Date: 2016-01-19
Type of information: Initiation of the trial
phase:
Announcement: initiation of the trial
Company: Neurelis (USA - CA)
Product: NRL-1 (intranasal diazepam)
Action
mechanism: benzodiazepine . NRL-1 (intranasal diazepam) is a proprietary formulation of diazepam, delivered via an already marketed nasal sprayer, being developed for the management of pediatric and adult patients who require intermittent use of diazepam to control bouts of acute repetitive seizure activity. In clinical trials, NRL-1 has demonstrated high bioavailability, low variability from dose to dose, and was well-tolerated.
Disease: epilepsy patients who experience acute repetitive seizures
Therapeutic area: Rare diseases - CNS diseases
Country:
Trial details:
Latest
news: * On January 19, 2016, following the receipt of Orphan Drug Designation for its lead product, NRL-1 (intranasal diazepam), Neurelis announced the receipt of guidance from the FDA for the final clinical trial requirements necessary for approval of NRL-1. NRL-1 is being developed for pediatric, adolescent, and adult epilepsy patients who experience Acute Repetitive Seizures. Neurelis has initiated the pivotal clinical trials program to support a New Drug Application (NDA) in the US.
