On October 21, in Yiyang Central Hospital of Hunan Province, the first dosing of all subjects has been completed in the comparative PK study, the bridging trial for registration in China, of China Medical System’s blockbuster innovative drug Diazepam Nasal Spray. It is an important milestone in the product’s registration process in China.
The trial is a single-center, randomized, open-label, two-treatment, two-period, two-sequence, crossover comparative pharmacokinetic (“PK”) study in which 24 healthy subjects were enrolled. The primary objective of this study is to investigate the pharmacokinetics and bioavailability of diazepam nasal spray and diazepam injection in healthy subjects under fasted conditions. In accordance with the clinical trial notice issued by China NMPA, the Group is required to conduct this bridging trial to support its registration, and will submit a post-marketing clinical study plan to further verify the product’s efficacy and safety while submitting the NDA.
Diazepam Nasal Spray
An Innovative Drug for Acute Repetitive
Seizures That is Convenient to Use outside the Medical Setting and with a Very
Rapid Onset of Action
Diazepam Nasal Spray was developed by Neurelis, a U.S. company that CMS made equity investment. The Group owns all the assets of the product in Mainland China, Hong Kong, Macao and Taiwan. In January 2020, Diazepam Nasal Spray was approved for marketing by the U.S. FDA under the VALTOCO® brand name for the treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) in patients with epilepsy 6 years of age and older. The product’s formulation incorporates the unique combination of a vitamin E-based solvent and Intravail® absorption
enhancement with the goal of obtaining unparalleled absorption, tolerability, and reliability in a nasal formulation. Compared with intravenous diazepam, it demonstrates 96% absolute bioavailability and less variability.
There are about 6 million active epilepsy patients in China, and about 0.4 million new cases reported each year. In patients with epilepsy who have received regular treatment (about 2 million), 20%-30% are still out of effective control and have frequent recurrent seizures, and the mean number of seizures per year can be up to nearly 70 times. Once approved in China, Diazepam Nasal Spray will become a long-term prepared, safe and effective medicine for patients with acute repetitive seizures, and its market potential is promising.