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news.Neurelis has received an Investigational New Drug application (IND) from the US Food and Drug Administration (FDA) to begin clinical trials advancing the development of NRL-1 (intranasal diazepam) for the treatment of acute breakthrough seizures.
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NRL-1 is a proprietary formulation of diazepam delivered via a commercially available nasal sprayer, and is being developed for the management of patients who require intermittent use of diazepam.
Based upon the earlier encouraging human pharmacokinetic results, the company has filed the IND.
Neurelis chairman David F Hale said they hope that NRL-1 has demonstrated a pharmacokinetic profile and bioavailability compared with previous attempts at the intranasal delivery of benzodiazepines.
"With the successful development of NRL-1 and approval from the FDA and other regulatory agencies, we look forward to making this product available to those patients who have epilepsy and suffer from acute repetitive seizures," Hale added.
San Diego-based specialty pharmaceutical company, Neurelis, aims to license, develop, and commercialize product candidates for epilepsy and the broader central nervous system market.