Drug Overview
Inbrija (Acorda Therapeutics) is an inhaled formulation of levodopa, in development as an adjunct to existing oral levodopa formulations in patients experiencing motor fluctuations. Levodopa remains the gold-standard drug across all stages of Parkinson’s disease, although disease progression is associated with the onset of peaks and troughs in levodopa levels. These lead to “off” periods in which there is inadequate motor control, as well as peak-dose dyskinesia, where patients display drug-induced involuntary movements. Inbrija is designed to supplement existing levodopa treatment through as-needed self-administration, returning patients to an “on” state without inducing dyskinesia. Inbrija uses Civitas Therapeutics’ proprietary Arcus pulmonary delivery system. The use of an inhalable administration route means levodopa bypasses the digestive system, thus avoiding delays in absorption and quickly reaching the brain.
Acorda became responsible for Inbrija’s development after acquiring Civitas Therapeutics, the drug’s originator, in September 2014. Since then, Acorda has progressed Inbrija through Phase III development, and filed for regulatory approval in the US in June 2017. Although the initial New Drug Application was met with a Refusal to File letter, Acorda was able to promptly submit, with a potential October 2018 approval date. In Europe, Acorda anticipates filing Inbrija in 2018.
Inbrija (Acorda Therapeutics) is an inhaled formulation of levodopa, in development as an adjunct to existing oral levodopa formulations in patients experiencing motor fluctuations. Levodopa remains the gold-standard drug across all stages of Parkinson’s disease, although disease progression is associated with the onset of peaks and troughs in levodopa levels. These lead to “off” periods in which there is inadequate motor control, as well as peak-dose dyskinesia, where patients display drug-induced involuntary movements. Inbrija is designed to supplement existing levodopa treatment through as-needed self-administration, returning patients to an “on” state without inducing dyskinesia. Inbrija uses Civitas Therapeutics’ proprietary Arcus pulmonary delivery system. The use of an inhalable administration route means levodopa bypasses the digestive system, thus avoiding delays in absorption and quickly reaching the brain.
Acorda became responsible for Inbrija’s development after acquiring Civitas Therapeutics, the drug’s originator, in September 2014. Since then, Acorda has progressed Inbrija through Phase III development, and filed for regulatory approval in the US in June 2017. Although the initial New Drug Application was met with a Refusal to File letter, Acorda was able to promptly submit, with a potential October 2018 approval date. In Europe, Acorda anticipates filing Inbrija in 2018.
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