China-based China Medical System Holdings Ltd (CMS; HKG: 0867) has announced receiving New Drug Application (NDA) approval from the National Medical Products Administration (NMPA) for its diazepam nasal spray. This dosage form is the first of its kind to gain approval in China and is set for use as a treatment for cluster seizure/acute recurrent seizures in children and adults aged 6 years and over.
Diazepam Nasal Spray: A First-Line Treatment for Cluster Seizures
Diazepam, a benzodiazepine, is considered the first-choice drug for the treatment of cluster seizures, an indication with limited strong treatment options in China at present. The proprietary preparation of diazepam administered through the nasal mucosa boasts high bioavailability, outstanding absorption, tolerance, and reliability. The product formula combines a unique combination of vitamin E solvent and Intravail absorption enhancement technology, enabling non-invasive delivery of various proteins, peptides, and small molecule drugs across the mucosa.
Asset Transfer and Global Reach
Diazepam was originated by Neurelis and was later acquired by A&B from a third party. CMS struck an asset transfer deal with A&B in August 2018, obtaining all rights to the drug in China mainland, Hong Kong, Macau, and Taiwan. The drug was approved in the US under the trade name of Valtoco in January 2020 and was awarded a 7-year orphan drug franchise.-Fineline Info & Tech
