AbbVie Submits FDA Application For Continuous, 24-Hour Infusion Therapy For Parkinson's - AbbVie (NYSE:ABBV)

AbbVie Inc ABBV submitted its FDA marketing application for ABBV-951, a solution of levodopa and carbidopa prodrugs being evaluated in advanced Parkinson’s patients who don’t respond well to oral therapy.
AbbVie’s theory here revolves around using a continuous, 24-hour infusion of its therapy. The levodopa and carbidopa prodrugs are delivered in small doses subcutaneously through a pump and are designed to activate once they enter the bloodstream.
In its pivotal Phase 3 study, AbbVie assessed when the symptoms were well-controlled and when not. The company described these as “On” and “Off” times.
The average increase was 2.72 hours of “On” time for patients taking ABBV-951 and 0.97 among those on the standard of care.
Additionally, decreases of “Off” time came in at 2.75 hours in the treatment arm and 0.96 hours in the standard of care group.
Both differences were statistically significant.
AbbVie noted that the adverse event profile came in largely mild-to-moderate. Most side effects had to do with the infusion site, including pain, skin reddening, inflammation, and bruising.
Price Action: ABBV shares are down 1.81% at $148.98 during the market session on the last check Friday.