US regulators issued a green light last week for a new Parkinson’s disease treatment designed to help better control motor fluctuations in patients with advanced disease.
The US Food and Drug Administration cleared AbbVie's orphan drug Duopa (carbidopa and levodopa), an enteral suspension administered via a small, portable infusion pump that delivers the active substances directly into the small intestine.
The drug is the first treatment to provide 16 hours’ continuous treatment with carbidopa and levodopa for motor fluctuations, and its route of administration bypasses the difficulties that oral dosing and unpredictable absorption can present in later stages of the illness.
According to AbbVie, clinical trials showed that patients taking Duopa experienced less “off-time”, or periods of poor mobility, slowness and stiffness, than those taking oral carbidopa-levodopa immediate release tablets.
It is estimated that 60,000 new cases of Parkinson's disease are reported each year in the US, adding to as many as 1 million people who currently have the disease, for which treatment options, particularly in the advanced stages, remain limited.
Impax’ Rytary - an extended-release form of carbidopa-levodopa - was also OK’d by the FDA this month as a treatment for Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism post carbon monoxide and/or manganese intoxication.