Daiichi Sankyo Submits sNDA for Tarlige (Mirogabalin) to Treat Central Neuropathic Pain in Japan

May 14, 2021 /Bio ValleyBIOON/ -- Daiichi Sankyo recently announced that it has submitted a supplemental New Drug Application (sNDA) in Japan for Tarlige (mirogabalin) for an additional indication related to central neuropathic pain (CNP). In January 2019, Tarlige was approved in Japan for the treatment of peripheral neuropathic pain. Daiichi Sankyo will continue to provide new treatment options for patients with various types of pain.

Tarlige is a drug developed by Daiichi Sankyo for the treatment of chronic pain. It is believed to exert its analgesic effect by inhibiting the release of neurotransmitters in pain-related nerve endings.

This application for a new indication is based on the results of a Phase 3 clinical trial evaluating Tarlige for the treatment of central neuropathic pain (CNP) following spinal cord injury (SCI). The study enrolled 274 patients with CNP following SCI across Asia (Japan, South Korea, and Taiwan, China) and utilized a double-blind design to assess the efficacy and safety of mirogabalin versus placebo.

Primary endpoint results showed that the change in the mean daily pain score from baseline to Week 14 of treatment demonstrated that mirogabalin was superior to placebo, meeting the primary objective. Furthermore, no additional safety concerns were observed.

Chemical structure of mirogabalin (Image source: Wikipedia)

Spinal cord injury (SCI) is one of the leading causes of disability in modern society. Central pain typically develops weeks to months after the injury, predominantly at or below the level of injury, with an incidence rate ranging from 11% to 94%, making it one of the most common intractable complications of SCI. The typical characteristics of neuropathic pain following SCI include hypoesthesia, burning pain, and numbness, which often interfere with patients' daily activities and rehabilitation training. Furthermore, the substantial long-term costs for rehabilitation and nursing care significantly compromise their quality of life.

The active pharmaceutical ingredient of Tarlige is mirogabalin, an α2δ ligand developed by Daiichi Sankyo. Administered orally, it preferentially and selectively binds to the α2δ-1 subunit of voltage-dependent calcium channels (types 1 and 2) with significantly greater potency than pregabalin. These calcium channels are widely distributed throughout the nervous system across various regions of the body, mediating pain transmission and processing. Mirogabalin exhibits a unique binding profile and long-lasting effects. Mirogabalin belongs to the same drug class as gabapentin and pregabalin, known as gabapentinoids.

In January 2019, Tarlige (mirogabalin) 2.5 mg, 5 mg, 10 mg, and 15 mg tablets were approved in Japan for the treatment of peripheral neuropathic pain (PNP). Generally, the initial dose for adult patients is 5 mg, administered orally twice daily. Thereafter, the dose may be gradually increased by 5 mg at intervals of at least one week, up to 15 mg. The dosage may be appropriately adjusted between 10 mg and 15 mg, administered orally twice daily, according to age and symptoms. (Bioon.com)

Original Source: "Daiichi Sankyo Submits"application for Additional Indication of Mirogabalin in Japan