China Medical System announces that the bridging trial for registration in China – the comparative PK study of its blockbuster innovative drug Diazepam Nasal Spray has been completed. The study result has shown the absorption of a single intranasal dose of Diazepam Nasal Spray is fast and complete and the pharmacokinetic parameters of diazepam and its active metabolite desmethyl diazepam were similar to those observed in relevant study in the U.S., achieved the expected targets. It has also been shown to be safe and well tolerated in healthy Chinese subjects.
The trial is a single-center, randomized, open-label, two-treatment, two-period, two-sequence, crossover comparative pharmacokinetic (“PK”) study. In accordance with the clinical trial notice issued by China NMPA, the Group is required to conduct this bridging trial to support its registration. The clinical result of this trial has further proved the good clinical performance of Diazepam Nasal Spray and has provided an important basis for the clinical use of the product in Chinese patients. The Group will submit registration application for Diazepam Nasal Spray in China in the near future.
About the Product
Diazepam Nasal Spray is a proprietary formulation which incorporates the unique combination of a vitamin E-based solvent and Intravail® absorption enhancement, which help it to obtain unparalleled absorption, tolerability, and reliability. Compared with intravenous diazepam, it has high absolute bioavailability and less variability. Diazepam Nasal Spray was approved for marketing in the U.S. 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 six years of age and older.
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.