Klaria initiates large-scale production of KL-00119 oral film (sumatriptan) for its clinical registration trial
Today, Klaria announces that large-scale production of the company’s lead migraine product KL-00119 oral film (sumatriptan) has been initiated at its manufacturing partner Adhex Pharma’s site in Dijon, France. Initially, KL-00119 is produced for the pivotal clinical trial scheduled for 2020 prior to registration and marketing of the product.The clinical trial is currently designed to last approximately 8-10 weeks. It will be followed by market registration submissions based on the full data file to regulatory authorities covering all important markets, including the EU and the US.