Upsher Smith subsidiary Proximagen has announced that the Phase 3 ARTEMIS1 (Acute Rescue Therapy in Epilepsy with Midazolam Intranasal Spray) study of its USL261 intranasal midazolam for the treatment of seizure clusters, met its primary efficacy endpoint. Proximagen says that it plans to submit a 505(b)(2) NDA for the product by the end of the year.
The primary efficacy endpoint of the study was “treatment success,” which Proximagen defines “as achieving both of the following: 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 study drug administration.”
The FDA granted USL261 orphan drug designation in 2009, and Upsher Smith acquired the product from Ikano Therapeutics in 2010. Proximagen will become a wholly owned subsidiary of recently created holding company ACOVA when the sale of Upsher Smith’s generics business to Sawai is completed.
Proximagen President Bill Pullman commented, “The primary efficacy results observed in the pivotal phase 3 clinical trial were both statistically and clinically significant. These findings suggest that midazolam nasal spray could be an effective rescue treatment option for patients and caregivers who live with seizure clusters, subject to FDA review. This is an exciting development because to-date, rescue treatment options for seizure clusters have been very limited. We look forward to working with the FDA and submitting a new drug application for midazolam nasal spray later this year.”
ACOVA CEO Mark Evenstad said, “Given the challenges and unmet needs of those living with seizures, we are very encouraged by the results of the Phase 3 trial of midazolam nasal spray. While there is still work to be done to put this medication into the hands of patients, I’d like to take this opportunity to thank our investigators, along with the teams at Upsher-Smith and Proximagen who have brought us to this major milestone. I am very proud of the important work that Proximagen is doing to help patients and their families by discovering and developing innovative therapies.”
Read the Proximagen press release.
