Earlier this week, the U.S. FDA approved Amneal Pharmaceuticals' novel oral formulation of carbidopa/levodopa, branded Crexont, for the treatment of Parkinson's disease.
Crexont, which combines both immediate-release granules and extended-release pellets, provides a longer duration of 'good on' time with less frequent dosing compared to existing immediate-release treatments. Additionally, according to Amneal, existing oral treatments are short-acting, and patients can experience more motor fluctuations.
This was NJ-based Amneal's second attempt to win FDA approval for Crexont, with the agency handing the drugmaker a CRL last July. The letter indicated that while the safety of levodopa was established, it was not adequately established for the other ingredient, carbidopa. The FDA had requested additional information.
Back in 2015, Impax Pharmaceuticals won approval for its carbidopa and levodopa combo extended release capsules for Parkinson's motor symptoms, branded Rytary. Crexont relies on a different formulation and dosage strength.
Amneal expects to make Crexont available to patients in the U.S. this September.
