Inbrija, inhaled levodopa for patients’ off episodes, arrives in Spain

Quick-acting treatment of symptoms returning between standard levodopa doses

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by Andrea Lobo |

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Inbrija (levodopa inhalation powder), an approved therapy for off episodes in Parkinson’s patients on certain standard levodopa-based treatments, is now available in Spain.

Developed by Acorda Therapeutics, the therapy was approved in the U.S. in 2018 and for the European Union in 2019.

In Spain and Germany — where it was launched in June — Inbrija is being sold by Esteve Pharmaceuticals under a commercialization agreement with Acorda, which will receive a percentage of revenues from Inbrija sales in both countries.

“Today’s announcement is great news for people in Spain who are living with Parkinson’s and suffer from off periods,” Ron Cohen, MD,  Acorda’s president and CEO, said in a company press release.

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One dose of Inbrija can be given up to five times each day for off episodes

“Esteve is a leader in commercializing central nervous system therapeutics in Spain. They will be educating neurologists about providing patients with the ability to treat their off periods on-demand with Inbrija,” Cohen added.

Parkinson’s is estimated to affect at least 160,000 people in Spain, according to the Spanish Parkinson’s Federation and the country’s Ministry of Health, Social Services, and Equality. The Spanish Society of Neurology indicates that about 10,000 new Parkinson’s cases are diagnosed each year.

The disease is caused by the progressive loss of nerve cells that produce dopamine, a major brain chemical messenger. Levodopa, a molecule that can be converted into dopamine, is a standard treatment for Parkinson’s motor symptoms, as it can increase dopamine levels in the brain.

Levodopa usually is given in combination with molecules like carbidopa, which work to prevent it from converting to dopamine before reaching the brain. Otherwise, higher doses of levodopa would be needed for the same treatment effect.

Still, long-term use of levodopa-based treatments is known to lower their effectiveness, and patients experience more frequent off periods — times when symptoms are not effectively controlled between treatment doses.

Inbrija is a dry inhalation powder formulation of levodopa that delivers a dose of levodopa directly to the lungs, where it more easily enters the bloodstream and, consequently, the brain. As such, it helps to rapidly stabilize a patient’s symptoms during off episodes.

Inbrija is administered using Acorda’s ARCUS pulmonary system, a hand-held inhaler that is activated by a patient’s breath. The system transforms medicines into light and dry powders for inhalation.

According to its European Medicines Agency label, one, two-capsule dose of Inbrija can be given to treat an off episode, and up to a maximum of five doses can be taken each day.

Regulatory approvals were based on findings in two Phase 3 trials (NCT02240030 and NCT02352363) involving more than 750 people with Parkinson’s who were experiencing off periods while on standard levodopa-based treatment.

The therapy, compared with a placebo, significantly reduced motor symptoms 30 minutes after dosing during off episodes, and did not significantly affect lung function.

The most common side effects reported with Inbrija’s use include cough, nausea, and upper respiratory infections.

Acorda also reported a commercialization agreement covering Inbrija with Biopas Laboratories for Latin American markets, including Mexico and Brazil. The company is in ongoing discussions regarding such rights in other European countries and elsewhere.