AbbVie has received approval for its subcutaneous, 24-hour infusion of of levodopa-based therapy, Vyalev, from the FDA.
The treatment is suitable for adults with advanced Parkinson's disease, and broadens treatment options for this patient population.
FDA approval was granted following the results of the Phase III clinical study that evaluated Vyalev's efficacy in comparison to oral immediate release carbidopa/levodopa.
From the study, it was determined that Vyalev demonstrated superior improvements in motor fluctuations, while increasing the time patients experience optimal motor symptom control.
Parkinson's disease is a progressive and chronic movement disorder that results in tremor, muscle rigidity, slowness of movement and difficulty with balance.
Robert A. Hauser, M.D., MBA, Professor of Neurology and Director of the Parkinson's and Movement Disorder Center at the University of South Florida, commented: "For too long, the Parkinson's community has had limited treatment options for advanced disease."
"Because of the progressive nature of the disease, oral medications are eventually no longer as effective at motor symptom control and surgical treatment may be required. This new, non-surgical regimen provides continuous delivery of levodopa morning, day and night."
Executive VP and CSO of AbbVie, Roopal Thakkar, added: "People living with advanced Parkinson's disease experience daily challenges as a result of uncertainty in managing motor fluctuations, especially as their disease progresses,"
"We are proud to bring this innovation to patients who may benefit from motor symptom control through continuous 24-hour administration of VYALEV."
