FDA approves Inbrija (Left-handed Doba Inhalation Powder) for treatment of Parkinson's disease
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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recently, Acorda Therapeutics(http:// announcedthat the key Phase III efficacy study spanSM-PD (NCT02240030) for the treatment of Patients with Parkinson's disease (PD) in Inbrija (Left-handed doba inhalation powder) has been published in the Lancet Neurology Journalbased on SPANSM-PD research data, the u.SFDA(http://approved Inbrija in December 2018 for intermittent treatment for patients with Parkinson's disease (OFF) treated with TheCabedoba/Left-spindobaAcorda expects to bring Inbrija to the U.Smarket in the first quarter of 2019about Inbrija
Inbrija is an inhalable levodoba that allows the patient to operate on its own and is used to treat off-period (OFF) symptoms of patients currently taking Carbidobara/Left-handed dopaInbrija has been developed using Acorda's proprietary ARCUS platform to provide accurate doses of l-doba dry powder preparations to the patient's lungsIn oral cases,drug(http://are absorbed through the stomach before reaching the brain, so the process of effect changesInhalation therapy can enter the body through the lungs, reaching directly into the brain and bypassing the digestive systemrelated studies
SPANSM-PD is a 12-week, randomized, placebo-controlled, double-blind study designed to assess the efficacy and safety of Inbrija compared to placebo for patients with Parkinson's disease who are experiencing OFF stagethe study enrolled 339 patients with mild to moderate Parkinson's disease who were being treated with an oral l-palate and a doba deoxidal inhibitor, such as carbide, and most patients were receiving additional Parkinson's disease medication, but were experiencing a period of at least two hours a dayPatients with asthma, chronic obstructive pulmonary disease, or other chronic lung disease have been excluded in the past 5 yearsin thestudy, the 339 patients were randomly divided into three treatment groups: Inbrija 60mg (113), Inbrija 84mg (114), and placebo (112)The main endpoint was the change in the Uniform Parkinson's Disease Score Scale (UPDRS) movement score from before and after administration 30 minutes, assessed during an outpatient OFF event in week 12results showed that the study reached its main endpoint: the average change in UPDRS performance scores assessed 30 minutes after intake in the Inbrija 84mg treatment group showed a statistically significant improvement (-9.83 vs.5.91, p.0088)In addition, the study reached several key secondary endpoints
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