Carbidopa/Levodopa

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 Dec. 05, 2025 -- 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.” 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 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. 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. 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 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. The content above comes from the network. if any infringement, please contact us to modify.

NEW YORK--(BUSINESS WIRE)--Laxxon Medical, a leading pharmaceutical technology company pioneering a new generation of advanced oral drug delivery systems, today announced the publication of a new study in the Journal Pharmaceutics (MDPI) that highlights the effectiveness of its proprietary carbidopa/levodopa formulations (LXM.5) for the treatment of Parkinson's disease. The pharmacokinetic study demonstrated that Laxxon’s novel dosage forms significantly improved bioavailability compared to Sinemet® (carbidopa/levodopa), a current standard treatment option for Parkinson’s disease. “Levodopa remains the gold standard for treating Parkinson’s disease, but its short half-life is associated with the development of motor complications due to pulsatile dopamine levels in the brain,” said Dr. Dieter Volc, study investigator and leading clinician in the field of Parkinson Disease at the Atomos Klinik in Vienna. “Our findings show that SPID®-Technology enables controlled, sequential release of carbidopa and levodopa, resulting in significantly improved bioavailability and stable blood plasma levels. This represents a meaningful step toward reducing complications associated with traditional therapies, and it highlights the potential of this platform to reshape oral drug delivery in neurology and other therapeutic areas.” Laxxon Medical’s SPID®-Technology Platform leverages precision-engineered screen-printing methods to produce pharmaceutical tablets with tailored microstructures, enabling controlled, consistent, and prolonged levodopa release profiles for optimized therapeutic outcomes. In the study, a novel screen-printing approach was employed to create advanced oral dosage forms that deliver carbidopa and levodopa, the two primary drugs used in the treatment of Parkinson’s disease in a unique sequential form. The new formulations, LXM.5, separate the active ingredients into distinct compartments, allowing for more precise timing of drug release. In LXM.5 the incorporated enteric polymers in the Levodopa compartment played an additional role to the sequential release of the two different drugs. Lab and pharmacokinetic (PK) studies compared these new formulations to traditional Sinemet®, a commonly used Parkinson’s disease therapy that combines carbidopa and levodopa homogeneously distributed within the tablet. Study results showed that Laxxon’s new formulations successfully released the medications in sequence, but the additional controlling of the release of Levodopa through pH sensitive polymers caused a further increase of the bioavailability (>380%) and an extended AuC. Importantly, both new versions (dosed at 100 mg levodopa and 25 mg carbidopa) delivered significantly more levodopa into the bloodstream, showing 2 to nearly 4 times the bioavailability of Sinemet® (100/25). Blood levels were also more continuous over time, especially with LXM.5-2, potentially offering improved symptom control for patients. Additionally, the PK profile indicates a reduction in the required frequency of daily administrations. “This study marks a pivotal validation of our SPID®-Technology and its ability to precisely control drug release through advanced screen printing,” said Achim Schneeberger, M.D, Chief Science Officer at Laxxon Medical. “By enabling spatial separation and integration of enteric, pH-sensitive polymers into drug-containing compartments, we enable tailored release profiles within a single oral dosage form. This advancement presents an opportunity to enhance existing therapies, potentially leading to a new class of personalized, high-performance drug delivery solutions that could extend beyond the treatment of Parkinson’s disease." The complete study is available online at www.sciencedirect.com/journal/international-journal-of-pharmaceutics. About Laxxon Medical Laxxon Medical, founded in 2017, is transforming pharmaceutical development through its proprietary SPID®-Technology, an advanced additive manufacturing platform engineered to produce next-generation oral dosage forms. This technology enables unparalleled precision in sequential drug release and supports complex formulation strategies, including peptide oral delivery, nanoparticle processing, multifunctional polymer integration, multicompartment microtablets, and targeted drug delivery. SPID®-Technology offers distinct competitive advantages in lifecycle management and novel drug development, addressing critical needs across both the pharmaceutical and biotechnology sectors. Beyond its collaborations with industry partners, Laxxon utilizes SPID® to drive its pipeline of proprietary and generic therapeutics, focused on metabolic disorders and central nervous system (CNS) conditions. Laxxon's pipeline includes ongoing working-projects with notable pharma players, biotech companies and research universities, in addition to 10 in-house Advanced Patented Generics products. Laxxon's IP is continuously growing, and together with the licensed IP from Exentis Group, consists of more than 230 patents and patent applications with more than 5,000 patent claims. For more information on Laxxon Medical and its technology platforms, go to: www.laxxonmedical.com and follow us on LinkedIn.