Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it will present data on INBRIJA (levodopa inhalation powder) and OFF Periods at the American Academy of Neurology (AAN) Annual Meeting, taking place in Boston from April 22 to April 27, 2023.
The poster, “Subgroup Analyses of Effect of Treatment With Levodopa Inhalation Powder (CVT-301) 84 mg by Severity of OFF Symptoms in People With Parkinson’s Disease, as Assessed by the Unified Parkinson’s Disease Rating Scale Part III (UPDRS-III),” will be presented on Tuesday, April 25.
DATE and TIME: Tuesday, April 25, 11:45AM – 12:45PM
LOCATION: Poster #017 in Neighborhood 11
SESSION: P8 Movement Disorders: Atypical Parkinsonisms 1
A virtual poster hall will be available on the AAN’s virtual platform during the duration of the meeting and through May 15, 2023.
About Acorda Therapeutics
Acorda Therapeutics develops therapies to restore function and improve the lives of people with neurological disorders. INBRIJA® is approved for intermittent treatment of OFF episodes in adults with Parkinson’s disease treated with carbidopa/levodopa. INBRIJA is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks. INBRIJA utilizes Acorda’s innovative ARCUS® pulmonary delivery system, a technology platform designed to deliver medication through inhalation. Acorda also markets the branded AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.
About INBRIJA (levodopa inhalation powder)
INBRIJA is the first and only inhaled levodopa. It is a prescription medicine used for the return of Parkinson’s symptoms (known as OFF episodes) in adults treated with carbidopa/levodopa medicine. INBRIJA does not replace regular carbidopa/levodopa medicine. INBRIJA is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last two weeks. INBRIJA utilizes Acorda’s innovative ARCUS platform for inhaled therapeutics.
Additional Important Safety Information (U.S.)
Before using INBRIJA, patients should tell their healthcare provider about all their medical conditions, including:
- asthma, chronic obstructive pulmonary disease (COPD), or any chronic lung disease
- daytime sleepiness, sleep disorders, sleepiness/drowsiness without warning, or use of medicine that increases sleepiness including antidepressants or antipsychotics
- dizziness, nausea, sweating, or fainting when standing up
- abnormal movement (dyskinesia)
- mental health problems such as hallucinations or psychosis
- uncontrollable urges like gambling, sexual urges, spending money, or binge eating
- pregnancy or plans to become pregnant. It is not known if INBRIJA will harm an unborn baby.
- breastfeeding or plans to breastfeed. Levodopa (the medicine in INBRIJA) can pass into breastmilk and it is unknown if it can harm the baby.
Patients should tell their healthcare provider if they take:
- MAO-B inhibitors
- dopamine D2 receptor antagonists (including phenothiazines, butyrophenones, risperidone, metoclopramide)
- iron salts or multivitamins that contain iron salts
Patients are not to drive, operate machinery, or do other activities until they know how INBRIJA affects them. Sleepiness and falling asleep suddenly can happen as late as a year after treatment is started.
Patients should tell their healthcare provider if they experience the following side effects:
- falling asleep during normal daily activities with or without warning. If patients become drowsy, they should not drive or do activities where they need to be alert. Chances of falling asleep during normal activities increases if patients take medicine that cause sleepiness.
- withdrawal-emergent hyperpyrexia and confusion (fever, stiff muscles, or changes in breathing and heartbeat) if patients suddenly stop using INBRIJA or carbidopa/levodopa medicines, or suddenly lower their dose of carbidopa/levodopa.
- low blood pressure when standing up (that may be with dizziness, fainting, nausea, and sweating). Patients should get up slowly after sitting or lying down.
- hallucinations and other psychosis – INBRIJA may cause or worsen seeing/hearing/believing things that are not real; confusion, disorientation, or disorganized thinking; trouble sleeping; dreaming a lot; being overly suspicious or feeling people want to harm them; acting aggressive, and feeling agitated/restless.
- unusual uncontrollable urges such as gambling, binge eating, shopping, and sexual urges has occurred in some people using medicine like INBRIJA.
- uncontrolled, sudden body movements (dyskinesia) may be caused or worsened by INBRIJA. INBRIJA may need to be stopped or other Parkinson’s medicines may need to be changed.
- bronchospasm – people with asthma, COPD, or other lung diseases may wheeze or have difficulty breathing after inhaling INBRIJA. If patients have these symptoms, they should stop taking INBRIJA and seek immediate medical attention.
- increased eye pressure in patients with glaucoma. Healthcare providers should monitor this.
- changes in certain lab values including liver tests.
The most common side effects of INBRIJA include cough, upper respiratory tract infection, nausea, and change in the color of saliva or spit.
No more than 1 dose (2 capsules) should be inhaled for any OFF period. No more than 5 doses (10 capsules) of INBRIJA should be used in a day.
Please see the accompanying Full Prescribing Information available at www.INBRIJA.com/prescribing-information.PDF.
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: we may not be able to successfully market AMPYRA, INBRIJA or any other products under development; the COVID-19 pandemic, including related restrictions on in-person interactions and travel, and the potential for illness, quarantines and vaccine mandates affecting our management, employees or consultants or those that work for other companies we rely upon, could have a material adverse effect on our business operations or product sales; our ability to attract and retain key management and other personnel, or maintain access to expert advisors; our ability to raise additional funds to finance our operations, repay outstanding indebtedness or satisfy other obligations, and our ability to control our costs or reduce planned expenditures; risks associated with the trading of our common stock; risks related to the successful implementation of our business plan, including the accuracy of its key assumptions; risks related to our corporate restructurings, including our ability to outsource certain operations, realize expected cost savings and maintain the workforce needed for continued operations; risks associated with complex, regulated manufacturing processes for pharmaceuticals, which could affect whether we have sufficient commercial supply of INBRIJA or AMPYRA to meet market demand; our reliance on third-party manufacturers for the timely production of commercial supplies of INBRIJA and AMPYRA; third-party payers (including governmental agencies) may not reimburse for the use of INBRIJA or AMPYRA at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; reliance on collaborators and distributors to commercialize INBRIJA and AMPYRA outside the U.S.; our ability to satisfy our obligations to distributors and collaboration partners outside the U.S. relating to commercialization and supply of INBRIJA and AMPYRA; competition for INBRIJA and AMPYRA, including increasing competition and accompanying loss of revenues in the U.S. from generic versions of AMPYRA (dalfampridine) following our loss of patent exclusivity; the ability to realize the benefits anticipated from acquisitions because, among other reasons, 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 risk of unfavorable results from future studies of INBRIJA (levodopa inhalation powder) or from other research and development programs, or any other acquired or in-licensed programs; 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; 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, except as may be required by law.