Amneal Announces Positive Interim Phase 4 ELEVATE-PD Results With CREXONT® for Parkinson’s Disease
Rhea-AI Summary
Amneal (NASDAQ: AMRX) reported positive interim Phase 4 ELEVATE-PD results for CREXONT (carbidopa/levodopa extended-release) from the first 55 patients after six weeks.
Key metrics: Good On time increased +3.13 hours (from IR CD/LD), +2.31 hours (IR CD/LD+COMT), +1.80 hours (Rytary); Off time reduced −2.83, −2.36, and −2.57 hours respectively; MDS-UPDRS total score improved −14.2, −4.1, and −13.9 points respectively. Good On time per dose also rose across cohorts.
Safety: TEAEs were generally mild-to-moderate; common events ≥3%: nausea 5.5%, falls 3.6%, dizziness 3.6%, UTI 3.6%. Longer-term and patient-reported outcomes will be presented in 2026.
Positive
- Daily Good On time increased up to +3.13 hours (IR CD/LD cohort)
- Daily Off time reduced by up to −2.83 hours
- MDS‑UPDRS total score improved by −14.2 points in one cohort
- Consistent Good On time gain per dose across prior-therapy cohorts
Negative
- Interim dataset limited to 55 patients and a six-week follow-up
- One cohort showed smaller MDS‑UPDRS improvement of −4.1 points
- Common TEAEs included nausea 5.5% and falls 3.6%
- CREXONT has a safety warning for nonselective MAO inhibitor coadministration and somnolence risk
Key Figures
Market Reality Check
Peers on Argus 1 Up
Peers in Specialty & Generic pharma showed mixed, mostly modest moves (e.g., BHC up 4.38%, PRGO down 3.64%), and only one momentum‑screen peer (ALVO) appeared, suggesting today’s AMRX setup was more stock‑specific than sector‑driven.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 02 | Investor conferences | Neutral | -2.5% | Announcement of participation in upcoming healthcare investor conferences. |
| Dec 02 | FDA approval | Positive | -2.5% | U.S. FDA approval for albuterol sulfate inhalation aerosol generic to PROAIR HFA. |
| Dec 01 | FDA approval | Positive | -2.5% | U.S. FDA approval of cyclosporine ophthalmic emulsion 0.05% generic to RESTASIS. |
| Nov 13 | FDA approval | Positive | +1.0% | First generic approval for iohexol injection across multiple imaging indications. |
| Oct 30 | Quarterly earnings | Positive | -4.1% | Q3 2025 revenue growth and raised full‑year guidance across key metrics. |
Recent positive catalysts (FDA approvals, earnings, conferences) often saw negative next‑day moves, indicating a tendency for the stock to sell off on good news.
Over the last several months, Amneal has delivered multiple positive milestones, including three U.S. FDA approvals in November–December 2025, a Q3 2025 earnings report with net revenue of $785 million, and participation in major investor conferences. Despite these constructive updates, four of the last five news events saw negative 24h price reactions, with only the iohexol approval on Nov 13 posting a modest gain. Today’s positive Phase 4 CREXONT data arrives against that backdrop of frequent good news but mixed price responses.
Market Pulse Summary
This announcement highlights positive interim Phase 4 ELEVATE-PD data for CREXONT, with multi-hour improvements in “Good On” time and meaningful MDS-UPDRS score reductions across switch groups. Prior CREXONT and biosimilar trials also showed favorable outcomes, reinforcing Amneal’s clinical execution. Investors may focus on longer-term outcomes expected in 2026, real-world durability of benefit, and ongoing safety findings, while considering how these results complement the company’s recent run of regulatory approvals and revenue growth.
AI-generated analysis. Not financial advice.
- Interim data show substantial improvements in “Good On” time compared to other oral CD/LD therapies
- CREXONT delivered substantial “Off” time reductions, improved motor symptom control and provided a longer duration of benefit with each dose
- Findings highlight CREXONT as a key therapy in a category with limited innovation
- ELEVATE-PD study is ongoing with longer-term data expected in 2026
BRIDGEWATER, N.J., Dec. 05, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) today announced new positive interim results from its ongoing Phase 4 ELEVATE-PD study, presented at the Parkinson’s Study Group (PSG) Annual Meeting.
The first 55 patients evaluated after six weeks of treatment demonstrated substantial clinical benefit after switching to CREXONT® (carbidopa and levodopa) extended-release capsules, including significant increases in daily “Good On” time, reductions in “Off” time, improved motor symptom control, and consistent gains in “Good On” time per dose—regardless of 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.1
CREXONT is Amneal’s next-generation extended-release CD/LD formulation that uses a novel mucoadhesive polymer designed to optimize levodopa delivery and absorption, providing the longest-lasting levodopa plasma levels of any oral CD/LD therapy available today.2-4*
“These early results confirm what clinicians are already seeing every day—patients on CREXONT feel better, stay ‘On’ longer, and experience more predictable control of their symptoms,” said Stuart Isaacson, MD, Director of the Parkinson’s Disease and Movement Disorders Center in Boca Raton, FL. “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.”
“The ELEVATE-PD study interim results showcase CREXONT’s differentiated clinical performance and substantial real-world benefit,” said Dr. Avinash Desai, Senior Vice President and Chief Scientific Officer, Specialty, at Amneal Pharmaceuticals. “These interim results reinforce what patients and providers are already experiencing: CREXONT is measurably improving daily function and elevating care for people living with Parkinson’s. In a field with limited innovation for decades, CREXONT is perhaps the most significant therapy advancement in decades.”
Key Interim Findings (First 55 Patients, Six-Week Analysis)
Among patients switching to CREXONT (mean age 66.4 ± 8.95 years)1:
Increase in Daily “Good On” Time
- +3.13 hours when switching from IR CD-LD (n=36)
- +2.31 hours from IR CD-LD+COMT inhibitor (n=6)
- +1.80 hours from Rytary® (n=11)
Reduction in Daily “Off” time:
- –2.83 hours (IR CD/LD)
- –2.36 hours (IR CD/LD + COMT)
- –2.57 hours (Rytary)
Increase in “Good On” Time per Dose:
- +1.86, +0.77, and +0.79 hours, respectively
MDS-UPDRS Improvements (Total Score):
- –14.2, –4.1, and –13.9 points, respectively
Safety: In the study, treatment-emergent adverse events (TEAEs) were generally mild to moderate and consistent with prior therapy. CREXONT should not be taken with antidepressant medications known as nonselective monoamine oxidase (MAO) inhibitors. CREXONT may cause falling asleep during activities of daily living, somnolence, or dizziness. The most common (≥
Amneal will present longer-term outcomes and patient-reported results in 2026 as part of the ongoing, rolling ELEVATE-PD program, further strengthening the evidence for CREXONT’s impact on motor symptom control and functional independence.
Poster #92 was presented today at the PSG Annual Meeting in San Diego.
About CREXONT®
CREXONT is an innovative formulation consisting of immediate-release granules with carbidopa and levodopa for rapid onset of action and extended-release pellets containing a mucoadhesive polymer technology with a levodopa core for long-lasting efficacy. CREXONT formulation and dosage strengths are different from RYTARY® (carbidopa and levodopa) extended-release capsules approved by the U.S. FDA in 2015. Learn more about CREXONT at crexont.com.
About ELEVATE-PD
ELEVATE-PD is an open-label, Phase 4, multi-center clinical study designed to evaluate the real-world efficacy and safety of switching to CREXONT in adults with moderately severe Parkinson’s disease experiencing motor complications 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 clinical visits.
INDICATION
CREXONT® (carbidopa and levodopa) extended-release capsules for oral use is indicated for the treatment of Parkinson’s disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication or manganese intoxication in adults.
IMPORTANT SAFETY INFORMATION
- Do not take CREXONT with antidepressant medications known as nonselective monoamine oxidase (MAO) inhibitors.
- Do not take CREXONT with other carbidopa-levodopa preparations without consulting your healthcare provider.
- CREXONT may cause falling asleep during activities of daily living, somnolence, or dizziness. Avoid activities that require alertness such as driving and operating machinery, until you know how CREXONT affects you.
- The most common side effects that may occur with CREXONT are nausea and anxiety.
- Avoid sudden discontinuation or rapid dose reduction with CREXONT. If you are discontinuing CREXONT, work with your healthcare provider to taper the dose over time to reduce the risk of fever or confusion.
- You may take CREXONT with or without food; but taking it with food may decrease or delay its effect. Consider taking the first dose of the day about 1 to 2 hours before eating.
- Swallow CREXONT whole. Do not chew, divide, or crush the capsules.
- Do not take CREXONT with alcohol.
Tell your healthcare provider if you:
- Have any heart conditions, especially if you have had a heart attack or irregular heartbeats.
- Experience hallucinations or abnormal thoughts and behaviors.
- Have an inability to control urges to gamble, have increased sexual urges, or experience other intense urges.
- Have thoughts of suicide or have attempted suicide.
- Have abnormal involuntary movements that appear or get worse during treatment.
- Have ever had a peptic ulcer or glaucoma.
- Become or intend to become pregnant. Based on animal data, CREXONT may cause fetal harm.
- Are breastfeeding during therapy.
- Have side effects; your doctor can adjust your dose.
To report SUSPECTED ADVERSE REACTIONS, contact Amneal Specialty, a division of Amneal Pharmaceuticals LLC at 1-877-835-5472 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please read the full Prescribing Information. For more information talk to your healthcare provider.
About Parkinson’s Disease
Parkinson’s disease (PD) has become the fastest growing neurological disorder worldwide, with approximately 1 million people diagnosed in the U.S.3,4 It is a progressive disorder of the central nervous system (CNS) that affects dopamine-producing neurons in the brain that affect movement. PD is characterized by slowness of movement, stiffness, resting tremor and impaired balance.5 While PD is not considered a fatal disease, it is associated with significant morbidity and disability.6 The average age at diagnosis for people with PD is 60; as people live longer, the number of people living with PD is predicted to grow significantly over the coming decades.3,7
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 290 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com and follow us on LinkedIn.
Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.
References:
- Phase 4 ELEVATE-PD study (NCT06765668).
- CREXONT package insert. Bridgewater, NJ: Amneal Pharmaceuticals LLC; 2024.
- Hauser RA, et al. JAMA Neurol. 2023;80(10):1062-1069.
- Modi NB, et al. Clin Neuropharmacol. 2019;42(1):4-8.
- Dorsey ER et al. JAMA Neurol. 2018;75(1):9-10.
- Marras et al. NPJ Parkinson’s Dis. 2018;4:21.
- NINDS. Parkinson’s disease: challenges, progress, and promise. Reviewed August 2019.
- Data Monitor: Gibrat et al., 2009; Goldenberg, 2008; Muangpaisan et al., 2009; Pringsheim et al., 2014.
- John Hopkins Medicine. Young-Onset Parkinson’s disease.
* Based on the time that LD plasma levers were maintained above
Investor Contact
Anthony DiMeo
VP, Investor Relations
anthony.dimeo@amneal.com
Media Contact
Brandon Skop
Sr. Director, Corporate Communications
brandon.skop@amneal.com
FAQ
What did Amneal announce about CREXONT in the ELEVATE-PD interim results on December 5, 2025?
How much did Good On time increase for AMRX patients switching from IR CD/LD?
What safety events were reported in the ELEVATE-PD interim analysis for AMRX CREXONT?
When will Amneal present longer-term ELEVATE-PD results for AMRX CREXONT?
Does CREXONT interact with specific medications according to the December 5, 2025 release?
