Continuous Parkinson’s Disease Therapy Wins FDA Nod

The FDA approved a subcutaneous 24-hour continuous infusion of foscarbidopa and foslevodopa (Vyalev) for advanced Parkinson’s disease, AbbVie announced Thursday.

Foscarbidopa and foslevodopa are pro-drugs for carbidopa and levodopa, which are standard-of-care Parkinson’s treatments. The new treatment, formerly know as ABBV-951, is the first subcutaneous 24-hour-a-day infusion of a levodopa-based therapy to treat motor fluctuations in advanced Parkinson’s, AbbVie said.

“For too long, the Parkinson’s community has had limited treatment options for advanced disease,” Robert Hauser, MD, MBA, of the University of South Florida in Tampa, said in an AbbVie news release.

“Due to the progressive nature of the disease, oral medications are eventually no longer as effective at motor symptom control and surgical treatment may be required,” Hauser continued. “This new, non-surgical regimen provides continuous delivery of levodopa morning, day, and night.”

The FDA’s decision was supported by a 12-week pivotal trial that evaluated continuous subcutaneous infusion versus oral immediate-release carbidopa and levodopa in people with advanced Parkinson’s disease.

The phase III trial showed that the foslevodopa-foscarbidopa infusion led to increased “on” time without troublesome dyskinesia (2.72 vs 0.97 hours, P=0.0083) and decreased “off” time (−2.75 vs −0.96 hours, P=0.0054) compared with oral treatment. (“On” time refers to periods of time when patients have optimal motor symptom control; “off” time is when symptoms return.)

Most adverse events in the trial were non-serious and mild or moderate. The most common adverse reactions with an incidence of at least 10% that occurred more frequently than with oral carbidopa-levodopa were infusion or catheter site events, hallucinations, and dyskinesia.

The approved dosage is 120 mg foscarbidopa and 2,400 mg foslevodopa per 10 mL. The drug carries warnings for sleepiness, hallucinations, impulse control behaviors, and dyskinesia. It is contraindicated in patients using a nonselective monoamine oxidase (MAO) inhibitor.

Foslevodopa-foscarbidopa is approved to treat Parkinson’s disease in other countries (it’s sold as Produodopa in the European Union), but AbbVie encountered a few stumbling blocks on its road to FDA approval, including questions from the agency about the drug’s subcutaneous pump device.

AbbVie also sells a continuous-delivery system for Parkinson’s branded as Duopa that pumps a levodopa-carbidopa gel directly into the intestinal tract for 16 hours a day. The FDA recently rejected ND0612, a 24-hour-a-day liquid levodopa and carbidopa infusion from the Mitsubishi Tanabe Pharma subsidiary NeuroDerm.

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