FDA approves INBRIJA for rest treatment during Parkinson's disease shutdown
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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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Parkinson's disease is an progressive neurodegenerative disease caused by the gradual loss of certain neurons responsible for dopamine, which can lead to a range of symptoms, including impaired movement, muscle stiffness and tremorrecently, AcordaPharmaceutical(http:// announcedthat the U.SFood andMedicines(http://Administration (
FDA(http://) approved INBRIJA for the treatment of Cabedoba/Left leprosy (OFF) intermittent treatment of Parkinson's disease (OFF) treatmentabout INBRIJA
INBRIJA is an inhaled levodopa that allows patients to operate on their own, and is used to treat symptoms of the shutdown period in patients currently in patients with Parkinson's disease currently using Carbidobar/Left-spin-dobaINBRIJA was developed using Acorda's ARCUS platform to provide the lungs with an accurate dose of l-doba dry powder preparationsOral medications need to be absorbed through the stomach before reaching the brain, so the process of starting the action can changeInhalation therapy can enter the body through the lungs, reaching directly into the brain and bypassing the digestive system the approval of the of the SPANSM-PD Trial (http:// INBRIJA is based on the clinical phase 3 efficacy-critical trial SPANSM-PD, a 12-week, randomized, placebo-controlled double-blind study that aims to assess the effectiveness of INBRIJA in the OFF period experienced in patients with mild to moderate Parkinson's disease The subjects included about 900 patients with Parkinson's who were suffering from the on-off-off phenomenon in patients who had received the Kabidoba/Left-spin doba programme INBRIJA cannot be used in patients who have taken or taken non-selective monoamine oxidase inhibitors (such as phenylethyl or antiphenyl acrylamine) in the past two weeks test results showed that the SPAN-PD trial met its primary endpoint, and that patients showed a statistical improvement in motor function during the 12th week follow-up, with the values of INBRIJA 84 mg (n s 114) compared to placebo (n s 112) and 30 minutes after administration were -9.83 and 5.91 minutes, respectively, as measured by the Unified Parkinson's Disease Assessment Scale (UPDRS) Part III In key trials, the most common adverse reactions in INBRIJA (at least 5%, greater than placebo) were cough (15 percent vs 2 percent), upper respiratory tract infections (6 percent vs 3 percent), nausea (5 percent vs 3 percent), and sputum discoloration (5 percent vs 0 percent) INBRIJA also conducted a three-phase long-term, active-controlled, randomized, open label study (N -398) to assess drug safety and tolerability over a one-year period the study showed that the average reduction of FEV1 (one-second strong exhalation volume) was the same (-0.1 L) in patients in the INBRIJA group and in the observation group Patients with chronic obstructive pulmonary disease (COPD), asthma, or other chronic respiratory diseases were excluded from this study in the past five years
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