The Japan Patent Office has allowed JP Application No. 2014-515967 which covers Neurelis’ NRL-1 intranasal diazepam formulation, the company said. In January 2017, Neurelis received Fast Track designation from the US FDA for NRL-1, which had previously received Orphan Drug designation in 2015.
The company announced the initiation of pivotal trials for NRL-1 for the treatment of acute repetitive seizures in epilepsy patients at the beginning of 2016 and now says that it is putting together its NDA submission for the US FDA, with plans for further filings in Japan and other countries.
Neurelis President and CEO Craig C. Chambliss said, “We are very excited about the decision of the Japan Patent Office to award this important patent for NRL-1. As part of the global patent strategy for our proprietary intranasal formulations, we are pleased to add the Japanese patent to the growing list of issuances in Australia, Canada, Denmark, France, Germany, Ireland, Italy, Netherlands, Spain, Great Britain and the United States.”
Read the Neurelis press release.