pramipexole ER / Generic mfg. - LARVOL DELTA

Impulse control and correlation to dopamine agonist serum concentrations in people with Parkinson's disease. (PubMed, J Neurol) - "Our main finding is that impaired impulse control is correlated to both total drug exposure (AUC) and dopamine agonist dose for ropinirole, but not for pramipexole. These observations indicate that different strategies may be useful for treating PD patients with impaired impulse control: ropinirole dose reduction could be beneficial, whereas pramipexole treatment may have to be stopped."

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

A Study to Evaluate in Patients With Parkinsonian Type Disorders (clinicaltrials.gov) - P2 | N=24 | Active, not recruiting | Sponsor: Chase Therapeutics Corporation | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

A Randomized Phase 3 Study Comparing P2B001 to its Components (Low-Dose Extended-Release Rasagiline and Pramipexole) and to Optimized Doses of Marketed Extended-Release Pramipexole in Early Parkinson's Disease. (PubMed, Mov Disord) - P3 | "P2B001 had superior efficacy to its individual components and was comparable with commercially used doses of pramipexole-ER with less worsening of sleepiness and fewer dopaminergic adverse events. These findings support considering once-daily P2B001 as initial therapy for patients with early PD."

Journal • P3 data • CNS Disorders • Hypotension • Movement Disorders • Parkinson's Disease • Psychiatry

A Study to Evaluate in Patients With Parkinsonian Type Disorders (clinicaltrials.gov) - P2 | N=24 | Active, not recruiting | Sponsor: Chase Therapeutics Corporation | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

Safety and efficacy of P2B001 (low dose combination of extended-release pramipexole and rasagiline) in patients with early Parkinson’s disease: Subgroup analyses from a randomized, (MDS Congress 2023) - "For patients with different ages (younger vs older) and baseline symptom severities, these findings support consistent symptomatic control with P2B001, with comparable efficacy to marketed titrated PramiER, yet with reduced excessive daytime sleepiness."

Clinical • CNS Disorders • Excessive Daytime Sleepiness • Parkinson's Disease • Sleep Disorder

Comparative Pharmacokinetics and Bioequivalence Evaluation of Two Formulations of Pramipexole Dihydrochloride Extended-Release Tablets in Healthy Chinese Subjects Under Fasted and Fed States: A Randomized, Open-Label, Single-Dose, Two-Period Crossover Clinical Trial. (PubMed, Drug Des Devel Ther) - "However, pharmacokinetic properties of extended-release pramipexole in healthy Chinese subjects remain unclear. Test and reference formulations showed similar bioequivalence and favorable safety under fasted and fed states. Test and reference formulations of pramipexole dihydrochloride extended-release tablets (0.375 mg) showed similar bioequivalence and well safety and tolerability in healthy Chinese subjects under fasted and fed states, which supports further investigations of test formulation in patients with Parkinson's disease."

Journal • PK/PD data • CNS Disorders • Movement Disorders • Parkinson's Disease

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

P2B001 (low dose combination of extended-release pramipexole and rasagiline) versus titrated extended-release pramipexole in the management of early Parkinson’s disease: Exploratory findings from a randomized, controlled trial (AAN 2023) - "Rates of somnolence (14.7% versus 31.1%) and orthostatic hypotension (2.7% versus 12.2%) were also lower with P2B001 compared with Prami-ER. Conclusions These data indicate that P2B001 offers a once daily treatment option (without the need for titration) for patients with early PD with comparable efficacy to marketed Prami-ER but with reduced sleep-related and dopaminergic side effects."

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

P2B001 significantly reduced risk of daytime sleepiness: results from a randomized controlled phase 3 trial with active pramipexole arm in early Parkinson’s disease (PD) (AAN 2023) - "Design/Methods Untreated patients (time from diagnosis<3 years) were randomized (2:2:2:1) to 12-weeks double-blind treatment with P2B001, pramipexole-ER-0.6mg (PPX), rasagiline-ER-0.75mg (RAS), or marketed ER-PPX (6-week titration). Conclusions EDS is a limiting factor for traditional dosing of DAs. With similar efficacy to ER-PPX monotherapy, patients treated with P2B001 developed significantly less new-onset EDS and fewer sleepiness-related TEAEs."

Clinical • P3 data • CNS Disorders • Excessive Daytime Sleepiness • Movement Disorders • Parkinson's Disease • Sleep Disorder

A Phase 3 Study With P2B001 in Subjects With Early Parkinson's (clinicaltrials.gov) - P3 | N=544 | Completed | Sponsor: Pharma Two B Ltd. | Unknown status ➔ Completed

Trial completion • CNS Disorders • Movement Disorders • Parkinson's Disease

A Study to Evaluate in Patients With Parkinsonian Type Disorders (clinicaltrials.gov) - P2 | N=24 | Active, not recruiting | Sponsor: Chase Therapeutics Corporation | Unknown status ➔ Active, not recruiting | Trial completion date: Mar 2020 ➔ Dec 2023 | Trial primary completion date: Dec 2019 ➔ Dec 2023

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • 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

P2B001 in the management of untreated PD. Results from a randomized, double-blind, double-dummy controlled trial (MDS Congress 2022) - "Objective: Evaluate the efficacy and safety of P2B001 compared with its components and with Extended-Release pramipexole (ER-PPX, calibration arm) in untreated PD... The study met its primary and secondary efficacy endpoint and treatment was well-tolerated with fewer dopaminergic AEs than ER-PPX. These findings support the potential of P2B001 as a first-line, once-daily treatment for people with early PD that may offer effective symptomatic control with a favorable safety profile and no need for titration."

Clinical • CNS Disorders

Efficacy and safety of P2B001 in the management of early Parkinson’s disease. Results from a phase 3, randomized, double-blind, doubledummy controlled trial (AAN 2022) - "Objective: Evaluate the efficacy and safety of P2B001 compared with its components and with generic Extended-Release pramipexole (ER-PPX, calibration arm) in early Parkinson’s disease (PD)... The study met its primary and secondary endpoint and treatment was well-tolerated with fewer dopaminergic AEs than ER-PPX. These findings support the potential of P2B001 as a first-line, once-daily treatment for people with early PD that offers effective symptomatic control with a favorable safety profile and no need for titration."

Clinical • Late-breaking abstract • P3 data • CNS Disorders • Hypotension • Movement Disorders • Parkinson's Disease

P2B001 (Extended Release Pramipexole and Rasagiline): A New Treatment Option in Development for Parkinson's Disease. (PubMed, Adv Ther) - "In this drug evaluation, we review the preclinical and current clinical data for P2B001 and its components. The P2B001 combination has the potential to provide greater efficacy than either pramipexole or rasagiline alone and a better tolerability profile compared to higher dosage dopamine agonist monotherapy, while maintaining the advantage of lower motor complication risk than levodopa."

Journal • CNS Disorders • Movement 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

A Phase 3 Study With P2B001 in Subjects With Early Parkinson's (clinicaltrials.gov) - P3; N=525; Active, not recruiting; Sponsor: Pharma Two B Ltd.; Recruiting ➔ Active, not recruiting

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

A Phase 3 Study With P2B001 in Subjects With Early Parkinson's (clinicaltrials.gov) - P3; N=525; Recruiting; Sponsor: Pharma Two B Ltd.; Trial completion date: Feb 2021 ➔ Oct 2021; Trial primary completion date: Dec 2020 ➔ Aug 2021

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

Changes in Pramipexole Utilization after Introduction of the Extended-Release Formulation: A Nationwide Study in Taiwan. (PubMed, Drugs Real World Outcomes) - "Introduction of pramipexole ER to Taiwan resulted in higher LEDD in prescriptions with pramipexole. Patients with Parkinson's disease who were initiated on pramipexole ER had better adherence to the medication than those who were prescribed pramipexole IR."

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

Classics in Chemical Neuroscience: Pramipexole. (PubMed, ACS Chem Neurosci) - "Pramipexole was first manufactured by Pharmacia and Upjohn in July 1997 under the US brand names of Mirapex® and Mirapex ER®...Restless leg syndrome is a neurologic sensorimotor disorder characterized by a compelling urge to move the body/limb to relieve the uncomfortable sensation. In this Review, we will discuss the synthesis, drug metabolism, pharmacology, adverse effects, history, and the importance of pramipexole to neuroscience and describe its role in therapy."

Journal • CNS Disorders • Depression • Movement Disorders • Parkinson's Disease • Psychiatry • Restless Legs Syndrome

Pramipexole for the treatment of early Parkinson's disease (Expert Rev Neurother) - Risk-benefit ratio of pramipexole and other dopamine agonists in the treatment of early PD and its health-related quality of life in PD are reviewed

Review • Parkinson's Disease

Influence of Pramipexole on the QT Interval of the ECG in Healthy Male and Female Volunteers (clinicaltrials.gov) - P1; N=60; Completed; Sponsor: Boehringer Ingelheim

New P1 trial • Biosimilar

Patient considerations in early management of Parkinson's disease: Focus on extended-release pramipexole (Patient Prefer Adherence) - This article reviews the role of an extended-release formulation of pramipexole in the treatment of Parkinson's disease at an early stage; The once-daily extended-release formulation of pramipexole offers the advantages of easy continuous delivery of drug & convenience to pts, particularly early in the disease when monotherapy is the rule

Review • Parkinson's Disease

Pharmacokinetic evaluation of pramipexole (Expert Opin Drug Metab Toxicol) - Pramipexole has a very low affinity for serotoninergic 5-HT2A and 5-HT2B receptors, as well as D1-type receptors; Article summarizes the overall pharmacokinetic profile of pramipexole for both the IR and ER formulations

Review • Parkinson's Disease

Budget Impact Analysis of Pramipexole Extended Release Monotherapy In Early Parkinson'S Disease. (PubMed) - Value Health - No abstract available.

Journal • Biosimilar • Parkinson's Disease