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Amneal Pharma announces positive topline results from pivotal phase III RISE-PD clinical trial of IPX 203 in patients with Parkinson's disease who experience motor fluctuations.

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Published:28th Aug 2021
Amneal Pharmaceuticals, Inc. announced positive topline results from the pivotal Phase III RISE-PD clinical trial that evaluated the novel formulation, IPX 203, in patients with Parkinson’s disease (PD) who have motor fluctuations.

The trial met its primary endpoint, demonstrating superior “Good On” time from baseline in hours per day at the end of the 13-week double-blind treatment period with IPX 203 CD/LD extended-release capsules compared with immediate-release CD/LD. Based on these topline results plus other supportive data, Amneal plans to submit a New Drug Application (NDA) for IPX 203 with the FDA in mid-2022.he FDA) in mid-2022.

Phase III topline results showed the study was successful in demonstrating statistically significant improvement in efficacy for IPX 203 compared to immediate-release CD/LD, even when IPX 203 was dosed on average 3 times per day and immediate-release CD/LD was dosed on average 5 times per day. IPX 203 treatment resulted in 0.53 more hours of “Good On” time than immediate-release CD/LD (p=0.0194), when comparing change from baseline (Week 7) in both study arms.

The secondary endpoint for change from baseline in “Off” time showed IPX 203 resulted in significantly less “Off” time compared with immediate-release CD/LD (-0.48 hr, p=0.0252). In addition, analysis of the secondary endpoint for Patients' Global Impression of Change (PGI-C) scores showed 29.7% of patients treated with IPX 203 were “much improved” or “very much improved” compared with 18.8% of patients treated with immediate-release CD/LD (p=0.0015). IPX-203 change from baseline scores for Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III or sum of MDS-UPDRS Part II and III were similar to those of immediate-release CD/LD.

A post-hoc analysis of Least Squares Mean difference at Week 20 (EOS/ET) showed IPX 203 increased “Good On” time by 1.55 hours per dose compared with immediate-release CD/LD (p<0.0001).></0.0001).>

In the randomized patient population, eight (3.1%) subjects reported serious adverse events (SAEs) in the IPX-203 study arm and four (1.6%) subjects reported SAEs in the immediate-release CD/LD arm. Treatment-emergent adverse events (TEAEs) were reported for both study arms (108 [42.2%] for IPX-203, 79 [31.6%] for immediate-release CD/LD). The most common AEs (greater than 3%) were nausea, dry mouth, urinary tract infection, and fall.

Condition: Parkinsons
Type: drug

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