Longer ‘On’ Time Seen With Infused ABBV-951 Than Oral Levodopa in Trial
ABBV-951, an under-the-skin formulation of levodopa/carbidopa, outperformed the standard oral therapy at controlling Parkinson’s symptoms in advanced disease patients in a Phase 3 clinical trial, top-line results show.
“These data are promising and demonstrate positive results on a key endpoint used to assess efficacy of treatments for patients with advanced Parkinson’s,” Jason Aldred, MD, a professor at the University of Washington and principal trial investigator, said in a press release.
Trial findings will help to support requests for regulatory approval, AbbVie, ABBV-951’s developer, said in the release.
Parkinson’s is caused by the death or dysfunction of dopamine-making brain nerve cells. Levodopa/carbidopa is a standard treatment, which basically works by giving the brain more raw material with which to make dopamine.
Although levodopa/carbidopa therapy can effectively ease Parkinson’s symptoms, it has several well-known drawbacks: patients will experience “on” time, when symptoms are being effectively controlled, but also “off” time when they aren’t. Long-term use of these therapies also often leads to the development of dyskinesia (uncontrolled movements).
Levodopa/carbidopa therapy is generally given orally. ABBV-951 is a formulation of this therapy designed for continuous subcutaneous (under-the-skin) infusion.
AbbVie sponsored a Phase 3 clinical trial (NCT04380142) that enrolled 174 people with advanced Parkinson’s at 80 sites around the world. Participants were treated either with ABBV-951 or with oral levodopa/carbidopa; each received a placebo version of whichever treatment they didn’t get.
The study’s main goal was the effect of ABBV-951 treatment on “on” and “off” time, as assessed via participant diaries.
After 12 weeks of treatment, results showed a significantly greater increase in “on” time without troublesome dyskinesia among patients given ABBV-951 compared with those on oral treatment (2.72 vs. 0.97 hours). Consistently, the decrease in “off” time was also higher in the ABBV-951 group relative to the oral therapy group (2.75 vs. 0.96 hours).
The improvements in “on” time “were observed as early as the first week and persisted throughout the 12 weeks,” AbbVie reported.
Most of the adverse events (side effects) in patients treated with ABBV-951 were considered mild or moderate in intensity. Adverse events led 21.6% of people in the ABBV-951 group to discontinue treatment, compared with 1.5% of those on oral treatment.
Serious adverse events were reported in 8% of patients on ABBV-951, and 6% of those on oral therapy.
The most common adverse events among participants treated with ABBV-951 included infusion site reactions (e.g., redness, pain, swelling), dyskinesia, hallucinations, falls and balance problems, swelling, and constipation. Infusion site reactions and psychosis were more common in the ABBV-951 group, while falls and associated injuries were more common among patients given oral treatment.
“We’re committed to addressing the continued needs of patients and are encouraged by these results that highlight a potential alternative treatment option for those affected by advanced Parkinson’s disease,” said Michael Severino, MD, the company’s vice chairman and president.