FDA approves Rytary for Parkinsons-Impax Pharma

The FDA has approved Rytary (extended-release oral carbidopa-levodopa), from Impax Pharma, for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and / or manganese intoxication. Approval was based on two studies: In APEX-PD with 381 levodopa-naive patients, the study met its primary efficacy endpoint of mean change from baseline in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living) score and UPDRS Part III (motor skills) score for Rytary versus placebo at Week 30 (or early termination).

In ADVANCE-PD on 393 patients with advanced Parkinson's disease having "off" time, the results showed treatment with Rytary reduced the percentage of "off" time (36.9% to 23.8%) from baseline versus immediate-release carbidopa-levodopa (36.0% to 29.8%) during waking hours to end of study. Rytary also increased "on" time without troublesome dyskinesia during waking hours versus baseline to end of study by 1.8 hours. Less "off" time was primary related to more "on" time without troublesome dyskinesia. The most common adverse reactions with Rytary in the APEX-PD trial were nausea, dizziness, headache and insomnia. The most common adverse reactions in the ADVANCE-PD trial were nausea and headache.

Comment:There are a number of treatments available for Parkinson�s but levodopa-based drugs are still the most frequently used. In spite of controlled-release formulations of both Sinemet and Madopar being available, many patients still continue to suffer from levodopa response complications. Hence the planned role for Rytary.