Acorda to Present Data for INBRIJA™ (levodopa inhalation powder) at 2nd Pan American Parkinson’s Disease and Movement Disorders Congress
The INBRIJA posters will be presented on Saturday, June 23, 2018, as part of Parkinson’s Disease: Clinical Trials, Pharmacology and Treatment poster session from 1:00 PM - 2:30 PM. Posters will be available for viewing from 9:00 AM to 5:00 PM. Details are as follows:
- Abstract #189: Long-term Efficacy of Inhaled Levodopa in Parkinson’s Disease Subjects with Motor Fluctuations: a Phase 3 Open-Label Randomized Study
- Abstract #190: Long-Term Pulmonary Safety of Inhaled Levodopa in Parkinson’s Disease Subjects with Motor Fluctuations: a Phase 3 Open-Label Randomized Study
- Abstract #191: Inhaled Levodopa Administered With Oral Carbidopa/Levodopa for Early Morning OFF Symptoms in Patients with Parkinson’s Disease: Safety Assessment
- Abstract #192: Inhaled Levodopa Administered With Oral Carbidopa/Levodopa for Early Morning OFF Symptoms in Patients with Parkinson’s Disease: Exploratory Efficacy Analysis
These data were previously presented at the American Academy of Neurology Annual Meeting in April 2018, and included in a New Drug Application for INBRIJA that was accepted for review by U.S. Food and Drug Administration in February 2018. FDA has set a target PDUFA date of October 5, 2018.
Acorda will also host a Corporate Therapeutics Symposium on Saturday, June 23, 2018, from 12:15 PM – 1:15 PM ET. The symposium, titled Live Well Do Tell: Taking the Next Step in the Management of Parkinson’s Disease, will feature a panel of distinguished clinicians, including Rajesh Pahwah, MD (panel chair), Connie Marras, MD, PhD and Cynthia Comella, MD, PhD.
About Parkinson’s and OFF periods
Parkinson’s is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons responsible for producing dopamine. Approximately one million people in the U.S. and 1.2 million Europeans are diagnosed with Parkinson’s; OFF periods are experienced by approximately 350,000 in the U.S. and 420,000 in Europe. It causes a range of symptoms including impaired movement, muscle stiffness and tremors. As Parkinson’s progresses, people will experience OFF periods, which are characterized by the re-emergence of Parkinson’s motor and non-motor symptoms. This re-emergence can occur even when an individual’s treatment regimen has been optimized.
About INBRIJA™ (levodopa inhalation powder) and ARCUS®
INBRIJA is a self-administered, orally inhaled levodopa (L-dopa) therapy in development for the treatment of symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen.
INBRIJA utilizes Acorda’s investigational ARCUS® platform for inhaled therapeutics. INBRIJA was designed to deliver a precise dose of a dry powder formulation of L-dopa through the lung. Oral medication can be associated with variable onset of action, as the medicine is absorbed through the gastrointestinal (digestive) tract before reaching the brain. Inhaled treatments enter the body through the lungs and reach the brain, bypassing the digestive system.
The proprietary name INBRIJA has been conditionally accepted by the U.S. Food and Drug Administration (FDA).
About Acorda Therapeutics
Founded in 1995, Acorda Therapeutics is a biopharmaceutical company focused on developing therapies that restore function and improve the lives of people with neurological disorders. Acorda has a pipeline of novel neurological therapies addressing a range of disorders, including Parkinson’s disease and multiple sclerosis. Acorda markets two FDA-approved therapies, including AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.
This press release includes forward-looking statements. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including: the ability to realize the benefits anticipated from acquisitions, among other reasons because acquired development programs are generally subject to all the risks inherent in the drug development process and our knowledge of the risks specifically relevant to acquired programs generally improves over time; we may need to raise additional funds to finance our operations and may not be able to do so on acceptable terms; our ability to successfully market and sell Ampyra (dalfampridine) Extended Release Tablets, 10 mg in the U.S., which will likely be materially adversely affected by the March 2017 court decision in our litigation against filers of Abbreviated New Drug Applications to market generic versions of Ampyra in the U.S.; the risk of unfavorable results from future studies of Inbrija (levodopa inhalation powder) or from our other research and development programs, or any other acquired or in-licensed programs; we may not be able to complete development of, obtain regulatory approval for, or successfully market Inbrija or any other products under development; risks associated with complex, regulated manufacturing processes for pharmaceuticals, which could affect whether we have sufficient commercial supply of Inbrija to meet market demand, if it receives regulatory approval; third party payers (including governmental agencies) may not reimburse for the use of Ampyra, Inbrija or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; the occurrence of adverse safety events with our products; the outcome (by judgment or settlement) and costs of legal, administrative or regulatory proceedings, investigations or inspections, including, without limitation, collective, representative or class action litigation; competition; failure to protect our intellectual property, to defend against the intellectual property claims of others or to obtain third party intellectual property licenses needed for the commercialization of our products; and failure to comply with regulatory requirements could result in adverse action by regulatory agencies.
These and other risks are described in greater detail in our filings with the Securities and Exchange Commission. We may not actually achieve the goals or plans described in our forward-looking statements, and investors should not place undue reliance on these statements. Forward-looking statements made in this press release are made only as of the date hereof, and we disclaim any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
Acorda Therapeutics, Inc.
Felicia Vonella, 914-326-5146
Source: Acorda Therapeutics, Inc.