FDA Accepts NDA for Orally Inhaled Levodopa Therapy Inbrija

The FDA has set a PDUFA target date of October 5, 2018
The FDA has set a PDUFA target date of October 5, 2018

The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Inbrija (levodopa inhalation powder; Acorda), an investigational treatment for symptoms of OFF periods in patients with Parkinson's disease.

Inbrija (previously known as CVT-301) is a self-administered, orally inhaled levodopa; it is designed to deliver a precise dose of a dry powder formulation of L-dopa to the lung. The NDA is supported by results from the Phase 3 safety and efficacy study SPAN-PD and from 2 separate long-term safety studies. The 12-week SPAN-PD trial found that treatment with Inbrija 84mg resulted in a statistically significant improvement in motor function in patients with Parkinson's disease experiencing OFF periods. 

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"Inhaled delivery of levodopa could help the many people living with Parkinson's facing the complication of OFF periods as their disease progresses," said Todd Sherer, PhD, CEO of The Michael J. Fox Foundation, who granted funds to the Inbrija Phase 1 and 2 trials. 

The FDA has set a Prescription Drug User Fee Act target date of October 5, 2018. 

For more information visit Acorda.com