Recently, Neurelis announced that it has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for VALTOCO? (diazepam nasal spray) as a treatment for epilepsy patients six years and older who experience bouts of increased seizure activity, also known as acute repetitive or cluster seizures. Earlier this year, FDA provided conditional acceptance for use of the name “VALTOCO” for the product previously referred to in clinical development as “NRL-1”.
As early as the August 20, 2018, China Medical System Holdings Limited has announced the asset purchase of the pharmaceutical preparation, formulation, dosage form, or delivery vehicle, containing or comprising NRL-1 etc. and/or line extensions. NRL-1 (intranasal diazepam) is a proprietary formulation of diazepam, delivered via a nasal formulation in a spray, being developed for the management of pediatric and adult patients who require intermittent use of diazepam to control bouts of increased seizure activity, also known as acute repetitive or cluster seizures. Unless the context otherwise requires, terms defined in the Announcement have the same meanings when used in this announcement.
CMS will prepare for the regulatory application and other related work of VALTOCO in China after Neurelis submits the NDA with FDA for it.