Kangzhe Pharmaceutical's Diazepam Nasal Spray Application Accepted

Text | Sunshine

On July 6, CMS released an announcement announcing that the application for registration and marketing authorization of diazepam nasal spray has been accepted by the State Food and Drug Administration

It is estimated that there are about 6 million patients with active epilepsy in China, and there are about 400,000 new epilepsy patients every year

The product was developed by Neurelis, and CMS reached a cooperation with Neurelis in 2018 and introduced the product

Compared with intravenous diazepam, PK studies in healthy subjects showed that it has an absolute bioavailability of 96% and a bioavailability equivalent to that of diazepam rectal gel, while the variability is significantly reduced; epilepsy The PK study in patients showed similar exposure in seizure or non-seizure state and strong correlation with the pharmacokinetic results of healthy subjects; 12-month open label long-term safety of repeated medication in epilepsy patients Phase III clinical studies have shown that it has extraordinary tolerability and safety when repeated at home during epileptic seizures

PharmaGo shows that diazepam nasal spray is also the only and first product developed in the form of a spray in the development of domestic enterprises

Original title: The first application for the marketing of diazepam nasal spray was accepted