Amneal Reports P-III Study Results of IPX203 for the Treatment of Parkinson’s Disease
- The company published the 20wk. P-III (RISE-PD) clinical study results in the JAMA Neurology evaluating IPX203 vs optimized immediate-release carbidopa/levodopa (IR CD/LD) in a ratio (1:1) in patients with Parkinson’s disease who have motor fluctuations at 105 clinical sites in the US and EU countries, incl. Czechia, France, Germany, Italy, Poland, Spain and the UK
- The study met its 1EPs & 2EPs i.e., the therapy showed a significant improvement of 0.53hrs. in daily “Good On” time over-optimized IR CD/LD, with fewer daily doses when dosed a mean of 3 times per day with IPX203 vs 5 times per day
- The results also showed that “good” on-time per dose increased by nearly 2hrs. with IPX203 & was found to be well tolerated. IPX203 is a novel, oral formulation of CD/LD extended-release capsules
Ref: Businesswire | Image: Amneal
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