In the United States, approximately 350,000 people with Parkinson's experience OFF periods.About CVT-301 / Phase 3 Program CVT-301 is an investigational agent being developed as a self-administered, inhaled levodopa (L-dopa) therapy for the treatment of OFF periods in Parkinson's disease. It is intended for use as an adjunctive therapy to a patient's individually optimized oral L-dopa/carbidopa regimen. CVT-301 utilizes Acorda's ARCUS ® platform for inhaled therapeutics, which delivers a precise dose of a dry powder formulation of L-dopa to the lung. Oral medication can be associated with slow and variable onset of action, as the medicine is absorbed through the gastrointestinal (digestive) tract before reaching the brain. Inhaled treatments, such as those that utilize our ARCUS technology, enter the body through the lungs and reach the brain shortly thereafter, bypassing the digestive system. Based on the successful results of two Phase 2 trials, Acorda initiated a Phase 3 clinical program that includes a safety and efficacy study as well as general and special population safety studies. The efficacy trial has enrolled approximately 345 participants across three arms: 50mg, 35mg, or placebo. These are the same doses used in the Phase 2b study. The primary outcome measure is improvement on the Unified Parkinson's Disease Rating Scale Part 3 (UPDRS III) after administration of CVT-301 in patients experiencing an OFF period (30 minutes post dose). UPDRS III is an established scale to monitor PD motor impairment, and is considered a standard in the field. The Company expects to announce results from this study in Q1 2017. Early CVT-301 clinical studies were funded in part by grants from The Michael J. Fox Foundation for Parkinson's Research. About Acorda Therapeutics Founded in 1995, Acorda Therapeutics is a biotechnology 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, post-stroke walking difficulties (PSWD), migraine, and multiple sclerosis. Acorda markets three FDA-approved therapies, including AMPYRA ® (dalfampridine) Extended Release Tablets, 10 mg. For more information, please visit the Company's website at: www.acorda.com. Forward-Looking Statement 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 complete the Biotie transaction on a timely basis; the ability to realize the benefits anticipated from the Biotie and Civitas transactions, 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; the ability to successfully integrate Biotie's operations and Civitas' operations, respectively, into our operations; we may need to raise additional funds to finance our expanded 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.; third party payers (including governmental agencies) may not reimburse for the use of Ampyra or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; the risk of unfavorable results from future studies of Ampyra or from our other research and development programs, including CVT-301 or any other acquired or in-licensed programs; we may not be able to complete development of, obtain regulatory approval for, or successfully market CVT-301, any other products under development, or the products that we will acquire when we complete the Biotie transaction; the occurrence of adverse safety events with our products; delays in obtaining or failure to obtain and maintain regulatory approval of or to successfully market Fampyra outside of the U.S. and our dependence on our collaborator Biogen in connection therewith; 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 presentation 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 presentation.1 Lipp MM et al. Preclinical and clinical assessment of inhaled levodopa for OFF episodes in Parkinson's disease. Sci. Transl. Med. 8, 360ra136 (2016) [Online version]. 2 LeWitt PA et al. Randomized Trial of Inhaled Levodopa (CVT-301) for Motor Fluctuations in Parkinson's Disease. Movement Disorders 2016; 31(9): 1356-1365