UCB said that the FDA has approved an NDA for Nayzilam midazolam nasal spray (formerly USL261) for the treatment of seizure clusters in epilepsy patients aged and older. UCB acquired the nasal spray from former Upsher Smith subsidiary Proximagen in April 2018 and announced in August 2018 that the FDA had accepted the NDA.
The midazolam nasal spray was granted orphan drug designation by the FDA in 2009 and was acquired by Upsher-Smith in 2010. Upsher-Smith announced in 2012 that a Phase 3 study of USL261 had begun recruiting. According to clinicaltrials.gov, the Phase 3 study began in 2011 and ended in 2017, enrolling a total of 201 patients. In April 2017, Proximagen,reported positive Phase 3 results for USL261 in then that it expected to submit a 505(b)(2) NDA by the end of that year.
UCB CEO Jean-Christophe Tellier commented, “As global leaders in epilepsy, the approval of Nayzilam complements our already strong epilepsy portfolio, improving our ability to provide value to people living with poorly controlled seizures, and builds on our passion and expertise in this field. We are pleased to expand and diversify the solutions we can offer to the epilepsy community, providing an innovative and differentiated solution to help support management of seizure clusters,”
Read the UCB press release.
