Posted from: Thursday, February 07, 2019 - 05:07 PM - Present

Inbrija Approved to Treat

December 21, 2018 – The U.S. FDA has approved Inbrija™ (levodopa inhalation powder), manufactured by Acorda Therapeutics, to provide intermittent treatment of “off” episodes in people with Parkinson’s disease treated with carbidopa/levodopa. An “off” episode is characterized by a return of symptoms due to a decrease in dopamine levels between taking maintenance doses of oral carbidopa/levodopa.

An estimated 60,000 patients are diagnosed with Parkinson’s annually in the United States. The current standard of treatment is oral carbidopa/levodopa, which increases the amount of dopamine in the body and helps to improve motor function. However, the efficacy of this treatment can wear off over time, leading to “off” episodes. For some patients, the occurrence of “off” episodes is predictable, but others may experience these episodes seemingly at random.

In a clinical study, patients treated with Inbrija experienced a statistically significant improvement in motor function compared to those who received a placebo, as measured by the Unified Parkinson’s Disease Rating Scale (UPDRS). The onset of action occurred as early as 10 minutes after taking the medication. Recommended dosing is 84mg taken as needed up to five times daily. Patients should not exceed 84mg per dose, or 420mg per day.

Inbrija will be available in 42mg capsules designed for use with the Inbrija inhaler. Acorda Therapeutics plans to launch the product during the first quarter of 2019. Pricing plans have not yet been announced.

Last Updated Wednesday, February 20, 2019 - 03:59 AM.