Aculys Pharma says that it plans to move ahead with submission of a marketing application to Japanese authorities based on interim data showing that a Japanese Phase 3 clinical study of NRL-1 diazepam nasal spray in epilepsy patients aged 6 to 17 met its primary efficacy endpoint. Aculys acquired development and commercialization rights to Neurelis’s NRL-1 diazepam nasal spray (Valtoco) in a number of Asia Pacific countries in January 2022. Valtoco has been approved in the US for the treatment of seizures in patients aged 6 and older since 2020.
Aculys President and Representative Director Kazunari Tsunaba commented, “We believe that access to emergency treatment that is convenient and easy for non-medical personnel to use appropriately in the event of a seizure, in addition to being effective and safe, will help reduce the emotional burden on patients and their caregivers, as well as the risk of sequelae due to prolonged seizures.”
Tsunaba continued, “Intranasal anticonvulsants, which are easy for families and caregivers to administer to patients with epileptic seizures, have been approved in the US since 2020 and are widely used there. In our efforts to eliminate the problems of drug lag and drug loss, we will continue to work with medical professionals and regulatory authorities to promote our business in order to bring innovative treatments and hope to patients with recurrent seizures and their caregivers as soon as possible.”
Read the Aculys Pharma press release.
