Recently, the innovative drug Diazepam Nasal Spray (VALTOCO) has issued its first prescription in the Guangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), which marks that the first Diazepam Nasal Spray in China has officially entered clinical application. It satisfies the unmet clinical needs of epilepsy emergency rescue outside the medical setting and brings a new acute treatment scheme for the seizure clusters/acute repetitive seizures of children and adults aged 6 and above with epilepsy.
(Guangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences) issued the first prescription of Diazepam Nasal Spray (VALTOCO))
So far, three innovative drugs successfully approved for marketing this year have officially entered the national scale clinical application, marking another important milestone for the company to promote the commercialization of innovative products.
On June 7, 2023, Diazepam Nasal Spray received approval from the National Medical Products Administration of China (NMPA). It is used for the seizure clusters/acute repetitive seizures of children and adults aged 6 and above with epilepsy, which is distinct from a patient’s usual seizure pattern, characterized by intermittent, stereotypic episodes of frequent seizure activity. On December 13th, the product was successfully included in the Category B of the new National Reimbursement Drug List (NRDL), which has a positive meaning in mitigating patients’ burden and improving medication accessibility.
VALTOCO is the first intranasal diazepam spray approved for use in seizure clusters/acute repetitive seizures in China. 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. Under the prescription and guidance of doctors and medical staffs, VALTOCO can be administered intranasally at any time and place, with rapid onset and differentiated advantages in epilepsy emergency rescue and convenient administration. It can meet the current clinical needs of acute treatment for seizure clusters/acute repetitive seizures in epilepsy patients in China.
(Diazepam Nasal Spray (VALTOCO))
Mr. Jiang Qingfu, General Manager of Cardio-cerebrovascular/ Gastroenterology Business (CMS Shenzhen), said that, “We are very happy to see that the first prescription of VALTOCO (Diazepam Nasal Spray) has been officially issued, allowing more epilepsy patients in China to use this high quality emergency product with reasonable price. This is the significance of our commitment to innovation driven and social responsibility. The successful commercialization of VALTOCO meets the unmet clinical needs of epilepsy emergency rescue outside the medical setting in China. It not only provides an innovative treatment plan for clinical doctors, but also brings convenient and rapid drugs for seizure clusters/acute repetitive seizures of epilepsy patients. Through our efficient commercial team’s efforts, we will achieve coverage in more hospitals of VALTOCO and escort more Chinese epilepsy patients. ”
At the recently concluded 10th CAAE International Epilepsy Forum, CMS reached a strategic cooperation with the China Anti-Epilepsy Association to establish the “CAAE-CMS Patients Caring Fund” to jointly improve the understanding and awareness of epilepsy among epilepsy patients and the public, assist in patient education, and improve disease management. Meanwhile, it helps to strengthen international exchanges in the epilepsy clinical treatment, and promotes the standardization of epilepsy emergency rescue outside the medical setting and diagnosis.
As a platform company linking pharmaceutical innovation and commercialization with strong product lifecycle management capability, CMS is dedicated to meet unmet healthcare needs. CMS leverages its own commercialization capabilities and clinical resources with scale effect to extensively cooperate with global innovation force to jointly develop innovative pharmaceutical products with academic value and differentiated advantages, improving Chinese patients’ accessibility to global innovative drugs. In 2023, CMS’s innovative achievements gradually landed, and 3 innovative products were successfully approved for marketing in China. 2 innovative products are under NDA review in China, and over 10 innovative products are steadily advancing China’s registered clinical trials with RCTs mainly. Simultaneously, a total of five drugs including Diazepam Nasal Spray (VALTOCO) have been included or continued to be included in the National Reimbursement Drug List (NRDL) since this year.
The exploration of innovation is a hindered and long way to go, but it has a very promising future. CMS will never forget its original intention, focus on the unmet medical needs in China, continue to explore new and good drugs with international quality, efficiently promote product clinical development and commercialization, provide more high-quality products for clinical needs, and contribute to safeguarding patients’ health and life.
About 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.