Proximagen Ltd. said today that its pivotal Phase III trial of intranasal midazolam met its primary efficacy endpoint as a treatment for patients with seizure clusters. The Cambridge-based company said it plans to begin talks with the FDA for a New Drug Application in the 2nd half of this year based on the trial’s findings.
The company’s USL261 formulation was developed for intranasal delivery in patients who require control of intermittent bouts of heightened seizure activity.
“The primary efficacy results observed in the pivotal phase III 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,” president Bill Pullman said in prepared remarks. “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.”
The Artemis1 study examined the efficacy and safety of USL261. Proximagen reported that the drug terminated seizures within 10 minutes after administration and prevented seizure recurrence for as long as 6 hours after administration.
Proximagen’s parent company, Upsher-Smith Laboratories, recently sold its generics biz to Sawai and Proximagen was bought by a newly created holding company, Acova.
“Given the challenges and unmet needs of those living with seizures, we are very encouraged by the results of the Phase III 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,” Acova CEO Mark Evenstad added. “I am very proud of the important work that Proximagen is doing to help patients and their families by discovering and developing innovative therapies.”