Proximagen announced promising data from the pivotal Phase 3 trial of USL261 (intranasal midazolam) for the rescue treatment of seizure clusters.

The ARTEMIS1 (Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray) study was designed to evaluate the efficacy and safety of USL261 as a rescue therapy in patients who require control of intermittent bouts of increased seizure activity, such as seizure clusters or acute repetitive seizures. The primary efficacy endpoint was treatment success, defined as achieving: 1) termination of seizure(s) within 10 minutes after study drug administration, and 2) no recurrence of seizure(s) beginning 10 minutes after administration of study drug to six hours after.

Top-level analysis of the data showed that the trial met its primary efficacy endpoint. The study also found USL261 to be generally safe, with an adverse effect profile consistent with that of midazolam, intranasal drug delivery, and those previously observed across the clinical development program to date. Detailed findings will be presented at the upcoming Antiepileptic Drug and Device Trials (AEDD) meeting on May 17–19 in Florida. Based on the positive results of this study, Proximagen plans to prepare for a New Drug Application (NDA) submission in the second half of this year.

USL261 is a novel, investigational midazolam formulation designed for intranasal delivery.

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