Acorda Data on Inhaled Levodopa Therapy CVT-301
Recognized in Blue Ribbon Highlights Session at
International Congress of Parkinson's Disease and
ARDSLEY, N.Y.--(BUSINESS WIRE)-- Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that data from aPhase 2b clinical trial of CVT-301, an inhaled levodopa (L-dopa) under development for the episodic treatment ofOFF episodes associated with Parkinson's disease (PD), was included in the Blue Ribbon Highlights Session of the19th International Congress of Parkinson's Disease and Movement Disorders (MDS). Selected by a panel of experts,the Blue Ribbon Highlights Session provided a critical review of the best poster presentations, highlightingrelevance, novelty and quality of both clinical data and basic research. "Inhaled Levodopa (CVT-301) Provides RapidImprovement of OFF States in Parkinson's Disease" was one of only 19 posters selected from among the almost1,500 poster presentations at this year's conference.
OFF episodes are characterized by a re-emergence of PD motor symptoms, such as impaired ability to move,muscle stiffness and tremor. The trial showed that patients experiencing an OFF episode, treated with CVT-301,showed significantly greater improvements in motor function than patients treated with inhaled placebo; thedifference in improvement were already apparent 10 minutes after dosing and were durable for at least an hour,the longest time point at which they were measured.
"As their condition progresses, the majority of people with Parkinson's disease will experience OFF episodes whileusing oral levodopa, which is the gold standard of care," said Enrique Carrazana, M.D., Chief Medical Officer ofAcorda. "In clinical trials, CVT-301 has demonstrated the potential to reduce the duration of OFF episodes in peopletaking oral L-dopa. Improvements in motor function could be seen within 10 minutes of administration. We haveinitiated a Phase 3 trial to further develop this promising therapy, so that it can potentially benefit people withParkinson's who need new and effective treatment options for OFF episodes."
The poster was also chosen by the MDS Congress Scientific Program Chairs for a Guided Poster Tour Presentation.
Safety and Efficacy Finding
The primary endpoint of the Phase 2b trial was defined as the mean change from baseline in Unified Parkinson'sDisease Rating Scale Part 3 (UPDRS III) score after 4 weeks of treatment (10-60 minutes post dose). UPDRS III is anestablished scale to monitor PD motor impairment, and is considered a standard in the field.
In this study, participants receiving CVT-301 showed a statistically significant and clinically important reduction inaverage UPDRS III motor score compared to placebo (p<0.01) across all measured time points beginning at 10 andup to 60 minutes post-administration (p < 0.05). Both doses of CVT-301 were well tolerated, with no increaserelative to placebo in troublesome or non-troublesome dyskinesias during ON periods. There were no seriousadverse events reported in the drug group, and the incidence of drug-related adverse events was similar betweentreatment groups. The most common adverse events were dizziness, headache and cough; there were no adverseevents on cardiovascular or lung function. PD patients were able to self-administer treatment while in an OFF state.
About CVT-301 Phase 3 Program
Based on the results of the Phase 2b trial, Acorda has initiated a Phase 3 clinical trial that is expected to enrollapproximately 345 participants across three arms: 50mg, 35mg, or placebo. These are the same doses used in thePhase 2b study. The primary outcome measure is improvement on the UPDRS III after administration of CVT-301.
More details about the study, including enrollment criteria, can be
About Acorda Therapeutics
Founded in 1995, cused on developing therapies that restorefunction and improve the lives of people with neurological disorders.
Acorda markets three FDA-approvExtended Release Tablets, 10mg. The Company has one of the leading pipelines in the industry of novel neurological therapies. Acorda iscurrently developing a number of clinical and preclinical stage therapies. This pipeline addresses a range ofdisorders including post-stroke walking deficits, Parkinson's disease, epilepsy, neuropathic pain, heart failure, MSand spinal cord injury.
For more information, pleas
Forward Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities LitigationReform Act of 1995. 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 anduncertainties that could cause actual results to differ materially, including the ability to realize the benefitsanticipated from the Civitas transaction and to successfully integrate Civitas' operations into our operations; ourability to successfully market and sell Ampyra in the U.S.; third party payers (including governmental agencies) maynot reimburse for the use of Ampyra or our other products at acceptable rates or at all and may impose restrictiveprior authorization requirements that limit or block prescriptions; the risk of unfavorable results from futurestudies of Ampyra or from our other research and development programs, including CVT-301, Plumiaz, or any otheracquired or in-licensed programs; we may not be able to complete development of, obtain regulatory approval for,or successfully market CVT-301, Plumiaz, or any other products under development; we may need to raiseadditional funds to finance our expanded operations and may not be able to do so on acceptable terms; theoccurrence of adverse safety events with our products; delays in obtaining or failure to obtain regulatory approvalof or to successfully market Fampyra outside of the U.S. and our dependence on our collaboration partner Biogenin connection therewith; competition; failure to protect our intellectual property, to defend against the intellectualproperty claims of others or to obtain third party intellectual property licenses needed for the commercialization ofour products; and, failure to comply with regulatory requirements could result in adverse action by regulatoryagencies.
These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities andExchange Commission. Acorda may not actually achieve the goals or plans described in its forward-lookingstatements, and investors should not place undue reliance on these statements. Forward-looking statements madein this release are made only as of the date hereof, and Acorda disclaims any intent or obligation to update anyforward-looking statements as a result of developments occurring after the date of this release.
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Source: Acorda Therapeutics
Jeff Macdonald, 914-326-5232
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