AbbVie submits NDA for advanced Parkinson’s treatment

Biopharmaceutical company AbbVie has submitted a new drug application to the FDA for ABBV-951, a 24-hour subcutaneous treatment for motor fluctuations in patients with advanced Parkinson's disease.

Per a company press release, the submission is based on positive results from a phase 3, head-to-head, randomized, controlled clinical trial in which approximately 130 adult participants with PD, whose motor symptoms were no longer adequately controlled by their current medications, were enrolled across 80 sites in the U.S. and Australia.

During the 12-week trial, participants received either ABBV-951 (foscarbidopa/foslevodopa, AbbVie) solution as continuous subcutaneous delivery plus oral placebo capsules for carbidopa/levodopa or oral, immediate-release carbidopa/levodopa plus continuous subcutaneous delivery of placebo solution.

According to the release, foscarbidopa/foslevodopa demonstrated statistically significant improvement in "on" time without troublesome dyskinesia compared with oral carbidopa/levodopa.

“Advanced Parkinson's disease causes unrelenting challenges and uncertainty for patients and caregivers worldwide,” Thomas Hudson, MD, senior vice president of research and development and chief scientific officer at AbbVie, said in the release. “We are committed to addressing the unmet needs of those affected by the disease and recognize the urgency for a new treatment that can enable better symptom control through the continuous 24-hour administration of medication.”