Amneal Announces Positive Interim Phase 4 ELEVATE-PD Results With CREXONT® for Parkinson's Disease

• 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 (≥3%) were nausea (5.5%), falls (3.6%), dizziness (3.6%), and urinary tract infection (3.6%).

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:

1. Phase 4 ELEVATE-PD study (NCT06765668).
2. CREXONT package insert. Bridgewater, NJ: Amneal Pharmaceuticals LLC; 2024.
3. Hauser RA, et al. JAMA Neurol. 2023;80(10):1062-1069.
4. Modi NB, et al. Clin Neuropharmacol. 2019;42(1):4-8.
5. Dorsey ER et al. JAMA Neurol. 2018;75(1):9-10.
6. Marras et al. NPJ Parkinson's Dis. 2018;4:21.
7. NINDS. Parkinson's disease: challenges, progress, and promise. Reviewed August 2019.
8. Data Monitor: Gibrat et al., 2009; Goldenberg, 2008; Muangpaisan et al., 2009; Pringsheim et al., 2014.
9. John Hopkins Medicine. Young-Onset Parkinson's disease.
   
   

* Based on the time that LD plasma levers were maintained above 50% of C_max³

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