ARDSLEY, NY, USA I June 29, 2017 I Acorda Therapeutics, Inc. (NASDAQ: ACOR) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for INBRIJATM (CVT-301, levodopa inhalation powder). Acorda is developing INBRIJA as a treatment for symptoms of OFF periods in people with Parkinson’s taking a carbidopa / levodopa regimen. OFF periods refer to the re-emergence of Parkinson’s symptoms. The trade name for CVT-301, INBRIJA, has been conditionally accepted by the FDA.
The NDA was submitted as a 505(b)(2) application. Based on current guidelines, the Company anticipates the FDA to inform Acorda by the end of September if the submission has been deemed complete and permits a full review.
“There is a tremendous need for new treatment options for OFF periods, which are regularly cited by people with Parkinson’s as one of the most problematic aspects of their disease,” said Burkhard Blank, M.D., Chief Medical Officer of Acorda. “On behalf of the Parkinson’s community, we are pleased to submit this promising therapy for FDA review.”
The NDA for INBRIJA includes data from a Phase 3 safety and efficacy study (SPAN-PD), as well as results from two ongoing long-term safety studies in people with Parkinson’s. Findings from these studies support the filing of INBRIJA for use on an as needed basis to address symptoms of OFF periods. Data from the SPAN-PD trial were presented as a late-breaking poster at the International Congress of Parkinson’s Disease and Movement Disorders (MDS) in June 2017.
The Company plans to file a Marketing Authorization Application (MAA) in Europe for CVT-301 by the end of 2017.
About Parkinson’s disease and OFF periods
Approximately one million people in the U.S. and 1.2 million Europeans are diagnosed with Parkinson’s disease (PD); OFF periods are experienced by approximately 350,000 in the U.S. and 420,000 in Europe.
Parkinson’s is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons responsible for producing dopamine. It causes a range of symptoms including impaired movement, muscle stiffness and tremors. As PD progresses, people with Parkinson’s experience OFF periods, which are characterized by the re-emergence of PD symptoms. This re-emergence can occur even when an individual’s treatment regimen has been optimized.
OFF periods can be very disruptive to the lives of people with Parkinson’s, their families and caregivers. OFF periods can increase in frequency and severity during the course of the disease.
About INBRIJATM (levodopa inhalation powder) and ARCUS®
INBRIJA (CVT-301) 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. The proprietary name INBRIJA has been conditionally accepted by the U.S. Food and Drug Administration (FDA).
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 to 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.
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 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.
SOURCE: Acorda Therapeutics
Post Views: 102
ARDSLEY, NY, USA I June 29, 2017 I Acorda Therapeutics, Inc. (NASDAQ: ACOR) has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for INBRIJATM (CVT-301, levodopa inhalation powder). Acorda is developing INBRIJA as a treatment for symptoms of OFF periods in people with Parkinson’s taking a carbidopa / levodopa regimen. OFF periods refer to the re-emergence of Parkinson’s symptoms. The trade name for CVT-301, INBRIJA, has been conditionally accepted by the FDA.
The NDA was submitted as a 505(b)(2) application. Based on current guidelines, the Company anticipates the FDA to inform Acorda by the end of September if the submission has been deemed complete and permits a full review.
“There is a tremendous need for new treatment options for OFF periods, which are regularly cited by people with Parkinson’s as one of the most problematic aspects of their disease,” said Burkhard Blank, M.D., Chief Medical Officer of Acorda. “On behalf of the Parkinson’s community, we are pleased to submit this promising therapy for FDA review.”
The NDA for INBRIJA includes data from a Phase 3 safety and efficacy study (SPAN-PD), as well as results from two ongoing long-term safety studies in people with Parkinson’s. Findings from these studies support the filing of INBRIJA for use on an as needed basis to address symptoms of OFF periods. Data from the SPAN-PD trial were presented as a late-breaking poster at the International Congress of Parkinson’s Disease and Movement Disorders (MDS) in June 2017.
The Company plans to file a Marketing Authorization Application (MAA) in Europe for CVT-301 by the end of 2017.
About Parkinson’s disease and OFF periods
Approximately one million people in the U.S. and 1.2 million Europeans are diagnosed with Parkinson’s disease (PD); OFF periods are experienced by approximately 350,000 in the U.S. and 420,000 in Europe.
Parkinson’s is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons responsible for producing dopamine. It causes a range of symptoms including impaired movement, muscle stiffness and tremors. As PD progresses, people with Parkinson’s experience OFF periods, which are characterized by the re-emergence of PD symptoms. This re-emergence can occur even when an individual’s treatment regimen has been optimized.
OFF periods can be very disruptive to the lives of people with Parkinson’s, their families and caregivers. OFF periods can increase in frequency and severity during the course of the disease.
About INBRIJATM (levodopa inhalation powder) and ARCUS®
INBRIJA (CVT-301) 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. The proprietary name INBRIJA has been conditionally accepted by the U.S. Food and Drug Administration (FDA).
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 to 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.
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 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.
SOURCE: Acorda Therapeutics
Post Views: 102
