- CMS is pleased to announce the NDA of the first Diazepam Nasal Spray has been approved for marketing in China. The Product can meet current clinical needs for accessible and convenient treatment option of domestic epilepsy patients 6 years of age and older with seizure clusters/acute repetitive seizures. 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 the Product has high bioavailability, outstanding absorbability, tolerance and reliability
- In 2023, CMS’s innovation development is stepping into a new cycle of harvesting, and the Product is CMS’s third innovative drug approved for marketing in China this year
On June 12, China Medical System Holdings Limited (“CMS” or the “Group”) announced that on June 7 2023, the New Drug Application (NDA) of Diazepam Nasal Spray (the “Product”) 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 is a proprietary formulation of diazepam administered through the nasal mucosa, and has high bioavailability, outstanding absorbability, tolerance and reliability. Product formulation incorporates a combination of Vitamin E-based solvents and Intravail® absorption enhancer. Intravail® transmucosal absorption enhancement technology enables the non-invasive delivery of a broad range of proteins, peptides and small-molecule drugs.
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. In 2020, the Product was approved for marketing in the United States of America.
The active pharmaceutical ingredient of the Product is Diazepam, belonging to the class of benzodiazepines, which are the first-choice drugs for the treatment of seizure clusters. However, there has been a lack of drugs for the treatment of seizure clusters in the China. The Product is the first drug approved in China for the treatment of seizure clusters. It can be administered intranasally at the appropriate time by patients or their caregivers under prescription from a doctor and guidance from medical staff. The Product can meet current clinical needs for accessible and convenient treatment option of domestic epilepsy patients with seizure clusters. The Product can be administered anytime and anywhere, and has the differentiated advantage of seizure rescue, with the characteristic of convenience and optimization through intranasal administration.
CMS has always focused on unmet clinical needs, and joined hands with global innovation forces to build a pharmaceutical innovation ecosystem in an open and collaborative setting, to continuously develop differentiated innovative products for patients. Starting from 2023, CMS’s innovation development is stepping into a new cycle of harvesting. Diazepam Nasal Spray is CMS’s third innovative drug approved for marketing in China this year, following the approval of Methotrexate Injection and Tildrakizumab Injection. CMS will steadily prepare for the commercialization of innovative products to benefit more patients in China as soon as possible.
Seizure Clusters/Acute Repetitive Seizures
According to the clinical diagnosis and treatment guidelines epilepsy volume (revision in 2023), seizure clusters/acute repetitive seizures are defined as ≥3 seizures/24h for adults, ≥3 seizures/12h for children, ≤8h between each seizures, and the consciousness returning to normal level between the two seizures. Seizure clusters are common in certain epilepsy syndromes, menstrual seizures, and drug-refractory epilepsy. If not treated in time, some will develop into status epilepticus, endangering the lives of patients.
According to estimation, there are about 6.4 million active epilepsy patients in China, and about 0.3 million new cases reported each year. However, due to a lack of proper awareness towards epilepsy and limited medical resources, the current treatment gap for patients with active epilepsy in China is 49.8%, based on which it is estimated that about 3 million patients with active epilepsy in China have not received appropriate treatment. At present, there is still a lack of epidemiological research on seizure clusters in China. According to overseas studies, the rate of outpatient incidence of seizure clusters is about 15% and therefore it is estimated that nearly 500,000 patients with active epilepsy receiving regular treatment still have seizure clusters.
For further detailed information regarding Diazepam Nasal Spray, please see the following link for “Voluntary and Business Update Announcement: New Drug Application of Diazepam Nasal Spray Approved in China” issued by CMS on June 12, 2023.