AbbVie Submits New Drug Application to FDA for ABBV-951, a Novel Continuous Subcutaneous Therapy for Advanced Parkinson’s Disease

On May 21, AbbVie announced that it had submitted a New Drug Application (NDA) to the U.S. FDA for its investigational therapy ABBV-951 (foslevodopa/foscarbidopa) for the treatment of motor symptom fluctuations in patients with advanced Parkinson's disease. The press release noted that, if approved, ABBV-951 would provide patients with the first treatment option involving continuous subcutaneous delivery of levodopa/carbidopa prodrugs.

Parkinson's disease is a progressive neurodegenerative disorder caused by the gradual loss of brain cells that produce the neurotransmitter dopamine. The decline in dopamine levels in the brain leads to a wide range of motor and non-motor symptoms. Since the 1970s, the primary treatment for patients has been levodopa. However, over time, levodopa may cause involuntary, uncontrollable movements, known as dyskinesia.

In advanced patients, oral levodopa faces multiple challenges, such as the decline in gastrointestinal function leading to the drug not being absorbed into the body in a timely manner. Moreover, oral medications cannot maintain a stable level of drug concentration in the patient's body, which also results in the worsening of motor impairments.

ABBV-951 is a prodrug of levodopa and carbidopa. They are highly water-soluble and can be administered through continuous subcutaneous infusion via a pump connected to the subcutaneous tissue, thereby maintaining stable drug concentrations in the body.

Image Source: AbbVie Official Website

This NDA is primarily based on the results of the randomized, double-blind, active-controlled Phase 3 clinical trial M15-736. The trial results showed that ABBV-951 was more effective than oral immediate-release levodopa/carbidopa in controlling motor symptom fluctuations in patients with advanced Parkinson's disease.

"Advanced Parkinson's disease presents endless challenges and uncertainties for patients and caregivers worldwide," said Dr. Thomas Hudson, Chief Scientific Officer and Senior Vice President of R&D at AbbVie. "We are committed to addressing unmet patient needs, and new treatment approaches that enable continuous 24-hour dosing make better symptom control possible."

References:

[1] AbbVie Submits New Drug Application to U.S. FDA for Investigational ABBV-951 (Foscarbidopa/Foslevodopa) for the Treatment of Advanced Parkinson's Disease. Retrieved May 20, 2022, from https://news.abbvie.com/news/press-releases/abbvie-submits-new-drug-application-to-us-fda-for-investigational-abbv-951-foscarbidopafoslevodopa-for-treatment-advanced-parkinsons-disease.htm

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