China Medical System Holdings Limited has announced that the first Diazepam Nasal Spray has been approved for marketing in China, making it the first drug approved in China for the treatment of seizure clusters. The product is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient's usual seizure pattern in patients with epilepsy 6 years of age and older. It is administered through the nasal mucosa and has high bioavailability, outstanding absorbability, tolerance, and reliability. The active pharmaceutical ingredient is Diazepam, belonging to the class of benzodiazepines, which are the first-choice drugs for the treatment of seizure clusters. There are about 6.4 million active epilepsy patients in China but due to limited medical resources and lack of proper awareness towards epilepsy, it is estimated that about 3 million patients have not received appropriate treatment.
The Diazepam Nasal Spray can be administered intranasally at any appropriate time by patients or their caregivers under prescription from a doctor and guidance from medical staff. The formulation incorporates a unique combination of Vitamin E-based solvents and Intravail absorption enhancer technology enabling non-invasive delivery. In US related clinical trials, 87% of seizure cluster episodes used a single dose over a 24-hour period