UCB announced that the FDA has accepted its new drug application for USL261 midazolam nasal spray for the rescue treatment of seizures in epilepsy patients. The company announced in April 2018 that it had acquired rights to the nasal spray from former Upsher Smith subsidiary Proximagen.
USL261 has previously received both orphan drug designation and fast track designation from the FDA. Proximagen announced positive results from the Phase 3 ARTEMIS 1 study in April 2017.
UCB Executive VP and Head of Neurology Jeff Wren said, “Managing seizure clusters remains a challenge for thousands of patients and caregivers, in the US and beyond, who live their lives each day with this debilitating condition. There is an unmet need for effective and convenient acute treatment of seizure clusters that can rapidly end ongoing seizures and potentially prevent or delay their reoccurrence. With midazolam nasal spray, UCB hopes to expand and diversify the treatment choices we are able to provide to the epilepsy community, complementing our already strong epilepsy portfolio and providing additional solutions to help patients.”
Read the UCB press release.
