Amneal Pharmaceuticals announced that the first 55 patients in its Phase 4 ELEVATE‑PD study of CREXONT, an extended‑release carbidopa/levodopa capsule, achieved clinically meaningful improvements after six weeks of treatment. The interim data, presented at the Parkinson’s Study Group Annual Meeting, show a 3.13‑hour increase in daily “Good On” time and a 2.83‑hour reduction in “Off” time versus immediate‑release carbidopa/levodopa, and a 2.36‑hour reduction versus the combination of immediate‑release carbidopa/levodopa plus a COMT inhibitor. Adverse events were low, with nausea, falls, dizziness and urinary tract infection occurring in fewer than 5.5% of patients.
CREXONT’s mucoadhesive polymer platform delivers a rapid onset through immediate‑release granules while maintaining prolonged levodopa exposure via extended‑release pellets. This dual‑release design gives patients a more predictable and longer‑lasting symptom control than existing extended‑release options such as RYTARY, which relies on a single release mechanism. The technology therefore positions CREXONT as a differentiated therapy in a crowded Parkinson’s market.
The drug received FDA approval in August 2024 and launched in September 2024. It is a key driver of Amneal’s Specialty segment, which grew 8% in revenue during Q3 2025. The segment’s performance was supported by strong demand for CREXONT and expanding insurance coverage, with more than 50% of covered lives enrolled by April 2025. The interim results reinforce the commercial momentum and support the company’s strategy to capture a larger share of the $1 billion‑plus U.S. Parkinson’s market.
The Phase 4 study will enroll approximately 220 participants and follow them for 13–14 months. Amneal plans to present longer‑term outcomes and patient‑reported results in 2026, which will provide a more comprehensive assessment of CREXONT’s efficacy and safety profile and inform its commercial launch strategy.
Senior Vice President and Chief Scientific Officer of Specialty, Dr. Avinash Desai, said the data confirm CREXONT’s “most significant therapy advancement in decades” for Parkinson’s disease, highlighting its differentiated clinical performance and real‑world benefit. Dr. Stuart Isaacson, Director of the Parkinson’s Disease and Movement Disorders Center, noted that patients on CREXONT “feel better, stay ‘On’ longer, and experience more predictable control of their symptoms.”
The positive interim results are expected to strengthen Amneal’s competitive position, potentially expanding its market share and accelerating revenue growth in the Specialty segment. The data also support the company’s ongoing efforts to broaden insurance coverage, which has already reached a majority of covered lives, and to position CREXONT as a preferred option for patients seeking more consistent symptom control.
In summary, the interim Phase 4 findings validate CREXONT’s clinical promise, reinforce Amneal’s strategic focus on specialty therapeutics, and set the stage for a robust commercial rollout in 2026.
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