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Daiichi Sankyo, a Japanese drug company, recently announced that a Phase 3 study to assess the treatment of central nervous pathological pain (CNP) after Tarlige 's treatment of spinal cord injury (SCI) has reached its main end point.
the study was conducted in 274 patients with post-spinal cord injury in Asia (Japan, South Korea, Taiwan, China) with central neuropathic pain, the efficacy and safety of mirogabalin and placebo were assessed in a double-blind manner.
the study's main endpoint results showed that changes in average daily pain scores from baseline examination to medication showed that mirogabalin outperformed placebo and achieved its primary goal.
addition, no additional security issues were observed.
detailed results of the study will be published in academic conferences and publications.
will continue to offer new treatment options for different patients with pain.
mirogabalin molecular structure (Photo: Wikipedia) Spinal cord injury (spinal cord injuries, SCI) is one of the most disabling diseases in modern society.
central pain usually occurs within weeks or months after spinal cord injury, mostly in the spinal cord injury plane or below, the incidence rate is 11% to 94%, is one of the most common stubborn complications of SCI.
The typical characteristics of neuropathic pain after spinal cord injury are sensory loss, burning pain and numbness, which often affect the daily activities and rehabilitation training of patients, and the subsequent rehabilitation and nursing expenses are huge, seriously reducing their quality of life.
Tarlige's active pharmaceutical ingredient is mirogabalin, an alpha-2 ligation created by the first three co-creations that, through oral administration, prioritize and selectively combine voltage-dependent calcium channels (1 and 2 The alpha-2-1 sub-units, but significantly more potency than pregabalin, these calcium channels are widely found in the nervous system in various areas of the body to mediat pain transmission and treatment, mirogabalin has a unique binding properties and long-lasting effect.
mirogabalin is in the same drug category as gabapentin and Pribarin.
January 2019, Tarlige (mirogabalin) 2.5mg, 5mg, 10mg and 15mg tablets were approved in Japan for the treatment of peripheral neuropathic pain (PNP).
, the initial dose for adult patients is 5 mg, 2 times a day orally, followed by a gradual increase of 5 mg at intervals of at least one week until 15 mg.
dose can be adjusted according to age and symptoms between 10 mg and 15 mg, 2 times a day orally.
original source: Daiichi Sankyo Announces Phase 3 Study Results of mirogabalin of central neuropathic pain afteral cord injury