ropinirole extended-release / Generic mfg. - LARVOL DELTA

Update on Treatments for Parkinson's Disease Motor Fluctuations - An International Parkinson and Movement Disorder Society Evidence-Based Medicine Review. (PubMed, Mov Disord) - "There are several treatment options that can improve motor fluctuations in PD. These recommendations will assist physicians and patients in determining which intervention to use."

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

Comparative efficacy and safety of adjunctive drugs to levodopa for fluctuating Parkinson's disease - network meta-analysis. (PubMed, NPJ Parkinsons Dis) - "According to the surface under the cumulative ranking curve (SUCRA) in the NMA, ropinirole transdermal patch (SUCRA, 0.861) ranked the highest in efficacy, followed by pramipexole (0.762), ropinirole extended release (ER) (0.750), and safinamide (0.691). Each anti-PD drug had different SUCRA ranking profiles for the safety outcomes. These findings suggest that ropinirole, pramipexole, and safinamide are well-balanced anti-PD drugs that satisfy both efficacy and tolerability outcomes."

Journal • Retrospective data • CNS Disorders • Hypotension • Movement Disorders • Parkinson's Disease • ADORA2A

Comparative efficacy and safety of six non-ergot dopamine-receptor agonists in early Parkinson's disease: a systematic review and network meta-analysis. (PubMed, Front Neurol) - "Novel long-acting formulations of NEDAs including pramipexole extended-release (ER), ropinirole prolonged-release (PR), and rotigotine transdermal patch have been developed. In addition, the incidence of adverse reaction of ropinirole IR was relatively high (nausea: 0.678; somnolence: 0.752; dizziness: 0.758; fatigue: 0.890). In this systematic review and network meta-analysis of six NEDAs, piribedil exhibited better efficacy, especially as monotherapy, and ropinirole IR was associated with a higher incidence of adverse events in patients with early PD."

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

Efficacy and Safety of Non-Ergot Dopamine-receptor Agonists as an Adjunct to Levodopa in Advanced Parkinson's Disease: A Network Meta-Analysis. (PubMed, Eur J Neurol) - "This network meta-analysis suggests six commonly used NEDAs are effective as an adjunct to levodopa in advanced PD. In comprehensive consideration of better symptomatic management, ropinirole PR may be a better choice than other NEDAs in advanced PD. Six NEDAs showed different profiles of AEs."

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

Comparison of efficacy and safety of adjunct treatments to levodopa in patients with Parkinson’s disease and wearing-off: A network meta-analysis of randomized, double-blind trials (MDS Congress 2022) - "Twelve drugs available in Japan for PD patients with wearing-off (pramipexole IR/ER, ropinirole IR/ER/transdermal patch, rotigotine transdermal patch, entacapone, opicapone, istradefylline, selegiline, rasagiline, and safinamide) were included in the study...For Off-time, 11 out of 12 active drugs were superior to placebo, and SUCRA was greater for ropinirole transdermal patch (86.1%), pramipexole IR (76.2%), ropinirole ER (75.0%), and safinamide (69.1%)... We found balanced efficacy and tolerability in dopamine agonists and safinamide. Further studies will be needed since the number of head to head trials was limited."

Retrospective data • CNS Disorders • Parkinson's Disease

Comparative Efficacy and Safety of Dopamine Agonists in Advanced Parkinson's Disease With Motor Fluctuations: A Systematic Review and Network Meta-Analysis of Double-Blind Randomized Controlled Trials. (PubMed, Front Neurosci) - "The general DA effects were ranked from high to low with respect to the amount of "ON" time without troublesome dyskinesia as follows: apomorphine (SUCRA = 97.08%), pramipexole_IR (probability = 79.00%), and ropinirole_PR (SUCRA = 63.92%). The general safety of DAs was ranked from high to low with respect to TEAE as follows: placebo (SUCRA = 74.49%), pramipexole_ER (SUCRA = 63.6%), sumanirole (SUCRA = 54.07%), and rotigotine (SUCRA = 53.84%)...The addition of pramipexole, ropinirole, or rotigotine to levodopa treatment in advanced PD patients with motor fluctuations increased "ON" time without troublesome dyskinesia, improved the UPDRS III scores, and ultimately ameliorated the UPDRS II scores, thereby maximizing its benefit. This NMA of pramipexole, ropinirole, and rotigotine represents an effective treatment option and has an acceptable safety profile in patients with advanced PD."

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

Ropinirole Patch Versus Placebo, Ropinirole Extended-Release Tablet in Advanced Parkinson’s Disease. (PubMed, Mov Disord) - "Once-daily ropinirole patch was effective in advanced PD patients, having demonstrated superiority over placebo and noninferiority to ropinirole tablet, without causing serious safety problems. Ropinirole patch can be an alternative option for PD patients."

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

Structure Elucidation and Mechanistic Study of a New Dimeric Degradant in Ropinirole Hydrochloride Extended-Release Tablets. (PubMed, Pharm Res) - "The newly occurred unknown degradant in ropinirole extended-release tablets was elucidated as the methylene-bridged 1,3'-Dimer of ropinirole. Based on the mechanistic study, 1,3'-Dimer and its isomer (3,3'-Dimer) were both formed by the reaction of ropinirole with residual formaldehyde present or formed in lactose, a main excipient of the formulation."

Journal

TRANSDERMAL PATCH OF ROTIGOTINE AMELIORATES FREEZING OF GAIT DURING WEARING OFF IN PATIENTS WITH PARKINOSON’S DISEASE (WCN 2017) - "...We aimed to examine how three non-ergot DAs of Rot, pramipexole LA (PraL) and ropinirole CR (RopC) influences FOG in PD patients with Yahr stage 3-4... The present study suggests that Rot transdermal patch attenuated FOG during off time. The similar D1-D5 receptors binding affinity between Rot and dopamine, and 24-hours steady hemodynamics could contribute to the therapeutic mechanism of FOG in PD patients with wearing off."

Clinical • CNS Disorders • Parkinson's Disease

Comparative analysis of use of long acting dopamine agonists in current clinical practice: ongoing survey across Europe (EFNS 2011) - N=64; Rotigotine skin patch (RTG) used in 64 (average dose 9.87mg), ropinirole (ROP) XL (N=27, 12.7mg), pramipexole (PPX) SR (N=21, 2.5mg) with RR of 89% for RTG, 89% for ROP XL and 100% for PPX SR (numbers on ROP and PPX are currently low); In old PD (≥75yrs), 12 RTG, 8 ROP XL and 5 PPX SR continue with no intolerance; 15.3% cases report successful tolerability of 2 or more DA's, while 9 cases (6.3%) of impulse control disorders (ICD) are reported, all in cases exposed to immediate release preparations

Questionnaire data • Parkinson's Disease

Improvements in nocturnal symptoms with ropinirole prolonged release in patients with advanced Parkinson's disease (Eur J Neurol) - P3, N=387; Nocturnal symptoms in advanced PD pts significantly improved with ropinirole PR vs. PBO in PDSS score from baseline to wk 24; PDSS≤ 100 subgroup showed treatment benefits for PDSS groupings of motor symptoms on waking & global quality of sleep; PDSS>100 subgroup showed treatment benefit for global quality of sleep; Unadjusted odds ratio for a positive response with ropinirole PR vs PBO for PDSS≤ 100 subgroup was 2.9 (p=0.004)

P3 data • Parkinson's Disease

Dr Reddy's launches Parkinson's drug in US (The Economic Times) - Drug maker Dr Reddy's Laboratories has launched in the US market ropinirole XR tablets used to treat the signs & symptoms of PD

Generic launch • Parkinson's Disease

12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome (clinicaltrials.gov) - P4; N=39; Completed; Sponsor: GlaxoSmithKline; N=216 -> 39

Enrollment change • Biosimilar

Actavis launches first generic equivalent of Requip XL (ropinirole extended-release tablets) (PRNewswire) - Actavis has received US FDA approval of ropinirole extended-release tablets, 2mg, 4mg, 6mg, 8mg and 12mg, a generic equivalent to GlaxoSmithKline's Requip XL; Actavis believes this is first generic Requip XL available in US

Generic approval • Parkinson's Disease

Comparison of once-daily versus twice-daily combination of ropinirole prolonged release in Parkinson's disease (16th International Congress of Parkinson’s Disease and Movement Disorders) - P4, N=82; NCT00986245; Ropirinole PR is a once-daily formulation, but multiple dosing was preferred in many patients; Multiple dosing of Ropinirole PR needs to be tried if once-daily dosing is unsatisfactory

P4 data • Parkinson's Disease

Overnight switching from pramipexol to ropinirole CR in patient with idiopathic Parkinson's disease: An open preliminary trial in Korean (ADPD 2013) - Presentation time: NA; P3, N=30; NCT00275275; "An overnight switching of pramipexole to ropinirole CR is safe and well tolerated. The majority of subjects preferred ropinirole CR due to reducing constipation, dyskinesia, fatigability and day time sleepiness, and convenience. The conversion ratio of 1:4 was effective pramipexole to ropinirole CR."

P3 data • Parkinson's Disease

Pharmacokinetics and effect of food after oral administration of prolonged-release tablets of ropinirole hydrochloride in Japanese patients with Parkinson's disease (J Clin Pharm Ther) - P3, N=302; NCT00823836; The trough concentrations of ropinirole & two metabolites increased in proportion to dose when ropinirole hydrochloride prolonged-release tablets were administered at doses ranging from 2 to 16mg/day; Compared with IR tablet, prolonged-release tablet can be administered to Japanese pts with PD at a reduced daily dose frequency & adjusted to the maintenance dose after fewer dose changes with a smaller diurnal variation in plasma ropinirole concentration

Pharmacokinetic data • Parkinson's Disease

Tolerability of non-ergot oral and transdermal dopamine agonists in younger and older Parkinson's disease patients: an European multicentre survey. (PubMed, J Neural Transm (Vienna)) - "This study addressed the tolerability (Shulman criteria, continued intake of DA therapy for at least 6 months) in PD patients across several European centres treated with long-acting and transdermal DA (Rotigotine skin patch, Ropinirole extended release, or Pramipexole prolonged release) as part of routine clinical care in younger and older PD patients. Tolerability was above 90% irrespective of age, with no significant differences between younger and older patients. Based on our findings, we suggest that long-acting/transdermal DA are tolerated in non-demented older patients, as well as in younger patients, however, with lower daily dose in older patients."

Clinical • Journal • CNS Disorders • Gene Therapies • Genetic Disorders • Movement Disorders • Parkinson's Disease

Comparison of long-term use of prolonged-release ropinirole and immediate-release dopamine agonists in an observational study in patients with Parkinson's disease. (PubMed, Pharmacoepidemiol Drug Saf) - "The number of dyskinesia and ICD events was lower than expected, resulting in an underpowered study. A significantly longer persistence and greater adherence to medication was observed in patients receiving R-PR compared to IR-DA."

Clinical • Journal • Observational data

BUDGET IMPACT OF ROTIGOTINE ON CHINESE NATIONAL MEDICAL FUND PAYMENT FOR PARKINSON’S DISEASE (ISPOR-EU 2019) - "The cost of seven DAs were measured, i.e. Neupro marketed by UCB, Piribedil, pramipexole extended release, immediate release and generic, and ropinirole extended release and generic. The incremental payment for PD caused by rotigotine was not projected to be able to cause great financial strain on Chinese NMF, judging by amount and percentage. However, listing rotigotine will improve the accessibility to and affordability of patients for innovative PD drugs."

HEOR

Hyundai Pharmaceutical launches Korea’s first Parkinson’s disease treatment (Business Korea) - "Hyundai Pharmaceutical announced on June 20 that it has launched Korea’s first Parkinson's disease treatment Ropinirole hydrochloride (HCl)....The Hyundai Ropinirole tablet is an extended release type of medication and is more convenient to administer as it is taken once a day..."

Generic launch