In June 2023, the New Drug Application (NDA) of Diazepam Nasal Spray received approval from the National Medical Products Administration of China (NMPA). The Product is the first diazepam nasal spray in China, and it is indicated for the 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 patients with epilepsy 6 years of age and older.The Product can be administered at anytime and anywhere, and has the differentiated advantage of seizure rescue, with the characteristic of convenience and optimization through intranasal administration. The Product’s formulation incorporates a unique combination of Vitamin E-based solvents and Intravail® absorption enhancer, and it has high bioavailability, outstanding absorbability, tolerance and reliability.
The product’s bridging trial in China, which is a comparative pharmacokinetics（PK）study, showed that the absorption of a single intranasal dose of Diazepam Nasal Spray was fast and complete, which demonstrated relatively high absolute bioavailability and achieved the expected targets; it was also shown to be safe and well-tolerated in healthy Chinese subjects. The results of the Product’s US related clinical trial showed that 87% of seizure cluster episodes used a single dose of the Product over a 24-hour period. A post hoc analysis of these data showed the Product had a rapid onset of action with the median time from administration of the Product to seizure cessation of 4 minutes. Further analyses showed using the Product as intermittent rescue therapy significantly improves the quality of life of epileptic patients and may reflect a beneficial effect in increasing time between seizure clusters.
According to estimation, there are about 6.4 million active epilepsy patients in China, and about 0.3 million new cases reported each year. The current treatment gap for patients with active epilepsy in China is 49.8%, and the rate of outpatient incidence of seizure clusters is about 15%;Therefore it is estimated that nearly 500,000 patients with active epilepsy receiving regular treatment still have seizure clusters. The Product is the first drug approved in China for the treatment of seizure clusters. It can meet current clinical needs for accessible and convenient treatment option of domestic epilepsy patients with seizure clusters.