are normally used to treat symptoms of Parkinson’s disease. ABBV-951 is designed for continuous subcutaneous delivery.

The NDA is supported by results from a late stage study in 130 participants whose disease-related motor symptoms were no longer adequately controlled with their current medications. Patients who received ABBV-951 saw meaningful improvements in their “on” time without uncontrolled muscle movements.