Amneal Announces Full Study Population Interim Phase 4 ELEVATE-PD Results, Reinforcing Previously Reported Benefits of CREXONT in Parkinson's Disease

• Phase 4 ELEVATE-PD interim data from the entire study population (n=214) continue to show clinically meaningful, consistent benefits of CREXONT across all prior treatment groups
• Substantial increases in daily “Good On” time, reductions in “Off” time, and meaningful improvements in motor function were observed after switching to CREXONT^®
• Patients switching to CREXONT^® from RYTARY^® gained 3.03 hours of additional daily “Good On” time and nearly doubled the duration of continuous “Good On” intervals, enabling longer, uninterrupted periods of symptom control
  

BRIDGEWATER, N.J., June 05, 2026 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), today announced new positive interim results from its ongoing Phase 4 ELEVATE-PD study, which are being presented at the Advanced Therapeutics in Movement & Related Disorders^® (ATRMD) 2026 Congress on June 5, 2026.

The entire study population (n=214) evaluated after six weeks of treatment demonstrated substantial clinical benefit after switching to CREXONT^® (carbidopa and levodopa) extended-release capsules, regardless of whether patients switched from immediate-release carbidopa/levodopa (IR CD/LD), IR CD/LD plus a COMT inhibitor, or RYTARY^® (carbidopa and levodopa) extended-release capsules. These interim findings build on the established efficacy and safety profile of CREXONT demonstrated in the Phase 3 RISE-PD trial, and reflected in the FDA-approved prescribing information.

After patients switched from prior therapies, treatment with CREXONT delivered meaningful increases in “Good On” time, reductions in “Off” time, and improved motor symptom control. Patients switching from RYTARY achieved consistent gains in continuous “Good On” intervals, the length of uninterrupted time patients experience “Good On.”

The most common adverse events (≥3%) in the study were dizziness (8.2%), fall (6.9%), nausea (6.5%), dyskinesia (6.5%), hallucination (3.0%), and headache (3.0%). 

“The results from the entire study population highlight the consistency of CREXONT in delivering meaningful benefit to patients, regardless of the therapy they had been using,” said Stuart Isaacson, MD, a Study Investigator and Director of the Parkinson’s Disease and Movement Disorders Center in Boca Raton, FL. “This kind of reproducible, real-world signal is what gives us confidence as clinicians that patients will experience more “Good On” time and less interruptions to their daily lives.”

“Consistent with the previously reported results, the interim data from the entire study population of ELEVATE-PD underscores CREXONT ability to give patients more predictable symptoms control,” added Dr. Avinash Desai, Senior Vice President and Chief Scientific Officer, Specialty, at Amneal. “We believe these results further support CREXONT as a differentiated extended-release oral therapy, giving patients longer continuous “Good On” time per day.”

Overall Interim Findings (Entire Study Population, 214Patients; Six-Week Analysis)
All 214 patients who switched to CREXONT (mean age 67.1±9.07 years):

Increased Daily “Good On” Time:

• +3.33 hours when switching from IR CD/LD (n=156)
• +3.20 hours when switching from IR CD/LD + COMT inhibitor (n=17)
• +3.03 hours when switching from RYTARY (n=41)
  

Reduced Daily “Off” Time:

• –3.20 hours when switching from IR CD/LD
• –2.96 hours when switching from IR CD/LD + COMT inhibitor
• –2.4 hours when switching from RYTARY
  

Improved MDS-UPDRS Total Scores

• Improvements of –14.6, –9.9, and –10.0 points when switching from IR CD/LD, IR CD/LD + COMT inhibitor, and RYTARY, respectively — reductions of this magnitude reflect clinically meaningful gains in overall motor function
  

Subgroup Analysis: Additional Interim Findings in Patients Switching from RYTARY^®
Among the 41 patients switching from RYTARY, CREXONT delivered particularly notable gains in symptom control:

• Mean duration of continuous “Good On” intervals nearly doubled, increasing from 3.19 hours at baseline to 6.27 hours at Week 6, a 3.08-hour gain in uninterrupted symptom control
• Mean daily motor fluctuations were meaningfully reduced, decreasing from 5.28 at baseline to 2.98 at Week 6, a 2.26 (42.80%) reduction in the average number of daily motor fluctuations

Safety: In the study, treatment-emergent adverse events (TEAEs) were generally mild to moderate and consistent with prior therapy. The most common (≥3%) in the study were dizziness (8.2%), fall (6.9%), nausea (6.5%), dyskinesia (6.5%), hallucination (3.0%), and headache (3.0%). 

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. Treatment with carbidopa/levodopa, including CREXONT, may contribute to reduced vitamin B6 levels. Seizures associated with vitamin B6 deficiency have been reported. Evaluate vitamin B6 levels before and during treatment with carbidopa/levodopa therapies.

CREXONT is Amneal’s next-generation extended-release carbidopa/levodopa (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. In May 2026, the FDA approved a labeling update providing an additional administration option for patients who have difficulty swallowing intact capsules, who may now take CREXONT by carefully opening and sprinkling the capsule contents on a small amount of applesauce, which should be immediately consumed.

With enrollment in ELEVATE-PD now complete and patients continuing through the 12-month follow-up period, Amneal will present longer-term outcomes and patient-reported results throughout 2026, building a comprehensive body of evidence for CREXONT’s impact on motor symptom control and functional independence for people living with Parkinson’s disease.

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 Parkinson’s disease experiencing motor complications such as OFF periods and dyskinesia despite being on a stable dose of an oral levodopa-based regimen. The trial has enrolled 232 participants and is currently evaluating them in a 12-month follow-up period, consisting of 4 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.
• Your doctor should evaluate vitamin B6 levels before and during treatment with carbidopa/levodopa therapies as seizures associated with low levels of vitamin B6 have been reported. Traditional anti-seizure medications were not effective, and seizures were only resolved after vitamin B6 administration.
• Other symptoms of vitamin B6 deficiency include depression, confusion, cracked corners of the mouth, swollen tongue, skin inflammation, low red blood cell count, and/or numbness, tingling, or weakness in the extremities. Your doctor may advise you to take vitamin B6 as necessary.
• 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. 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. While PD is not considered a fatal disease, it is associated with significant morbidity and disability. 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.

About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, New Jersey, is a diversified, global biopharmaceutical leader focused on expanding access to affordable and innovative medicines. Founded in 2002 by brothers and co-CEOs Chirag and Chintu Patel, Amneal was built on the belief that innovation only matters if it’s accessible. Today, Amneal has a diverse and growing portfolio of approximately 300 complex, specialty and biosimilar medicines, delivering over 160 million prescriptions each year, primarily in the United States. Our Affordable Medicines segment spans retail, injectable, and biosimilar products. Our Specialty segment provides branded treatments in neurology, including Parkinson’s disease and migraine, and endocrinology. Our AvKARE segment distributes pharmaceuticals and medical products to U.S. federal, retail, and institutional customers. For more information, 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.

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