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FDA Approval for New Drugs

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.

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