Neurelis¡¯ Product VALTOCO Nasal Spray (NRL-1) is Approved by the U.S. FDA
2020-01-14 15:34

CMS dated 20 August 2018 and 26 September 2018 related to the asset purchase of the pharmaceutical preparation, formulation, dosage form, or delivery vehicle, containing or comprising NRL-1 etc. and/or line extensions and the submission of the New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for VALTOCO (diazepam nasal spray) by Neurelis, respectively. NRL-1 (intranasal diazepam) is a proprietary formulation of diazepam, delivered via a nasal formulation in a spray, 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 Previous Announcements have the same meanings when used in this announcement.

On 13 January 2020, Neurelis announced that the U.S. FDA had approved its product VALTOCO (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient¡¯s usual seizure pattern in people with epilepsy 6 years of age and older.

CMS has been actively carrying out the regulatory application and other related work of VALTOCO in China since Neurelis submitted the NDA to the U.S. FDA, and has recently acquired the clinical trial notice of diazepam nasal spray from the National Medical Products Administration of the People¡¯s Republic of China. CMS is required to conduct a comparative pharmacokinetic study in Chinese subjects, and to submit a post-marketing study plan to further verify the efficacy and safety at the same time of submitting the NDA.