Breaking News
October 17, 2018 - Network of doctors identify the cause of 31 new conditions
October 17, 2018 - Notable improvement in brain cancer survival among younger patients but not much for elderly
October 17, 2018 - Scientists shed light on roles of transcription factors, TP63 and SOX2, in squamous cell carcinoma
October 17, 2018 - Costs of Medicare Diabetes Prevention Program may be higher than expected reimbursement
October 17, 2018 - Misuse of prescription opioids or benzodiazepines associated with suicidal thoughts
October 17, 2018 - C-Section Rates Have Nearly Doubled Since 2000: Study
October 17, 2018 - Talking to Your Kids About STDs
October 17, 2018 - New classification of periodontal and peri-implant diseases and conditions
October 17, 2018 - Herbert D. Kleber, Pioneer in Addiction Treatment, Dies at 84
October 17, 2018 - Health effects of smoke-filled atmosphere
October 17, 2018 - Down syndrome may hold important clues to onset of Alzheimer’s disease
October 17, 2018 - A special report on US’ aging societies
October 17, 2018 - Birth mode may have acute effects on neurodevelopment, study suggests
October 17, 2018 - Global health innovation system fails to deliver affordable treatments to patients, says report
October 17, 2018 - Simple, inexpensive test quickly detects antibiotic-resistant ‘superbugs’
October 17, 2018 - New drugs could reduce risk of heart disease when added to statins
October 17, 2018 - Visible and valued: Stanford Medicine’s first-ever LGBTQ+ Forum
October 17, 2018 - HVP vaccination not linked with rise in teen risky sex
October 17, 2018 - Potential ‘early warning markers’ for sepsis discovered
October 17, 2018 - Who knew? Life begins (again) at 65
October 17, 2018 - Application of blood pressure guidelines ups treatment
October 17, 2018 - Stanford researchers find that small molecule may help treat enzyme deficiency
October 17, 2018 - Speed Cameras Save Money and Lives in New York City
October 17, 2018 - Men who conform to ‘the man box’ more likely to consider suicide and violence
October 17, 2018 - Researchers aim to create more authentic organoids for drug testing, transplantation
October 16, 2018 - New blood test for pediatric brain tumor patients offers safer approach than surgical biopsies
October 16, 2018 - Age-related estrogen increase may be the culprit behind inguinal hernias in men
October 16, 2018 - Skills-Based Intervention Did Not Cut Systolic BP After Stroke, TIA
October 16, 2018 - Researchers uncover new role of TIP60 protein in controlling tumour formation
October 16, 2018 - Behind the scenes of a lifesaving heart surgery
October 16, 2018 - ‘To See the Suffering’
October 16, 2018 - Drinking concentrated rosemary extract can boost memory by up to 15%, shows research
October 16, 2018 - Medicare Advantage riding high as new insurers flock to sell to seniors
October 16, 2018 - NHS tackles prescription fraud to save millions
October 16, 2018 - New molecular switch may help develop sophisticated photomedications
October 16, 2018 - Improving access to behavioral health screenings for pregnant and postpartum women
October 16, 2018 - Health Highlights: Oct. 12, 2018
October 16, 2018 - Study holds promise for new pediatric brain tumor treatment
October 16, 2018 - Patient advocate uses MRI scans to create art and spark conversations about life with illness
October 16, 2018 - Fish oil based diets may suppress growth and spread of breast cancer cells
October 16, 2018 - Number of VHA facilities offering acupuncture has increased rapidly
October 16, 2018 - Influential Leapfrog Group jumps in to rate 5,600 surgery centers
October 16, 2018 - HIV-infected infants more likely to acquire congenital cytomegalovirus infection
October 16, 2018 - Study pinpoints new marker that can predict Crohn’s disease subtype
October 16, 2018 - Simple procedure could be efficacious intervention for failed back surgery
October 16, 2018 - New research identifies modifiable dementia risk factor in elderly people
October 16, 2018 - Zebrafish study uncovers molecular ‘brake’ that helps control eye lens development
October 16, 2018 - Overlapping copy number variations underlie autism and schizophrenia in Japanese patients
October 16, 2018 - Early menopause and diabetes may reduce life expectancy
October 16, 2018 - Majority of Americans’ ancestry can be traced through existing DNA databases
October 16, 2018 - Patients coerced into mental health care less likely to perceive treatment as effective
October 16, 2018 - Healthy elders can consume walnuts without having negative impact on weight gain, finds study
October 16, 2018 - Interactive robot helps older people exercise and detects underlying health problems
October 16, 2018 - What you need to know about autism spectrum disorder
October 16, 2018 - Antidepressants can be used to treat Alzheimer’s disease
October 16, 2018 - Study uncovers important role of PRMT1 in dilated cardiomyopathy
October 16, 2018 - Nutritional quality of breakfast linked to cardiovascular and metabolic risk factors in children
October 16, 2018 - Study uses novel approach to investigate genetic origins of mental illnesses
October 16, 2018 - Scientists develop dual anthrax-plague vaccine
October 16, 2018 - Poor Outcomes for Hispanic Infants With Congenital Heart Dz
October 16, 2018 - Global study finds youngest in class more likely to be diagnosed with ADHD
October 16, 2018 - Researchers sequence two selfish genes in the fungus Neurospora intermedia
October 16, 2018 - Survey results highlight the need for better communication between patients and HCPs about bacterial vaginosis
October 16, 2018 - Researchers develop fibrin-targeting immunotherapy to protect against neurodegeneration
October 16, 2018 - Researchers create open access database on healthy immunity
October 16, 2018 - Rice University chemist wins big award to study small surfaces
October 16, 2018 - Study finds 43% drop in stroke rate
October 16, 2018 - Researchers identify basic relationships of cell cycle and cellular senescence in the placenta
October 16, 2018 - UA professor receives NSF grant to develop antifouling materials for medical implants
October 16, 2018 - Obesity Doubles Odds for Colon Cancer in Younger Women
October 16, 2018 - Adults with ADHD not constrained in creativity
October 16, 2018 - Raising visibility for people and students with chronic illness and disability
October 16, 2018 - Allele awarded NIH grant to develop nanoantibody therapies for treatment of sepsis
October 16, 2018 - Only 59% of young adults undergoing surgery are fluid responsive
October 16, 2018 - Research points to potential new treatment for hearing loss
October 16, 2018 - MDI Biological Laboratory receives $1.2 million SEPA grant to promote data literacy
October 16, 2018 - Vast majority of dementia cases may arise from spontaneous genetic errors
October 16, 2018 - New project aims to deliver fast, effective treatment for autoimmune rheumatic diseases
October 16, 2018 - Study identifies molecular switch that controls fate of milk-producing breast cells
October 16, 2018 - Research shows diet has little influence on precursor to gout
Acorda Discontinues Tozadenant Development Program

Acorda Discontinues Tozadenant Development Program

image_pdfDownload PDFimage_print

ARDSLEY, N.Y.–(BUSINESS WIRE)–November 20, 2017 — Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that it is discontinuing its clinical development program for tozadenant, an investigational treatment for Parkinson’s disease, including immediately discontinuing dosing of all participants currently enrolled in its tozadenant studies. The Company made this decision based on new information obtained from the Phase 3 program related to previously disclosed agranulocytosis and associated serious adverse events. After analyzing this additional information, the Company concluded that it could not be confident that weekly white blood cell count screening would sufficiently ensure patient safety. Acorda has informed regulatory authorities and trial investigators regarding the orderly closure of ongoing studies.

“Patient safety is our top priority,” said Ron Cohen, M.D., Acorda’s President and CEO. “While we are deeply disappointed by this outcome, we remain committed to the Parkinson’s community, which is in great need of new therapeutic options. We are grateful to the patients who volunteered for the tozadenant studies and to their care partners, clinical investigators, and the internal and external study teams.”

Over 90% of the participants in the placebo-controlled Phase 3 efficacy and safety study, CL-05, have completed the study. The Company expects data from these participants in the first quarter of 2018 and to present these at appropriate medical/scientific venues.

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 an industry-leading pipeline of novel neurological therapies addressing a range of disorders, including Parkinson’s disease, migraine and multiple sclerosis. Acorda markets two 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

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 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., which will likely be materially adversely affected by the recently announced court decision in our litigation against filers of Abbreviated New Drug Applications (each, an “ANDA”) to market generic versions of Ampyra 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.

Source: Acorda Therapeutics, Inc.

Posted: November 2017

Tagged with:

About author

Related Articles