Inbrija (levodopa inhalation powder) / Esteve, Biopas Group, Chance Pharma, Merz Pharma - LARVOL DELTA

Cost-Effectiveness Analysis of Inhaled Levodopa for Managing OFF Episodes in Patients With Parkinson's Disease (ISPOR-EU 2025) - "After discontinuing treatment, patients received a basket of subsequent therapies including apomorphine, levodopa-carbidopa intestinal gel and deep brain stimulation. The base-case results demonstrate inhaled levodopa is associated with 6.648 quality-adjusted life years (QALY), and £153,378 total costs. The cost-effectiveness analysis results, alongside the NMB, indicate inhaled levodopa could be a cost-saving alternative in the management of OFF episodes in PD patients for the UK population."

Clinical • Cost effectiveness • HEOR • CNS Disorders • Gastrointestinal Disorder • Movement Disorders • Parkinson's Disease

Comparative Efficacy Safety and Discontinuation of Inhaled Levodopa for Patients With Parkinson's Disease: A Network Meta-Analysis (ISPOR-EU 2025) - "Inhaled levodopa, APO-SC, and APO-SL have comparable efficacy in reduction in OFF time, change in UPDRS-III score, and improvement in PGI-C score. Although the AE rates are comparable, the probability of treatment discontinuation due to AEs is significantly higher for APO-SC compared to inhaled levodopa."

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

An In Vitro-In Vivo Comparison of Two Levodopa Dry Powder Products for Inhalation: A Randomized Trial Comparing Inbrija and Levodopa Cyclops. (PubMed, Pharmaceutics) - " This suggests that the systemic absorption of levodopa via the lungs is not limited by dissolution but most likely by its permeation rate. This finding underscores the need to critically apply in vitro tests and critically interpret the results for predicting the in vivo performance of inhaled products."

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

Opportunities for and Challenges of Pulmonary Drug Delivery in the Management of Acute Exacerbations of CNS Disorders. (PubMed, CNS Drugs) - "In this review, the potential of PM delivery to address this gap in the management of acute CNS disorders is critically assessed, focusing on Staccato® (loxapine) for agitation, Inbrija® (levodopa) for PD, the investigational drug inhaler device Staccato® (alprazolam) for epilepsy, and other investigational drug inhaler devices. In particular, for epilepsy, on-demand medication that may be administered by patients or caregivers early at seizure onset may translate to improved patient outcomes. To enhance PM management of acute exacerbations of CNS disorders, further research and user training for optimal PM administration are required."

Journal • Review • CNS Disorders • Epilepsy • Insomnia • Migraine • Movement Disorders • Pain • Parkinson's Disease • Sleep Disorder

The on-going quest for a long-acting oral form of levodopa. (PubMed, Expert Opin Drug Metab Toxicol) - "Among these new administration routes, inhaled levodopa and continuous subcutaneous foslevodopa/foscarbidopa stand out as the most studied and less invasive options. However, with adverse effects associated to each solution, it is important to find approaches that are adapted to each patient."

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

Overcoming Absorption Issues: Success with Inhaled Levodopa in a Gastrectomized PD Patient. (PubMed, Mov Disord Clin Pract) - No abstract available

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

Therapeutic effect of an inhaled levodopa dry powder formulation on off episodes in patients with Parkinson's disease. (PubMed, Ther Adv Neurol Disord) - "Now, it is registered in the OMON with the same identification number (NL6876, Effectiveness of inhaled levodopa in PD; Research with human participants (onderzoekmetmensen.nl)). All patients provided written informed consent."

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

InBrain Pharma to Present Positive Results from Its DIVE-I Phase I/II Clinical Trial for Parkinson’s Disease at the Congress of Parkinson’s Disease and Movement Disorders from September 27 to October 1 in Philadelphia (GlobeNewswire) - "InBrain Pharma...will present the positive results of its Phase I/II DIVE-I clinical trial for Parkinson’s disease at the upcoming International Congress of Parkinson’s Disease and Movement Disorders, held in Philadelphia from September 27 to October 1, 2024...'The clinical results are exceptional, showing a very good safety profile, and a remarkable clinical effect on controlling severe motor symptoms (walking and communication difficulties, involuntary movements, agitation), allowing for a reduction in the dosage of underlying oral treatments based on L-dopa, which often cause abnormal movements. Moreover, all our treated patients decided to continue the therapy'..."

P1/2 data • CNS Disorders • Parkinson's Disease

Novel In-Clinic Use of Levodopa Inhalation Powder (CVT-301) as an Outpatient Diagnostic Tool for Parkinson's Disease (MDS Congress 2024) - "At that same initial visit,L-dopa-responsive patients were prescribed oral Carbidopa/Levodopa & its effectiveness was evaluated at follow-up. Although inhaled levodopa CVT-301 was developed for "on-demand" treatment of sudden motor-OFF periods in PD,4 there is potential for the novel in-clinic use of this quick- acting dopaminergic drug as a tool to expedite the diagnosis of PD without any clinically significant adverse events."

Clinical • CNS Disorders • Essential Tremor • Pain • Parkinson's Disease

If Oral Levodopa is not Possible, Keep Calm and Breathe Deeply (MDS Congress 2024) - "Due to severe motor fluctuations and severe dysphagia episodes, it was decided to start levodopa/carbidopa intestinal gel infusion as advanced therapy. His treatment at that time was oral levodopa divided into 6 doses, safinamide, rivastigmine and, for delayed ON in the morning and for unpredictable OFF, inhaled levodopa had been prescribed. He had presented intolerance to opicapone, rasagiline and dopamine agonists, the latter with impulse control disorder and hallucinations at low doses... – Inhaled levodopa could be of choice in patients without tolerance to oral/enteral or transdermal treatments. – Future studies should provide more real-life data on this utility beyond the objective of clinical trials."

CNS Disorders • Pain • Parkinson's Disease

Measuring Motor Improvement with a Wearable Device in a Parkinson Disease Patient undergoing Subcutaneous Levodopa Carbidopa Infusion (MDS Congress 2024) - "Patient was monitored using STAT-ON™ to measure changes in motor symptoms across therapeutic interventions: transitioning from oral (V0) to apomorphine infusion (V1), to oral + inhaled levodopa (V2), and finally Duodopa SP® infusion (V3) . The motor state of PD patients can be objectively observed with STAT-ON. In this patient, Duodopa SP® therapy effect has been assessed. Duodopa DP® has shown to effectively control the symptoms, improving their time in OFF, ON, FoG, dyskinesia and Quality of Life."

Clinical • CNS Disorders • Dystonia • Parkinson's Disease

InBrain Pharma announces the publication of an article on the pharmacokinetic and pharmacodynamic limitations of L-DOPA in the management of Parkinson's disease in the Journal of Parkinson's Disease (GlobeNewswire) - "The article consists of a review of the existing literature on the limitations of L-DOPA, a mainstay in the treatment of Parkinson's disease, especially when used in the context of continuous dopaminergic stimulation, highlighting the need for new therapeutic avenues...After selecting the 10 most relevant articles in the literature, it is shown that pharmacokinetic and pharmacodynamic problems include: restricted digestive and cerebral passage, unnecessary peripheral distribution, short half-life, age- and Parkinson's disease-induced decline in central aromatic L-amino acid decarboxylase, poor distribution in many cells and pulsatile stimulation of dopaminergic receptors. Current L-DOPA based treatments beyond oral do not provide a satisfactory response to these limitations."

Clinical data • CNS Disorders • Parkinson's Disease

DPI-6: Usability of Levodopa Cyclops™ vs INBRIJA® in Parkinson's Patients (clinicaltrials.gov) - P=N/A | N=16 | Completed | Sponsor: Martini Hospital Groningen | Recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Jul 2024 | Trial primary completion date: Nov 2024 ➔ Jul 2024

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

Inhaled levodopa in fluctuating Parkinson´s disease: post-commercialization experience in a movement disorders Unit (EAN 2024) - "In our cohort, inhaled levodopa provided rapid and substantial improvement in our cohort and was overall well tolerated with a discontinuation rate of 11%."

CNS Disorders • Cough • Movement Disorders • Parkinson's Disease • Respiratory Diseases

Merz Therapeutics Closes $185M Asset Purchase Agreement with Acorda Therapeutics (Businesswire) - "Merz Therapeutics announces today the successful acquisition of INBRIJA (levodopa inhalation powder) and (F)AMPYRA (fampridine), and related assets from Acorda Therapeutics, Inc. AMPYRA (dalfampridine) is Food and Drug Administration (FDA) approved in the U.S. and commercialized as FAMPYRA in the European Union and other territories throughout the world. This transaction was conducted through a court-structured 363 sale under the U.S. Bankruptcy Code. The completion of this deal, valued at USD 185 million in cash, bolsters Merz Therapeutics’ market position by enhancing offerings for people living with Parkinson’s disease and expanding into the multiple sclerosis (MS) space."

M&A • CNS Disorders • Parkinson's Disease

Inhaled levodopa: from evidence to experience (PubMed, Rev Neurol) - "The choice for each patient will depend on their individual needs and circumstances. To mark the first year of the introduction of inhaled levodopa, we review these therapies, focusing on the experience with this new dosage form of levodopa."

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

DPI-6: Usability of Levodopa Cyclops™ vs INBRIJA® in Parkinson's Patients (clinicaltrials.gov) - P=N/A | N=16 | Recruiting | Sponsor: Martini Hospital Groningen | Not yet recruiting ➔ Recruiting

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

Dopamine and its precursor levodopa inactivate SARS-CoV-2 main protease by forming a quinoprotein. (PubMed, Free Radic Biol Med) - "CVT-301 (orally inhaled levodopa) was approved by the FDA as a drug for Parkinson's patients prior to the outbreak of COVID-19 in 2018. Based on the fact that SARS-CoV-2 causes inefficient replication in the CNS with abundant endogenous Mpro inhibitor in addition to the current finding that levodopa has an Mpro-inhibitory effect somewhat stronger than dopamine, we should urgently investigate the use of CVT-301 as a lung-targeting, COVID-19, Mpro inhibitor."

Journal • CNS Disorders • Infectious Disease • Movement Disorders • Novel Coronavirus Disease • Parkinson's Disease • Pulmonary Disease • Respiratory Diseases

Acorda Therapeutics and Merz Announce Signing of “Stalking Horse” Asset Purchase Agreement (Businesswire) - "Acorda Therapeutics, Inc...today announced that it has entered into an asset purchase agreement with Merz Therapeutics to purchase substantially all of the assets of Acorda, including the rights to INBRIJA, AMPYRA, and FAMPYRA for $185 million. Merz Therapeutics, a leader in the field of neurotoxins, is a business of the global family-owned company Merz, headquartered in Frankfurt am Main, Germany. To facilitate an orderly sale process, and in an effort to maximize the value for the Company's assets through a competitive auction process, with Merz serving as the 'stalking horse' bidder, Acorda and certain of its affiliates filed voluntary petitions to commence Chapter 11 proceedings in the U.S. Bankruptcy Court for the Southern District of New York."

M&A • CNS Disorders • Multiple Sclerosis • Parkinson's Disease

Hope vs. Hype III: Rescue/on-demand therapies are preferable to device-assisted therapies in Parkinson disease. (PubMed, Parkinsonism Relat Disord) - No abstract available

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

1101 Advanced Therapies in Parkinson’s Disease (MDS-PAS 2024) - "Review the implications of the latest clinical trials aiming to translate infusion therapies for patients with Parkinson’s disease with motor fluctuations refractory to optimization of oral therapies 3. Recognize new developments in advanced therapies (inhaled levodopa, sublingual apomorphine) and how to choose them for Parkinson’s disease patients Recommended Audience: Clinician / General Neurology, Fellow / Resident / Student, Health Professional (non-physician), Researcher / Basic Science"

Metastases • CNS Disorders • Parkinson's Disease

Novel In-Clinic Use of Levodopa Inhalation Powder (CVT-301) as a Outpatient Diagnostic Tool for Parkinson's Disease. (MDS-PAS 2024) - No abstract available

Clinical • CNS Disorders • Parkinson's Disease

Motor Network Physiology (clinicaltrials.gov) - P=N/A | N=120 | Recruiting | Sponsor: University of Texas Southwestern Medical Center | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

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

Acorda Therapeutics Announces Biopas Laboratories Submission to Regulatory Agencies in Six Latin American Countries for Approval of INBRIJA (Yahoo Finance) - "Acorda Therapeutics, Inc...today announced the submission of new regulatory filings for the approval of INBRIJA^® (levodopa inhalation powder) in six countries in Latin America by its partner Biopas Laboratories (Biopas)....'We are delighted that Biopas has submitted filings for the approval of INBRIJA in six countries in Latin America, with up to five approvals expected in 2024...'"

Non-US regulatory • CNS Disorders • Parkinson's Disease

DPI-6: Usability of Levodopa Cyclopsâ„¢ vs INBRIJA® in Parkinson's Patients (clinicaltrials.gov) - P=N/A | N=16 | Not yet recruiting | Sponsor: Martini Hospital Groningen | Trial completion date: Oct 2023 ➔ Dec 2024 | Trial primary completion date: Oct 2023 ➔ Nov 2024

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