FDA Approves Parkinson’s Drug

Acorda Therapeutics gets okay for its levodopa drug delivered via an inhaler.

The approval by the US Food and Drug Administration (FDA) of Inbrija (levodopa inhalation powder) is good news for its manufacturer, Acorda Therapeutics, and for Parkinson’s patients. Just three months ago, the company lost a patent suit with a court ruling that invalidated its patents on its only marketed drug. The approval for the drug–device combination came several weeks earlier than expected and was welcome news for the firm. 

For patients with Parkinson’s disease who are already on background treatment with carbidopa/levodopa, Inbrija will be available in the first quarter of 2019 for the on-demand treatment of “off periods,” times when symptoms reappear despite receipt of baseline treatment. Acorda estimates that approximately 350,000 Americans suffer from these off periods. The current treatment involves the injection of apomorphine.

Another company – Sunovion – has developed an under-the-tongue version of apomorphine that it hopes will receive FDA approval in late January.

 

David Alvaro, Ph.D.

David is Scientific Editorial Director for That’s Nice and the Pharma’s Almanac content enterprise, responsible for directing and generating industry, scientific and research-based content, including client-owned strategic content. Before joining That’s Nice, David served as a scientific editor for the multidisciplinary scientific journal Annals of the New York Academy of Sciences. He received a B.A. in Biology from New York University and a Ph.D. in Genetics and Development from Columbia University.