FDA Clears Inhaled Parkinson’s Drug

(NIH.gov)

27 Dec. 2018. A drug administered as an inhaled powder to supplement a common treatment for Parkinson’s disease received approval for marketing from the Food and Drug Administration. Acorda Therapeutics Inc. in Ardsley, New York says FDA approved Inbrija, the drug’s brand name, on 21 December.

Parkinson’s disease occurs when the brain produces less of the substance dopamine, a neurotransmitter that sends signals from one neuron or nerve cell to another. As the level of dopamine lowers, people with Parkinson’s disease become less able to control their bodily movements and emotions. Symptoms include tremors, i.e. shaking, slowness and rigidity in movements, loss of facial expression, decreased ability to control blinking and swallowing, and in some cases, depression and anxiety. According to Parkinson’s Disease Foundation, some 60,000 new cases of Parkinson’s disease are diagnosed in the U.S. each year, with more than 10 million people worldwide living with the disease.

A drug usually prescribed for Parkinson’s disease is levodopa that the body converts to dopamine and helps reduce the disease’s symptoms. Levodopa is often combined with carbidopa to prevent levodopa from releasing prematurely, which allows for lower doses, reducing side effects such as nausea and vomiting. The beneficial effects of levodopa for Parkinson’s patients, however, are not always automatic, resulting in “off” periods when dopamine levels drop and symptoms return. These off-periods occur more often among people taking levodopa for longer periods of time.

Inbrija, says Acorda, is a drug designed — and FDA approved — to supplement levodopa during those off periods when the drug’s main effects wane. Acorda’s technology, called Arcus, formulates levodopa in a fine powder that the patient inhales into the lungs, where the drug enters the blood steam, bypassing the digestive system. Arorda says its technology alters the size and shape of the drug’s molecules, allowing for greater concentrations of the drug to enter the blood stream and then the brain.

The company says it tested Inbrija in a series of late-stage clinical trials with more than 900 Parkinson’s disease patients to supplement regular levodopa-carbidopa treatments during their off periods. Acorda acquired the Arcus technology from biotechnology company Civitas Therapeutics in 2014. Civitas conducted earlier clinical trials of the inhaled drug funded by the Michael J. Fox Foundation. Science & Enterprise reported on the foundation’s support for the earliest of those trials in 2011.

Acorda expects to make Inbrija commercially available in the first quarter of 2019. FDA approved the drug on 21 December, before the agency closed with much of the federal government due to a lapse in appropriated funds.

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