Levodopa Inhalation Powder for Treatment of OFF Periods of Parkinson’s Approved

Wednesday, December 26, 2018

The Food and Drug Administration (FDA) has approved levodopa inhalation powder (Inbrija; Acorda Therapeutics, Ardsley, NY) for the intermittent treatment of OFF episodes in patients with Parkinson’s disease (PD) treated with levodopa-carbidopa. Levodopa inhalation powder capsules of 42 mg must not be swallowed or opened; using the Arcus inhaler, they are to be taken as a dose of 84 mg in 2 consecutive inhalations up to 5 times daily, as needed for treatment of the motor symptoms of OFF periods. Patients should not use levodopa inhalation powder within 2 weeks of having used monoamine oxidase inhibitors (MAOIs) and should continue their regimen of oral carbidopa-levodopa. 

This new formulation will be distributed through specialty pharmacies and is expected to be available in the first quarter of 2019. 

In clinical trials, patients with mild to moderate PD who were treated with levodopa inhalation powder (n = 114) had a statistically significant improvement in motor function as measured by a 9.83-point reduction in their Unified Parkinson’s Disease Rating Scale (UPDRS) score 30 minutes after taking a dose of the medicine compared with those given placebo (-5.9 points; = .009, n = 112). Improvement in motor symptoms was seen as quickly as 10 minutes after inhalation. In open-label extension trials, the safety and tolerability of levodopa inhalation powder was shown as no significant change in forced expiratory volume in 1 second (FEV1). The most common adverse reactions were cough, upper respiratory tract infection, nausea, and sputum discoloration.

“In the clinical study program, Inbrija established its safety profile and demonstrated clinically meaningful improvements in motor function, as measured by the UPDRS Part III,” said Robert A. Hauser, MD, MBA, Professor of Neurology and Director of the Parkinson's Disease and Movement Disorders Center at the University of South Florida. “Inbrija helps address a significant unmet need for people with Parkinson’s, and we look forward to adding this new treatment option to our armamentarium.”

“Despite being on treatment, patients may experience OFF periods as Parkinson’s progresses, which can be disruptive,” said Todd Sherer, PhD, CEO, The Michael J. Fox Foundation. “The Foundation provided funding for the early clinical development of Inbrija because patients told us that OFF periods were one of their most serious issues. We knew we had to help address this unmet need, and this approval is a significant step forward for the community as it provides a new option to manage these gaps in symptom control.”

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