In the spring, 2018 issue of MPDN, the drug INBRIJA was discussed (1). INBRIJA is a self-administered, orally inhaled form of levodopa (similar to an asthma inhaler) which if approved by the Food and Drug Administration (FDA), will be indicated for symptoms of OFF periods in people who take carbidopa/levodopa for Parkinson’s disease. In other words, it will serve as a rescue drug for OFF periods. As noted in that article, in February Acorda Therapeutics, Inc. announced the FDA had accepted the New Drug Application (NDA) for INBRIJA. Under the Prescription Drug User Fee Act (PDUFA), the FDA set a target date of October 5, 2018. However, the FDA announced on September 13 that PDUFA date for the drug been extended to January 5, 2019. This delay comes after Acorda provided more data in response to FDA requests for additional information on chemistry, manufacturing, and controls (CMC). Per the Acorda website press release, “FDA determined that these submissions constitute a major amendment and will take additional time to review” (2).
FDA approval of inhaled levodopa delayed
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