FDA January Approvals Bring New Parkinson's Therapies to U.S. Market

FoxFeed Blog

Posted by  Kimberly Sawicki, January 26, 2015

This past month the U.S. Food and Drug Administration (FDA) approved two new formulations of traditional Parkinson’s therapy levodopa/carbidopa. Both therapies are designed to avoid “off” time in Parkinson’s — when symptoms return before another dose of medication is due.

MJFF-awardee Impax Pharmaceuticals announced the approval of RYTARY, an extended-release, oral capsule formulation of the drug. Phase III clinical trial participants experienced nearly an hour and a half less “off” time per day when taking the drug.

Less than a week later, the FDA approved AbbVie’s Duopa gel formulation of levodopa/carbidopa. The treatment, approved in Europe under the name Duodopa since 2004, is delivered directly into the small intestine via a small infusion pump and tube. The drug bypasses the stomach and thereby some of the absorption issues impacting oral medicine. Duopa requires patients wear a large external “box” in the belt region that may require maintenance.