Crexont (levodopa/carbidopa extended-release capsule) / Amneal, Knight Therap - LARVOL DELTA

IPX203-401-23: A Study of CREXONT (Carbidopa and Levodopa) Extended-Release Capsules in Participants With Parkinson's Disease (clinicaltrials.gov) - P4 | N=220 | Recruiting | Sponsor: Impax Laboratories, LLC | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

HOW THE THERAPEUTIC APPROACH TO EARLY PARKINSON'S DISEASE WILL CHANGE IN THE NEXT FUTURE (ADPD 2025) - "Levodopa remains the most efficacious drug, a better preparation of levodopa like IPX 203 can ensure more stable plasma levels of Levodopa...Tavapadon is a new dopamine agonist stimulating D1-D5 receptors which concluded the phase III. Other compounds such as CVN424 (Cerevance) orally active and selective GPR6 inverse agonist, piperamat (IRLAB 752) a cortical enhancer to improve balance, Clenbuterol/Nadolol for cognition, mesdopetam a D3 antagonist are under investigation...These include the monoclonal antibody prasinezumab, UCB0599 and buntanetap small-molecules α-synuclein aggregation inhibitor, the vaccine ACI-7104.056 by AC immune...The LRKK2 kinase inhibitor BIIB122/DNL151 is in phase IIb in PD. BIAL BIA 28-6156 activator of the GCase enzyme is under investigation in patients with GBA mutation. The combination of symptomatic and disease modifying therapy, the use of accurate biomarkers and more precise treatment will be the future in the treatment of PD."

CNS Disorders • Movement Disorders • Parkinson's Disease • GBA

Impact of CREXONT on Parkinson's Patients' Motor States Upon Awakening: Analysis of Patient Diary Data (P11-5.010). (PubMed, Neurology) - "CREXONT is a novel extended-release, oral carbidopa-levodopa (CD-LD) formulation that provides fast onset and prolonged duration of "On". Richard DSouza has received personal compensation for serving as an employee of Amneal Pharmaceuticals. Richard DSouza has stock in Amneal Pharmaceuticals ."

Clinical • Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

Amneal Announces New Data from Phase 3 Study Showing Significant Improvements in Sleep Quality with CREXONT (Carbidopa and Levodopa) Extended-Release Capsules in Parkinson’s Disease (Businesswire) - P3 | N=630 | RISE-PD (NCT03670953) | Sponsor: Impax Laboratories, LLC | "Amneal Pharmaceuticals, Inc...announced a new analysis of the pivotal RISE-PD Phase 3 study showed that patients who successfully converted to CREXONT from immediate release (IR) carbidopa/levodopa (CD/LD) experienced statistically significant improvements in sleep quality....The new analysis showed that patients on CREXONT, compared to IR CD/LD, also experienced statistically significant improvements across all PDSS-2 subdomains, including reduced disturbed sleep (-1.07, p<0.0001), improved nighttime motor symptoms (‑0.62, p<0.0059) and PD symptoms at night (-0.65, p<0.0017). Full results will be presented at the American Academy of Neurology (AAN) 2025 Annual Meeting on April 9 at 8 a.m. PST."

P3 data • Parkinson's Disease

Amneal Announces Expanded Coverage for CREXONT (Carbidopa and Levodopa) to Enhance Access for Parkinson’s Disease Patients in the U.S. (Businesswire) - "Amneal Pharmaceuticals, Inc...announced that three large insurance coverage accounts, the Veterans Administration (VA), UnitedHealthcare and CVS Health, have added CREXONT (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease (PD) to their national prescription drug formularies...This expanded coverage increases CREXONT’s total U.S. insurance coverage from about 30% of covered lives at the end of 2024 to over 50%. The Company had initially set a goal to surpass 50% coverage by the end of 2025, making this milestone—achieved nine months ahead of schedule—a testament to Amneal’s commitment to broadening patient access...UnitedHealthcare will add CREXONT to its standard prescription drug lists in the second quarter of 2025. In addition, CVS Health will add CREXONT as a 'preferred' product to its national formulary on July 1, 2025."

US reimbursement • Parkinson's Disease

Impact of Concomitant Therapy with a Dopamine Agonist on Converting Parkinson's Disease Patients from Immediate-release Carbidopa-levodopa to CREXONT® (AAN 2025) - "Converting patients from IR CD-LD to CREXONT improved GOT in all subgroups, with the highest benefit in those receiving 200mg or less DA LEDD. While patients on higher DA doses also benefited from conversion, GOT gain was reduced by 40% compared to the low dose group."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease

Efficacy and Safety of IPX203 in Parkinson's Patients: A Systematic Review and Meta-analysis (AAN 2025) - "IPX203 shows a significant potential in improving motor functions, reducing "off" time while increasing "good on" time. This makes IPX203 a valuable addition to current PD treatment strategies."

Retrospective data • Review • CNS Disorders • Movement Disorders • Parkinson's Disease

Impact of CREXONT on Parkinson's Patients' Motor States Upon Awakening: Analysis of Patient Diary Data (AAN 2025) - "Objective:To evaluate "On" upon awakening in Parkinson's disease patients taking CREXONT in the RISE-PD phase 3 clinical trial.Background:CREXONT is a novel extended-release, oral carbidopa-levodopa (CD-LD) formulation that provides fast onset and prolonged duration of "On". CREXONT treatment resulted in significant increase in patients waking up "On" during the study period. At EOS, a significantly higher percentage of patients on CREXONT were never "Off" upon awakening vs patients on IR CD-LD. Significantly lower percentage of patients recorded to never be "On" upon awakening in the CREXONT group vs IR CD-LD."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease

Conversion to CREXONT® in the RISE-PD Phase 3 Trial Improved Aspects of Sleep as Measured by the Parkinson's Disease Sleep Scale-2 (PDSS-2) (AAN 2025) - "Objective:To assess whether converting patients with Parkinson's disease (PD) to CREXONT improves Parkinson's Disease Sleep Scale-2 (PDSS-2) total and sub-scale scores.Background:CREXONT is a novel extended-release, oral carbidopa-levodopa (CD-LD) formulation that improves LD pharmacokinetics. Conversion to CREXONT significantly improved sleep quality in PD patients, as measured by PDSS-2, addressing both sleep disturbances and nighttime motor symptoms."

P3 data • CNS Disorders • Movement Disorders • Parkinson's Disease • Sleep Disorder

Industry Therapeutic Update from Amneal Pharmaceuticals: Innovation and outcomes: A case-based discussion about CREXONT® (carbidopa and levodopa) extended-release capsules (AAN 2025) - "Sponsored by Amneal Pharmaceuticals."

Clinical

Industry Therapeutic Update from Amneal Pharmaceuticals: Innovation and outcomes: A case-based discussion about CREXONT® (carbidopa and levodopa) extended-release capsules (AAN 2025) - "The AAN cannot affirm claims pertaining to FDA off-label medication, research use of pre-FDA drugs, or other research information that might be discussed. Industry Therapeutic Updates are industry events."

Clinical

Amneal Reports Fourth Quarter and Full Year 2024 Financial Results (Businesswire) - "Net revenue in the fourth quarter of 2024 was $731 million, an increase of 18% compared to $617 million in the fourth quarter of 2023. The increase was driven by Affordable Medicines(3) revenues growing 21% due to new product launches, biosimilars and multiple other complex products, AvKARE revenues growing 14% due to new product launches and Specialty revenues growing 16% driven by key branded products including CREXONT."

Commercial • CNS Disorders • Parkinson's Disease

A Study of CREXONT (Carbidopa and Levodopa) Extended-Release Capsules in Participants With Parkinson's Disease (clinicaltrials.gov) - P4 | N=220 | Not yet recruiting | Sponsor: Impax Laboratories, LLC

New P4 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

Duration of "Good On" time per dose: Immediate-release carbidopa-levodopa vs. extended-release carbidopa-levodopa (IPX203, CREXONT®). (PubMed, Parkinsonism Relat Disord) - "IPX203 significantly increased "Good On" time per dose regardless of the duration of "Good On" time per dose observed with IR CD-LD."

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

Impact of IPX203 on Parkinson’s patients’ motor states upon awakening: analysis of patient diary data (MDS Congress 2024) - "IPX203 treatment resulted in significant increase in patients waking up "On" during the study period. At EOS, a significantly higher percentage of patients on IPX203 were never "Off" upon awakening compared to patients on IR CD-LD. In addition, significantly less patients reported to never be "On" upon awakening in the IPX203 group vs IR CD-LD."

Clinical • CNS Disorders • Parkinson's Disease

Amneal Launches CREXONT (Carbidopa and Levodopa) Extended-Release Capsules for Treatment of Parkinson’s Disease (Businesswire) - "Amneal Pharmaceuticals, Inc...announced that it has launched CREXONT (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease. CREXONT is a novel, oral formulation of carbidopa/levodopa (CD/LD) that combines both immediate-release granules and extended-release pellets. CREXONT is now broadly available at U.S. pharmacies."

Launch US • CNS Disorders • Parkinson's Disease

Innovation in "On" time is Here: Introducing CREXONT® (carbidopa and levodopa) Extended-Release Capsules (MDS Congress 2024) - "Sponsored by Amneal Pharmaceuticals LLC"

CNS Disorders

Extended-Release Carbidopa-Levodopa: How is IPX203 different from IPX066? (ANA 2024) - "These data confirm that both IPX066 and IPX203 have ER LD pharmacokinetic profiles. Levodopa concentrations were sustained for a longer duration with IPX203 compared to IPX066; the pharmacodynamic effects were consistent with LD pharmacokinetics."

CNS Disorders • Parkinson's Disease

Breakthrough in Parkinson's Disease Treatment: New Drug Offers Hope (YouTube) - "Dr. Robert Hauser...discusses IPX203 - a promising new medication for Parkinson's patients."

Video

Amneal Receives U.S. FDA Approval for IPX203 for Treatment of Parkinson’s Disease to Be Launched as CREXONT (Carbidopa and Levodopa) Extended-Release Capsules (Businesswire) - "Amneal Pharmaceuticals...announced that the U.S. Food and Drug Administration (FDA) has approved CREXONT (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease (PD). CREXONT is a novel, oral formulation of carbidopa/levodopa (CD/LD) that combines both immediate-release (IR) granules and extended-release (ER) pellets....CREXONT demonstrated a statistically significant improvement of 0.5 hours of additional 'Good On' time per day compared to IR CD/LD, with an average of three times a day dosing with CREXONT compared to five times a day dosing with IR CD/LD, in the RISE-PD clinical trial....Amneal expects to make CREXONT available to patients in the U.S. in September 2024."

FDA approval • Launch US • Parkinson's Disease

Continuous subcutaneous levodopa/carbidopa infusion with ND0612 for patients with Parkinson’s disease and motor fluctuations: Results from the Phase 3 randomized, active-controlled BouNDless study (ATMRD 2024) - No abstract available.

P3 data

IMPROVEMENT OF MOTOR AND NON-MOTOR SYMPTOMS WITH BEZISTERIM (NE3107) ADJUNCTIVE TO CARBIDOPA/LEVODOPA IN PATIENTS WITH PARKINSON’S DISEASE: A PHASE 2A, PLACEBO-CONTROLLED STUDY (ATMRD 2024) - No abstract available.

P2a data

Extended-release carbidopa-levodopa: How is IPX203 different from IPX066? (ATMRD 2024) - No abstract available.

How to dose extended-release carbidopa-levodopa capsules (IPX203) in Parkinson’s disease patients: Experience from the Phase 3 clinical trial (ATMRD 2024) - No abstract available.

P3 data

Emerging Novel Therapies in Development for PD (NeurologyLive) - "Kremens gave thoughts on the use of several investigational continuous agents, including IPX203, risvodetinib, and P2B001."

Video