GSK wins approval for the dispersible tablet formulation of its innovative anti-epileptic drug Lamictal in China

GSK announced today that the dispersible tablet formulation of Lamictal (lamotrigine dispersible tablet), its drug for treating epilepsy, has been approved by the NMPA for launch, to be used for children two years of age and above, adults and the elderly.

As an upgrade of Lamictal conventional tablet, Lamictal dispersible tablet features broad indications, different dose strengths and more accurate, lower starting dosage. Available in black currant flavour, it also improves patient compliance1,2.

Lamictal dispersible tablet is indicated for a wider range of patient age groups including children two years of age and above, adults and the elderly3.Furthermore, the conventional tablets and the new dispersible tablets can also be interchanged without the need for re-titration4.

There are currently more than 50 million epilepsy patients worldwide5. The disease incidence is relatively high in children and adolescents and is already on the rise among the elderly6. In China, epilepsy is the second most prevalent neurological disease, after stroke, and it severely affects the patients’ physical and mental health as well as quality of life. More important than just controlling seizures, effective epilepsy treatment aims to improve the quality of life of patients6.

As a second-generation novel epilepsy treatment, Lamictal is both effective and safe. It has been used worldwide for more than 28 years, and benefited more than 10 million patients. It is, in fact, the first-line drug in the treatment of epilepsy for partial seizures and generalised seizures as recommended by UK’s NICE guidelines, the US AAN/AES guidelines, the SIGN guidelines in Scotland and China’s clinical guidelines on epilepsy diagnosis and treatment6,7,8,9.A significant amount of clinical research has proven that Lamictal is highly effective and safe in controlling partial seizures, generalised seizures, and seizures associated with Lennox-Gastaut Syndrome.

Dr. James He, VP, Head of Medical Affairs of GSK China, said, “The approval of lamotrigine dispersible tablet in China will dramatically enhance medication convenience for epilepsy patients in China. We believe that it will also significantly improve the patients’ prognosis, which is in line with GSK’s core value of patient focus. GSK will continue to introduce to China more high-quality, innovative drugs to benefit Chinese patients.”?

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References:

  1. WHO.Disintegrating Tablets. https://www.unicef.org/supply/index_53571.html
  2. Dispersible tablets benefits
  3. 拉莫三嗪分散片中国说明书
  4. Wangemann M,et al. In vivo biopharmaceutical characterisation of a new formulation containing the antiepileptic drug lamotrigine in comparison to plain and dispersible/chewable lamotrigine tablets. Arzneimittelforschung. 2005;55(6):307-11
  5. WHO.Epilepsy.http://www.who.int/news-room/fact-sheets/detail/epilepsy
  6. 中国抗癫痫协会. 临床诊疗指南(癫痫病分册). 人民卫生出版社. 2015
  7. National institute for health and care excellence. Epilepsies: diagnosis and management.2012.
  8. Kanner A M, et al.Neurology, 2018: 10.1212/WNL. 0000000000005756.
  9. Healthcare improvement Scotland. Diagnosis and management of epilepsy in adults.2015