Acorda Therapeutics, Inc. announced that The Lancet Neurology published results from SPAN-PD, the Phase 3 pivotal efficacy trial of INBRIJA (levodopa inhalation powder), also referred to as CVT-301. In the study, INBRIJA 84 mg significantly improvedmotor function at 30 minutes during OFF periods in people with Parkinson’s taking carbidopa/levodopa, the study’s primary endpoint. Onset of action was seen as early as 10 minutes and the reduction at 30 minutes was maintainedat 60 minutes. Multiple secondary endpoints were supportive of the primary endpoint. Data from the study were first presented at the 2017 International Congress of Parkinson’s Disease and Movement Disorders (MDS). About SPAN-PD (NCT02240030) and Key Results: The Phase 3 pivotal efficacy trial for INBRIJA – SPAN-PD – was a 12-week, randomized, placebo controlled, double blind study evaluating the effectiveness of INBRIJA versus placebo in patients with Parkinson’s experiencing OFF periods. The 339 patients in the trial had mild to moderate Parkinson’s and were on an oral levodopa plus a dopa-decarboxylase inhibitor (e.g., carbidopa). Most were on additional scheduled Parkinson’s medication and were experiencingat least two hours per day of OFF time. Patients with asthma, COPD, or other chronic lung disease within the previous five years were excluded. Patients were randomized into three treatment groups: 113 in the INBRIJA 60 mg group, 114 in the INBRIJA 84 mg group and 112 with placebo. The primary endpoint was the change in the Unified Parkinson’s Disease Rating Scale (UPDRS) motor scores from pre-dose to 30 minutes post-dose, evaluated at week 12 during an in-clinic OFF period. INBRIJA 84 mg showedstatistically significant improvement in motor function compared to placebo as measured by mean change in the UPDRS motor score at 30 minutes post-dose (-9.83 vs. -5.91; p=0.0088). Key secondary endpoints for INBRIJA versus placebo also were evaluated at week 12 using a pre-specified hierarchy. The order of hierarchy was set based on probability of success, guided by a Phase 2 study. The primary endpoint (INBRIJA 84 mg vs. placebo) was tested first for statistical significance. Upon achieving significance, the secondary endpoints were tested for INBRIJA 84 mg vs. placebo as long as each preceding endpoint reached a significance level of p<0.05. The hierarchical sequence did not reach statistical significance at Step 3. Unadjusted (nominal) p-values are presented below for all key secondary endpoints. About INBRIJA (levodopa inhalation powder) INBRIJA is the first and only inhaled levodopa for intermittent treatment of OFF episodes in patients with Parkinson’s disease treated with carbidopa/levodopa. INBRIJA utilizes Acorda’s innovative ARCUS® platform for inhaled therapeutics. A Marketing Authorization Application (MAA) for INBRIJA was submitted to the European Medicines Agency (EMA) in March 2018 and was formally validated in May 2018. Important Safety Information: INBRIJA is not to be used if patients take or have taken a nonselective monoamine oxidase inhibitor such as phenelzine or tranylcypromine within the last 2 weeks. 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 from a sleep disorder or if they get drowsy/sleepy without warning or take a medicine that increases sleepiness such as sleep medicines, antidepressants, or antipsychotics feel dizzy, nausea, sweaty, or faint when standing from sitting/lying down history of abnormal movement (dyskinesia) mental health problem such as hallucinations or psychosis uncontrollable urges (for example, gambling, increased sexual urges, intense urges to spend money, or binge eating) glaucoma 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), or isoniazid iron salts or multivitamins that contain iron salts No more than 1 dose (2 capsules) should be taken for any OFF period. No more than 5 doses (10 capsules) of INBRIJA should be taken in a day. INBRIJA is for oral inhalation only. INBRIJA capsules are not to be swallowed or opened. 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. INBRIJA can cause serious side effects including the following. Patients should tell their healthcare provider if they experience them: falling asleep during normal daily activities (such as driving, doing physical tasks, using hazardous machinery, talking, or eating) which can be without warning. If patients become drowsy while using INBRIJA, they should not drive or do activities where they need to be alert. Chances of falling asleep during normal activities increases if patients take medicines that cause sleepiness. withdrawal-emergent hyperpyrexia and confusion (symptoms including fever, confusion, stiff muscles, and changes in breathing and heartbeat) in patients who suddenly lower or change their dose or stop using INBRIJA orcarbidopa/levodopa medicines. low blood pressure with or without dizziness, fainting, nausea, and sweating. Patients should get up slowly after sitting or lying down. hallucinations and other psychosis – INBRIJA may cause or worsen psychotic symptoms including hallucinations (seeing/hearing 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; believing things that are not real, acting aggressive, and feeling agitated/restless. unusual uncontrollable urges such as gambling, binge eating, shopping, and sexual urges has occurred in some people using medicines 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 call their healthcare provider or go to the nearest hospital emergency room right away. 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.