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Parkinson's New Drug! Inbrija, the first inhaled levodopa product, launched in the US to treat OFF symptoms
Author : admin Time : 2019-12-5Click :
March 4, 2019 / BIOON /-Biocor Therapeutics has announced the launch of Inbrija (levodopa inhalation powder) in the US market. The drug was approved by the US FDA on December 21, 2018 for use in Intermittent treatment for patients with Parkinson's disease who are taking carbidopa / levodopa for the OFF period.
It is worth mentioning that Inbrija is the first and only FDA-approved inhaled levodopa, which is convenient for patients to handle by themselves and is suitable for on-demand treatment during the OFF period. At present, levodopa is the "gold standard" for Parkinson's treatment.
Inbrija was developed using Acorda's proprietary ARCUS platform to provide patients with accurate doses of levodopa dry powder formulations in the lungs. In the case of oral administration, the drug will be absorbed through the stomach and stomach before reaching the brain, so the onset process will change. Inhalation therapy can enter the body through the lungs and reach the brain, bypassing the digestive system.
"The OFF period is very disruptive for those with Parkinson's disease," said Ron Cohen, president and CEO of Acorda. "We are pleased that Inbrija can now meet this important unmet medical need."
Inbrija's approval is based on data from the pivotal phase III clinical study, SPANSM-PD (NCT02240030). The study was a 12-week, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of Inbrija compared to placebo for patients with Parkinson's disease who are experiencing the OFF phase. The study included 339 patients with mild to moderate Parkinson's disease who were being treated with an oral levodopa and a dopa decarboxylase inhibitor (such as carbidopa). Most patients were also Receives additional Parkinson's disease medication, but is experiencing an OFF period of at least 2 hours per day. Patients with asthma, chronic obstructive pulmonary disease, or other chronic lung diseases within the past 5 years were excluded. In the study, these 339 patients were randomly divided into three treatment groups: the Inbrija 60mg group (113 patients), the Inbrija 84mg group (114 patients), and the placebo group (112 patients). The primary endpoint was the change in the Unified Parkinson's Disease Rating Scale (UPDRS) exercise score from pre-dose to 30 minutes after dosing, as assessed during an outpatient OFF event at week 12 of treatment.
The results showed that the study reached the primary endpoint: the mean change in UPDRS performance scores assessed 30 minutes after administration in the Inbrija 84mg treatment group was statistically significantly improved compared to the placebo group (-9.83 points vs -5.91 points, p = 0.0088). In addition, the study reached several key secondary endpoints.
It is worth mentioning that Inbrija is the first and only FDA-approved inhaled levodopa, which is convenient for patients to handle by themselves and is suitable for on-demand treatment during the OFF period. At present, levodopa is the "gold standard" for Parkinson's treatment.
Inbrija was developed using Acorda's proprietary ARCUS platform to provide patients with accurate doses of levodopa dry powder formulations in the lungs. In the case of oral administration, the drug will be absorbed through the stomach and stomach before reaching the brain, so the onset process will change. Inhalation therapy can enter the body through the lungs and reach the brain, bypassing the digestive system.
"The OFF period is very disruptive for those with Parkinson's disease," said Ron Cohen, president and CEO of Acorda. "We are pleased that Inbrija can now meet this important unmet medical need."
Inbrija's approval is based on data from the pivotal phase III clinical study, SPANSM-PD (NCT02240030). The study was a 12-week, randomized, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of Inbrija compared to placebo for patients with Parkinson's disease who are experiencing the OFF phase. The study included 339 patients with mild to moderate Parkinson's disease who were being treated with an oral levodopa and a dopa decarboxylase inhibitor (such as carbidopa). Most patients were also Receives additional Parkinson's disease medication, but is experiencing an OFF period of at least 2 hours per day. Patients with asthma, chronic obstructive pulmonary disease, or other chronic lung diseases within the past 5 years were excluded. In the study, these 339 patients were randomly divided into three treatment groups: the Inbrija 60mg group (113 patients), the Inbrija 84mg group (114 patients), and the placebo group (112 patients). The primary endpoint was the change in the Unified Parkinson's Disease Rating Scale (UPDRS) exercise score from pre-dose to 30 minutes after dosing, as assessed during an outpatient OFF event at week 12 of treatment.
The results showed that the study reached the primary endpoint: the mean change in UPDRS performance scores assessed 30 minutes after administration in the Inbrija 84mg treatment group was statistically significantly improved compared to the placebo group (-9.83 points vs -5.91 points, p = 0.0088). In addition, the study reached several key secondary endpoints.
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