Announcement on Application Acceptance of Lacosamide Oral Solution

Generic Name: Lacosamide Oral Solution

Dosage form: Oral solution

Registration Category: 5.2 Category

Our company and HETERO LABS LIMITED, India has reached a cooperation on Lacosamide Oral Solution in 2019. We are exclusively responsible for the registration and commercialization of this product in mainland China. The product submission was formally accepted by the Center for Drug Evaluation, NMPA on June 6, 2020, and has entered the review stage.

Lacosamide, a functional amino acid, is the only known antiepileptic drug in clinical practice that selectively inhibits slow sodium channels and is suitable for the treatment of partial seizures in patients 4 years of age and older.  Among more than a dozen antiepileptic drugs currently marketed in China, Lacosamide is the first third-generation antiepileptic drug to be marketed, and it is the fourth antiepileptic drug with suitable dosage forms for children.  A number of lacosamide tablets have been marketed in China, and there is no marketed dosage form of oral solution.

Compared with the tablets, the Lacosamide oral solution submitted by our company has  clear clinical value and advantages for special populations with dysphagia (such as children), is convenient to adjust the dosage flexibly according to patient's weight, and has a good taste, which can greatly improve the patient's compliance. 

Epilepsy affects about 50 million people worldwide, resulting in more than 13 million disability-adjusted life-years, accounting for more than 0.5% of the global burden of disease, and children under the age of 18 account for more than 60% of all epilepsy patients.  In 2018, the global market for antiepileptic drugs reached 150 billion RMB, of which Lacosamide was the third largest antiepileptic drug in the world with a global sales volume of 12.2 billion RMB, and the largest variety of antiepileptic drugs in the United States.  The market size of antiepileptic drugs in China is about 2 billion RMB, in an obvious growing trend, with a promisingly large  market potential.

Shenzhen Beimei Pharmaceutical Co., Ltd.

09-Jun-2020