Potential New Rescue Therapy for Cluster Seizures, Midazolam Nasal Spray, Acquired by UCB
UCB has announced an agreement to acquire the rights to midazolam nasal spray (USL261), intended as a rescue therapy for acute repetitive series (ARS), or cluster seizures. The company expects to file a new drug application for this currently investigational therapy with the Food and Drug Administration in 2018.
The novel formulation of USL261, a nasal spray that does not require active inhalation, is expected to provide a new therapeutic option for the approximately 150,000 individuals with refractory epilepsy who experience ARS. Currently, effective treatment is achieved in less than 40% of patients with ARS, thought to be the case in part because emergent rectal administration required by available therapies is problematic for many patients.
In a phase 3 clinical trial that evaluated efficacy and safety, primary endpoints were met including termination of seizure(s) within 10 minutes after drug administration and no recurrence for an additional 6 hours.
Mike Davis, Head, US Neurology Patient Value Unit of UCB noted that, “This acquisition is a natural fit for us because of our mission to be a partner to patients, remaining focused on their needs in order to better unlock the match between the individual patient and the therapeutic solution along the treatment journey they experience. If approved, USL261 will bridge a gap that currently exists, giving patients a novel formulation and delivery option to confidently address ARS.”