- Positive CHMP opinion is based on data from the Phase 3 RISE-PD trial, which demonstrated significantly more “Good ON” time with fewer daily doses compared with immediate-release levodopa/carbidopa
- Hopledo® is already approved and marketed in the United States as CREXONT®, providing established regulatory and commercial experience as the therapy advances toward European approval
- More than one million people are living with Parkinson’s disease in the European Union, and over 80% experience motor fluctuations during the course of their disease, highlighting the need for additional treatment options
- Hopledo® contains a unique formulation combining immediate-release granules and extended-release pellets, providing both a rapid onset of action and a longer duration of effect, sustaining the levodopa therapeutic effect for a longer period of time
- If approved, Zambon expects to make Hopledo® progressively available to patients with Parkinson’s disease across Europe starting October 2026
MILAN and BRIDGEWATER, N.J., June 29, 2026 (GLOBE NEWSWIRE) -- Zambon and Amneal Pharmaceuticals today announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorization by the European Medicines Agency (EMA) for Hopledo® (modified-release levodopa/carbidopa) for the treatment of adult patients with Parkinson’s disease and moderate to severe motor fluctuations who have not been sufficiently stabilized with oral levodopa/DDC inhibitor-based treatment regimens.
Hopledo®, formerly known as IPX203, is a novel oral formulation of levodopa/carbidopa that is already approved and marketed in the United States under the brand name CREXONT®. If approved by the European Commission, Hopledo® would provide a new treatment option for patients across Europe who continue to experience motor fluctuations despite current oral therapies.
CHMP recommendation is based on data from the Phase 3 RISE-PD trial, which compared Hopledo® with immediate release levodopa/carbidopa (LD/CD) formulation in patients with Parkinson’s disease and moderate to severe motor fluctuations. In the study, Hopledo® demonstrated a significant increase in Good ON time over immediate release LD/CD with fewer daily doses and a comparable safety profile1.
Hopledo® is a first-in-class, oral, modified-release formulation of LD/CD designed for the treatment of fluctuations of Parkinson’s disease, the fastest growing neurological condition in the world according to the World Health Organization2. Despite available oral treatments, there is a substantial need for new therapeutic options; during the course of the disease, more than 80% of patients with Parkinson’s disease experience motor fluctuations3. Hopledo® contains a unique formulation combining immediate-release granules and extended-release pellets, providing both a rapid onset of action and a longer duration of benefit, sustaining the levodopa therapeutic effect for a longer period of time. In 2024, Zambon entered into an exclusive licensing agreement with Amneal Pharmaceuticals for the commercialization of Hopledo® in the European Union, United Kingdom and Switzerland.
“In Parkinson’s disease treatment is focused on maintaining consistent symptom control by prolonging levodopa benefit, reducing “Off” time, and simplifying dosing. Hopledo ability to extend “Good On” time with fewer daily doses offers a significant advancement in the management of motor symptoms and in achieving more stable and sustained therapeutic effects,” said Prof. Fabrizio Stocchi, Full Professor of Neurology at San Raffaele University in Rome and Head of Clinical Research in Movement Disorders and of the Parkinson’s Disease Research Centre.
“The CHMP positive opinion represents an important step towards expending access to this important therapy to patients in Europe. As the disease progresses, many patients require frequent dosing yet continue to face motor fluctuations. Hopledo addresses this unmet need by providing longer-lasting “Good On” time with fewer daily doses. This achievement underscores Zambon’s leadership in Parkinson’s disease and our unwavering commitment to more than one million people currently living with Parkinson’s disease in the EU,” said Mathias Knecht, M.D., Chief Medical Officer Innovative Therapies, Zambon.
Subject to European Commission approval, Zambon expects to begin the phased introduction of Hopledo® across European markets beginning in October 2026. Zambon and Amneal are working closely with the healthcare authorities and other stakeholders to support timely patient access to this important new treatment option.
This milestone also underscores the continued growth and strategic opportunity of Amneal’s expanding International business. With CREXONT® already approved and marketed in the United States, the advancement of Hopledo® in Europe demonstrates Amneal’s ability to extend the reach of its differentiated medicines globally through strong regional partnerships and disciplined execution. Amneal’s international expansion strategy combines partnerships across key markets around the world with a direct commercial presence in India, enabling the company to broaden its footprint across specialty, generics and biosimilars. Together, these efforts are building a strong foundation for sustained international growth and increased access to high-quality medicines for patients worldwide.
About the RISE-PD Phase 3 Trial
The multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group RISE-PD trial evaluated the efficacy and safety of IPX203 compared with IR LD/CD in the treatment of patients with PD with motor fluctuations. The primary endpoint of the trial assessed the change from baseline in “Good On” time in hours per day at the end of the double-blind treatment period (Week 20 or early termination). Secondary endpoints assessed the change from baseline in “Off” time in hours per day, proportion of patients who were either “much improved” or “very much improved” in Patients' Global Impression of Change (PGI-C) scores, change from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score, and the change from baseline in sum of MDS-UPDRS Parts II and III scores. The study included 506 patients who had received a PD diagnosis at age 40 or older.
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.
U.S. INDICATION
CREXONT® (carbidopa and levodopa) extended-release capsules is a prescription medication for the treatment of Parkinson’s disease, Parkinson’s disease caused by infection or inflammation of the brain, or Parkinson’s disease-like symptoms that may result from carbon monoxide or manganese poisoning in adults.
U.S. 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.
- The most common side effects that may occur with CREXONT are nausea and anxiety.
- It is important to avoid sudden discontinuation or rapid dose reduction of 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 CREXONT capsules. If you have difficulty swallowing the capsule, twist apart both halves and sprinkle the entire contents of both halves of the capsule on a small amount of applesauce (1 to 2 tablespoons). Consume the mixture immediately. Do not store the drug/food mixture for future use.
- 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.
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 Zambon
Zambon is a multinational chemical-pharmaceutical company established in 1906 in Vicenza, whose history is founded on the values of an Italian family committed to innovating cure & care to make patients’ lives better. It employs more than 2,700 people worldwide, it is present in 23 countries in Europe, America and Asia, and has production facilities in Italy, Switzerland, China and Brazil. Thanks to its innovative, quality products commercialized in 87 countries, Zambon reported a revenue of 885 million euros in 2024. Alongside the three historical therapeutic areas - diseases of the respiratory system, urinary tract infections and pain treatment – Zambon is focused on developing treatments for neurodegenerative diseases such as Parkinson's or rare diseases such as cystic fibrosis, BOS (Bronchiolitis Obliterans Syndrome) to which is linked the major 2019 acquisition of Breath Therapeutics, and NCFB (Non‐cystic Fibrosis Bronchiectasis). For further information on Zambon please visit www.zambon.com
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.
Zambon contact
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Amneal contact
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References
1. Hauser RA, et al. JAMA Neurol. 2023;80(10):1062-1069 and Supplementary materials
2. htps://www.who.int/publica ons/i/item/9789240050983
3. Fabbri M, et al. Off-time Treatment Options for Parkinson’s Disease. Neurol Ther. 2023;12(2):391-424;
Demailly A, et al. Effectiveness of Continuous Dopaminergic Therapies in Parkinson’s Disease: A Review of L-DOPA Pharmacokinetics/ Pharmacodynamics. J Parkinsons Dis. 2024;14(5):925-939.
