Daiichi Sankyo Korea has received approval from the Ministry of Food and Drug Safety for an additional indication for Taleaje (Ingredient: mirogabalin), a neuropathic pain treatment, in treating central neuropathic pain.

Taleaje had previously received approval to treat peripheral neuropathic pain in Jan. 2020.

Neuropathic pain occurs through a lesion or disease of the nervous system. It has two classifications -- peripheral or central neuropathic pain -- according to the anatomical location of the damaged nerve site causing the pain.

Central neuropathic pain can occur through damage to the central nerve, damage to the spine, or central post-stroke pain (CPSP).

The ministry approved the new indication based on phase 3 clinical trial conducted in Korea and other Asian countries in 299 patients with central neuropathic pain.

In the clinical trial, each patient received Taleaje or a placebo for 14 weeks.

As a result, the Taleaje-administered group showed a statistically significant improvement in pain score at 14 weeks compared to the placebo-administered group.

In the Taleaje-administered group, the frequency of adverse reactions was 41.1 percent, with common adverse reactions including drowsiness (25.8 percent), dizziness in (6.6 percent), and weight gain (4.6 percent).

Also, in a long-term open-label clinical trial conducted in Korea and other Asian countries for 52 weeks in 210 patients with central neuropathic pain, the treatment significantly reduced pain intensity compared to before administration.

“Neuropathic pain extremely degrades the quality of life of patients, causing a wide burden on the patient, family, and society,” Daiichi Sankyo Korea CEO Kim Dae-jung said. “As Taleaje can treat central neuropathic pain through this expanded indication, we hope that more patients will be able to help relieve pain caused by pain.”