Subcutaneous Formulation of Carbidopa/Levodopa for Parkinson Disease Submitted to FDA for Approval

A new drug application was submitted to the FDA for a new formulation of of foscarbidopa/foslevodopa (CD/LD) (ABBV-951; Abbvie, Chicago, IL) delivered subcutaneously for treatment of Parkinson disease (PD). In a clinical trial (NCT04380142), the subcutaneous formulation of CD/LD provided significant improvement from baseline in ON time without troublesome dyskinesia compared with oral immediate-release CD/LD.

When compared with the oral CD/LD, the 24-hour subcutaneous CD/LD delivery shows more improvement in motor fluctuations. At 12 weeks of treatment, improvements seen as early as 1 week, the increase in "On" time was 2.72 hours  for subcutaneous formulation of LD/CD vs 0.97 hours for oral LD/CD (P= .0083). 

“Advanced Parkinson’s disease causes unrelenting challenges and uncertainty for patients and caregivers worldwide,” said Thomas Hudson, MD, senior vice president, research and development, chief scientific officer, AbbVie. “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.” 
 
"ON" time without dyskinesia plus "ON" time with nontroublesome dyskinesia were based on the Parkinson Disease (PD) Diary (normalized to a 16-hour waking day averaged over 3 consecutive days). Baseline ON time was defined as the average of normalized "ON" time without troublesome dyskinesia collected over the 3 PD Diary days before randomization.

Participants (n=130) had PD with motor symptoms no longer controlled by their current medications. The study was a phase 3 a randomized, double-dummy, double-blind active-controlled study to evaluate superior efficacy in CD/LD treatment.

Among those treated with oral CD/LD, there was 1 treatment-emergent fatality. The most common adverse events that occurred in 10% of more of those treated with subcutaneous CD/LD  were erythema, pain, cellulitis, and edema, and dyskinesia.