CHMP Backs Inhaled Levodopa (Inbrija) for Parkinson's 'Off' Episodes

Megan Brooks


July 26, 2019

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of an inhaled form of levodopa (Inbrija, Acorda Therapeutics) for intermittent treatment of episodic motor fluctuations ("off" episodes) in Parkinson's disease (PD) in adults treated with a levodopa/dopa-decarboxylase inhibitor.

The US Food and Drug Administration (FDA) approved Inbrija for the same indication last year, as reported by Medscape Medical News.

The efficacy of levodopa inhalation powder was demonstrated in the randomized, double-blind, placebo-controlled, phase 3 SPAN-PD trial of patients with mild to moderate PD experiencing "off" periods while taking carbidopa-levodopa.

The trial met its primary endpoint, with patients using levodopa inhalation showing significant improvement in motor function at the week 12 visit, as indicated by a reduction in Unified Parkinson's Disease Rating Scale Part III (UPDRS III) score, compared with those taking placebo.

The change at week 12 in UPDRS III score was –9.83 for patients receiving the 84-mg dose vs –5.91 for the group taking placebo (P = .009). Onset of action was seen as early as 10 minutes.

The most common adverse reactions with inhaled levodopa were cough, upper respiratory tract infection, nausea, and discolored sputum.

Once approved in Europe, Inbrija will be available as hard capsules containing inhalation powder (33 mg) to be used with an oral inhaler. The most common side effects are cough, falls, upper respiratory tract infections, new or increased dyskinesia, and discolored sputum.

Detailed recommendations for the use of inhaled levodopa will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after marketing authorization has been granted by the European Commission.

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