GSK's CNS Drug Lamotrigine Dispersible Tablets Approved in China for New Indication in Bipolar Disorder

On March 3, GlaxoSmithKline (GSK) issued a press release announcing that the National Medical Products Administration (NMPA) of China had approved the new indication application for Lamictal (generic name: lamotrigine dispersible tablets). The drug is indicated for preventing recurrence or relapse of mood episodes in adult patients with bipolar disorder. Lamictal is a classic central nervous system therapeutic agent from GSK and had previously been approved in China for the treatment of epilepsy.

Bipolar DisorderBipolar disorder is a condition that causes severe fluctuations in mood, energy levels, and the ability to perform daily activities. Patients may exhibit extreme manic and depressive episodes. Management typically involves pharmacotherapy, psychotherapy, supportive care, and non-pharmacological somatic treatments. Clinically, there is a lack of medications capable of simultaneously controlling both manic and depressive symptoms.

Lamotrigine is a voltage-gated sodium channel blocker. In cultured neuronal cells, it suppresses repetitive firing and inhibits the pathological release of glutamate—an amino acid that plays a key role in the genesis of seizures—and also inhibits bursts of action potentials induced by glutamate.

Results from two international Phase III clinical trials in bipolar disorder showed that, compared with placebo, lamotrigine significantly delayed the time to intervention for any mood episode by up to 197 days, with efficacy similar to that of lithium. Unlike lithium, lamotrigine significantly delayed the time to intervention for depressive episodes compared with placebo. These efficacy data have led numerous guidelines both within and outside China to recommend lamotrigine as a first-line treatment for bipolar disorder.

According to the press release, the approval of GSK’s lamotrigine dispersible tablets for a new indication in bipolar disorder will provide more treatment options for such patients, thereby helping to improve their quality of life and prognosis.

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