Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it has launched a new INBRIJA (levodopa inhalation powder) website and brand campaign. The campaign, “For the Fighters,” is based on direct feedback from people with Parkinson’s (PwPs). It honors the fighting spirit of the Parkinson’s community, encouraging PwPs to step up their fight by considering whether an on-demand treatment for OFF periods, such as INBRIJA, is right for them.
The campaign can be viewed at www.Inbrija.com.
INBRIJA is an inhaled prescription levodopa medicine used to treat the return of Parkinson’s symptoms (known as OFF episodes) in people with Parkinson’s disease who are treated with carbidopa-levodopa medicines. It does not replace the regular carbidopa-levodopa medicines. INBRIJA is not to be used by people who have taken a nonselective monoamine oxidase inhibitor, such as phenelzine or tranylcypromine, within the last 2 weeks.
“Our message to our Parkinson’s community is ‘we see you, and we see fighters.’ We want this campaign to reflect the strength, the determination, and grit that people with Parkinson’s bring to their fight against this disease,” said Kerry Clem, Chief Commercial Officer at Acorda. “We’ve heard from many people living with Parkinson’s, as well as their care partners, that when their symptoms return between doses of their regular medication it can cause them to avoid going out or making plans, and they may miss some of the important moments in their lives. Therefore, it’s important for people with Parkinson’s to have access to on-demand treatment options, such as INBRIJA, to address these OFF periods when and where they occur*.”
“We’re proud to be able to bring an on-demand, rescue treatment to PwPs to help address OFF periods,” said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. “In addition, now that there are fewer on-demand therapies available, we are redoubling our efforts to provide this community with education and support, so that people living with Parkinson’s can continue their fight. These efforts are building on the success of the INBRIJA commercial that we launched this spring.”
Jimmy Gaddis, one of Acorda’s Inbrija ambassadors, added: “I’ve lived with Parkinson’s for over 16 years, so this message really hits home for me. I’m determined to make every day, every moment, count, and to live a full life with my family and friends. I look for whatever tools or options will help me in this fight, whether it’s exercise, healthy eating, social activities, or on-demand treatment options.”
Additional Important Safety Information
Before using INBRIJA, tell your healthcare provider about your 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 unknown if INBRIJA will harm an unborn baby.
- breastfeeding or plans to breastfeed. Levodopa can pass into breastmilk and it is unknown if it can harm the baby.
Tell your healthcare provider if you take:
- MAO-B inhibitors
- dopamine (D2) antagonists (including phenothiazines, butyrophenones, risperidone, metoclopramide)
- iron salts or multivitamins that contain iron salts
Do not drive, operate machinery, or do other activities until you know how INBRIJA affects you. Sleepiness and falling asleep suddenly can happen as late as a year after treatment is started.
Tell your healthcare provider if you experience the following side effects:
- falling asleep during normal daily activities with or without warning. If you become drowsy, do not drive or do activities where you need to be alert. Chances of falling asleep during normal activities increases if you take medicine that causes sleepiness.
- withdrawal-emergent hyperpyrexia and confusion (fever, stiff muscles, or changes in breathing and heartbeat) if you suddenly stop using INBRIJA or carbidopa/levodopa, or suddenly lower your dose of carbidopa/levodopa.
- low blood pressure when standing up (that may be with dizziness, fainting, nausea, and sweating). Get up slowly after sitting/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 you; 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 this occurs, stop taking INBRIJA and seek immediate medical attention.
- increased eye pressure in patients with glaucoma. Your healthcare provider should monitor this.
- changes in certain lab values including liver tests
The most common side effects of INBRIJA are cough, upper respiratory tract infection, nausea, and change in the color of saliva or spit.
Do not orally inhale more than 1 dose (2 capsules) for any OFF period. Do not take more than 5 doses (10 capsules) in a day.
Please see Full Prescribing Information here.
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.
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 INBRIJA, AMPYRA 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; the reverse stock split and its impact on 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.