Rytary (levodopa/carbidopa extended-release capsule) / Amneal - LARVOL DELTA

Plant-Based Therapies To Ameliorate Neuroinflammation In Parkinson's Disease, Alzheimer's Disease And Epilepsy: A Narrative Review. (PubMed, Chem Biodivers) - "Some of the examples are curcumin, resveratrol, ginsenosides, cannabidiol, notoginseng, quercetin etc. Clinical studies also indicate that certain plant-based formulations like Wei Li Bai, IPX066, Bushen huoxue etc., can be effective alternatives to presently available remedies. The review is an attempt at assimilating the information from available literature on the role of different neurotransmitters involved in neuroinflammation and their connection in AD, PD, and, Epilepsy and applications of plant-based therapies in the prevention and cure of the above-mentioned diseases."

Journal • Alzheimer's Disease • CNS Disorders • Epilepsy • Inflammation • Movement Disorders • Parkinson's Disease

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

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

Novel Non-opioid Post-surgical Pain Treatment in Females (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Northwestern University | N=60 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Pain

IPX203 vs Immediate-Release Carbidopa-Levodopa for the Treatment of Motor Fluctuations in Parkinson Disease: The RISE-PD Randomized Clinical Trial. (PubMed, JAMA Neurol) - P3 | "A total of 770 patients were screened, 140 were excluded (those taking controlled-release carbidopa-levodopa apart from a single daily bedtime dose, Rytary (Amneal Pharmaceuticals), additional carbidopa or benserazide, or catechol O-methyl transferase inhibitors or who had a history of psychosis within the past 10 years), and 630 were enrolled in the trial. In this study, IPX203 provided more hours of good on-time per day than immediate-release carbidopa-levodopa, even as IPX203 was dosed less frequently. ClinicalTrials.gov Identifier: NCT03670953."

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

Novel Non-opioid Post-surgical Pain Treatment in Females (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Northwestern University | Trial completion date: Jan 2023 ➔ Jan 2024 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Pain

Parkinson’s Disease Patient Characteristics in a US Real-World Study of Opicapone (ANA 2022) - "Background : Opicapone is an oral, selective, once-daily catechol-O-methyltransferase (COMT) inhibitor used as adjunctive treatment to carbidopa/levodopa (CD/LD) in patients with PD experiencing “OFF”-episodes...11.1% of patients used entacapone before enrollment and were switched to opicapone... Opicapone was added to a variety of CD/LD formulations, including over 20% of patients utilizing Rytary. While the study was conducted during the ongoing pandemic and investigators could initiate treatment via telemedicine, most investigators elected to initiate patients on opicapone with an in-person visit. Findings from OPTI-ON will further characterize the PD population treated with opicapone and real-world clinician- and patient-reported outcomes data in the US will complement results from previous controlled clinical trials."

Clinical • Real-world evidence • CNS Disorders • Parkinson's Disease

Learning and predicting Levodopa regimens from wearable sensors: A novel machine learning approach (MDS Congress 2022) - " Our wearable-based RL policies suggest that the original n=26 study patients would experience lower bradykinesia (and unchanged dyskinesia) if switched to controlled-release L-dopa formulations such as Rytary... We show that pairing machine learning with even small quantities of wearable movement tracker data can offer novel, generalizable clinical insights and medication strategies, which can be used to improve care for other PD patients for whom wearable data are not available."

Late-breaking abstract • CNS Disorders • Parkinson's Disease

"PPMI Parkisons progression marker initiative sponsored by the MJF foundation. Also finished a trial for a rytary type med. Stage 1, what trial is yours?" (@rjmcane2006)

Difference in rural and urban Medicare prescription pattern for Parkinson's disease in Hawai'i. (PubMed, Clin Park Relat Disord) - "In rural Hawai'i, Rytary, Rotigoitne and selegiline were rarely prescribed. In the state of Hawai'i, there is an urban-rural access gap to neurologists as evidenced by Medicare prescription pattern. Further study is needed to understand the reasons for rural-urban differences in prescription patterns and their impact on outcomes."

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

AMNEAL PHARMACEUTICALS, INC. Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q) (Market Screener) - "Specialty segment net revenue decreased $10.8 million during the thee months ended March 31, 2022 as compared to the prior year period, driven by the loss of exclusivity of Zomig® nasal spray as well as a decline in our other non-promoted products. Net revenue for our promoted products, including Rytary® and Unithroid®, declined 6% and increased 13%, respectively, due to the timing of shipments as prescription growth remained strong for both products...Research and Development Specialty R&D expenses for the three months ended March 31, 2022 were $9.6 million, as compared to $12.1 million for the three months ended March 31, 2021. The $2.5 million decrease from the prior year period was primarily attributable to a decrease in in-licensing and upfront milestone payments of $5.0 million and a reduction in IPX-203 spend as the project neared completion, partially offset by increased spend of $3.0 million associated with the KSP Acquisition."

Commercial • CNS Disorders • Migraine • Pain • Parkinson's Disease

BRIEF—Bora Pharma links with Bright Future on PD drug (The Pharma Letter) - "Taiwan drug maker Bora Pharmaceuticals has signed a distribution deal with its Hong Kong-based counterpart Bright Future to supply the extended release (ER) combo drug Numient (carbidopa/levodopa) to treat Parkinson's disease in China, including Hong Kong and Macau....Bora is Amneal's contracted manufacturer for Numient, and holds the commercial rights to the drug in many other Asian countries including Japan, South Korea and Thailand."

Licensing / partnership • CNS Disorders • Parkinson's Disease

Novel Non-opioid Post-surgical Pain Treatment in Females (clinicaltrials.gov) - P2; N=60; Recruiting; Sponsor: Northwestern University; Not yet recruiting ➔ Recruiting

Enrollment open • Pain

AMNEAL PHARMACEUTICALS, INC. Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q) (Market Screener) - "Specialty net revenue for the three months ended September 30, 2021 was $93 million, an increase of $5 million, or 6%, compared to the three months ended September 30, 2020. The overall growth was primarily attributed an increase in Rytary® and Unithroid® revenue of $4 million, or 11%, and $2 million, or 18%, respectively, compared to the prior year period, partially offset by a decline in non-promoted Specialty brands."

Sales • CNS Disorders • Parkinson's Disease

Novel Non-opioid Post-surgical Pain Treatment in Females (clinicaltrials.gov) - P2; N=60; Not yet recruiting; Sponsor: Northwestern University

New P2 trial • Pain

Drugs for Parkinson's disease. (PubMed, Med Lett Drugs Ther) - No abstract available

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

Real-World Experience with Carbidopa-Levodopa Extended-Release Capsules (Rytary): Results of a Nationwide Dose Conversion Survey. (PubMed, Parkinsons Dis) - "Moreover, rapid patient follow-up after initial dose conversion to allow for further dose adjustments plays a critical role in achieving success. Gaining experience over time is important for satisfactory conversion."

Clinical • Journal • Real-World Evidence

Comparison chart: Drugs for Parkinson's disease. (PubMed, Med Lett Drugs Ther) - No abstract available

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

Opicapone (Ongentys) - a COMT inhibitor for Parkinson's disease. (PubMed, Med Lett Drugs Ther) - No abstract available

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

Sublingual apomorphine (Kynmobi) for Parkinson's disease. (PubMed, Med Lett Drugs Ther) - No abstract available

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

Duration of benefit per Dose: Carbidopa-Levodopa immediate release vs. extended release capsules (Rytary®). (PubMed, Parkinsonism Relat Disord) - "In the ADVANCE-PD trial, CD-LD ER significantly increased ON time per dose compared to CD-LD IR (+1.21 h, p < 0.0001) and provided significantly more ON time per dose (3.55 h vs 2.38 h, p < 0.0001)."

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

Amneal Pharmaceuticals, Inc. (AMRX) Q3 2020 Earnings Call Transcript (The Motley Fool) - "Both Rytary and Unithroid continue to show strong growth, with sales up approximately 12% and 29%, respectively, and combined prescriptions volume up 6%....Amneal currently markets Rytary, an extended-release product that is targeted to more moderate to severe patients than generic immediate-release."

Commercial • CNS Disorders • Parkinson's Disease

Rytary: Patient Program Virtual 2020 (Amneal Pharmaceuticals) - "At this event you will learn about ways to help manage Parkinson's disease and treatment with RYTARY from a healthcare provider. You will also hear an inspiring story from someone living with Parkinson's disease."

Live event

Rytary: Patient Program Virtual 2020 (Amneal Pharmaceuticals) - "At this event you will learn about ways to help manage Parkinson's disease and treatment with RYTARY from a healthcare provider. You will also hear an inspiring story from someone living with Parkinson's disease."

Live event

RYTARY Patient Program Virtual 2020 (Amneal Pharmaceuticals) - "At this event you will learn about ways to help manage Parkinson's disease and treatment with RYTARY from a healthcare provider. You will also hear an inspiring story from someone living with Parkinson's disease."

Live event