Tarlige tablets approved in Japan for treatment of patients with neuropathic pain

In May 2021, Daiichi Sankyo had submitted a supplemental new drug application (sNDA) for Tarlige tablets based on results from a phase 3 trial in patients with CNP

Daiichi Sankyo announced that it has obtained approval in Japan to change the indication of the analgesic Tarlige tablets (mirogabalin besilate) from “peripheral neuropathic pain” to “neuropathic pain.”

Neuropathic pain is pain caused by lesions or diseases of the somatosensory nervous system and is classified into peripheral neuropathic pain and central neuropathic pain (CNP), according to the anatomical location of the nerve damage site that causes the pain. CNP is pain that arises from central nerve injury or impairment such as spinal cord injury and central post-stroke pain.

In May 2021, Daiichi Sankyo submitted a supplemental new drug application (sNDA) for Tarlige tablets based on results from a phase 3 trial in patients with CNP. By delivering a new therapeutic option for CNP, Daiichi Sankyo hopes to contribute to the healthcare of patients.

Tarlige is an analgesic proprietarily discovered by Daiichi Sankyo that works by inhibiting excessive release of pain-related neurotransmitters in the presynaptic nerve terminal. Tarlige was approved for the indication of “peripheral neuropathic pain” in Japan in January 2019 and was launched in April of the same year.