6 4 (CR) and immediate-release (IR) tablet formula- tions throughout the day failing to adequately resolve off periods Patients should not be prescribed the extended release capsules if they are currently taking a nonselective mono- amine oxidase (MAO) inhibitor (e.g., phenelzine and tranylcypromine) or have recently (within 14 days) taken a nonselective MAO inhibitor Inclusion. The formulary language also cautions against contraindication, intoler- ance or inadequate therapeutic response to at least one agent from two of the following classes: dopamine ago- nist, catechol-O methyl transferase [COMT] inhibitor and monoamine oxidase type B [MAO B] inhibitor. Late last year, Amneal Pharmaceuticals Inc. announced new positive interim results for Crexont from its ongoing Phase 4 ELEVATE-PD study, which was presented at the Parkinson’s Study Group (PSG) Annual Meeting. The first 55 patients evaluated after 6 weeks of treat- ment demonstrated substantial clinical benefit after switching to the extended-release capsules, including sig- nificant increases in daily “Good On” time, reductions in “Off” time, improved motor symptom control, and con- sistent gains in “Good On” time per dose. That was the case, according to the results, whether patients switched from immediate-release carbidopa/levodopa (IR CD/LD), IR CD/LD with a COMT inhibitor, or Rytary (carbidopa and levodopa) extended-release capsules. Crexont uses a novel mucoadhesive polymer designed to optimize levodopa delivery and absorption. Studies suggest it provides the longest-lasting levodopa plasma levels of any oral CD/LD therapy available today. “These early results confirm what clinicians are already seeing every day—patients on Crexont feel better, stay ‘On’ longer, and experience more predictable con- trol of their symptoms,” Stuart Isaacson, MD, director of the Parkinson’s Disease and Movement Disorders Center in Boca Raton, FL, said in an Amneal press release. “For Parkinson’s patients and the clinicians who care for them, this represents a real-world step forward in how we can manage the disease day-to-day.” Interim results from the ELEVATE-PD study found that, after 6 weeks on Crexont, the first 55 patients, with a mean age of 66.4, had 3.13 hours of additional “Good On” hours when switching from IR CD-LD, (n=36), +2.31 hours from IR CD-LD+COMT inhibitor (n=6) and +1.80 hours from Rytary® (n=11). Off times reduced by 2.83 hours (IR CD/LD), 2.36 hours (IR CD/LD + COMT) and 2.57 hours (Rytary) The increase in “Good On” time per dose was +1.86, +0.77 and +0.79 hours, respectively. The Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) improvements, total score, were -14.2, -4.1, and -13.9 points, respectively. Treatment-emergent adverse events (TEAEs) were generally mild to moderate and consistent with prior therapy, according to a press release. ELEVATE-PD is an open-label, Phase 4, multicenter clinical study designed to evaluate the real-world efficacy and safety of switching to Crexont in adults with moder- ately severe Parkinson’s disease experiencing motor com- plications such as off periods and dyskinesia despite being on a stable dose of oral levodopa-based regimen. The trial plans to enroll approximately 220 participants and will follow them for 13-14 months, consisting of 10 clini- cal visits. The drug, which originally was designated as IPX203, gained approval based on the RISE-PD Randomized Clinical Trial, which was published in JAMA Neurology in 2023.4 The authors concluded, “In this phase 3 study, IPX203 resulted in significantly increased daily good on-time, even as IPX203 was administered 3 times per day and IR CD-LD was administered 5 times per day. These results suggest that IPX203 may be useful in patients with motor fluctuations to provide more sustained benefit throughout the day. IPX203 dose conversion based on the most frequent unit dose of IR CD-LD may represent a relatively easy dose-conversion strategy for use in clini- cal practice.” 1Ostrem JL, Luo P, Weaver FM, Follett K, et. Al. ; CSP 468F Study Group. 10-year clinical outcomes of subthalamic nucleus versus pallidal deep brain stimulation for Parkinson’s disease: VA/NINDS CSP #468F. Front Neurol. 2026 Jan 16;16:1728999. doi: 10.3389/fneur.2025.1728999. PMID: 41626017; PMCID: PMC12856926. 2Nyholm D, Odin P, Johansson A, Chatamra K, Locke C, Dutta S, Othman AA. Pharmacokinetics of levodopa, carbidopa, and 3-O- methyldopa following 16-hour jejunal infusion of levodopa-carbidopa intestinal gel in advanced Parkinson’s disease patients. AAPS J. 2013 Apr;15(2):316-23. doi: 10.1208/s12248-012-9439-1. Epub 2012 Dec 11. PMID: 23229334; PMCID: PMC3675750. 3Jimenez-Shahed J, Malaty IA, Soileau M, Yan CH, Kandukuri L, Schinkel J, Teigland C, Shah MB, Kukreja P, Hambrick A, Fernandez HH. Association of patient characteristics, social drivers of health, and geographic location on access to device-aided therapies among Medicare beneficiaries with advanced Parkinson’s disease. Parkinsonism Relat Disord. 2025 Apr;133:107322. doi: 10.1016/j.parkreldis.2025.107322. Epub 2025 Feb 6. PMID: 39965428. 4Hauser RA, Espay AJ, Ellenbogen AL, et al. IPX203 vs Immediate- Release Carbidopa-Levodopa for the Treatment of Motor Fluctuations in Parkinson Disease: The RISE-PD Randomized Clinical Trial. JAMA Neurol. 2023;80(10):1062–1069. doi:10.1001/jamaneurol.2023.2679
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