Corporate
2016.08.31
LT1001 clinical results accepted by the Clinical Journal of Pain
After successful execution of the license agreement with Syntano Technology Venture for China in June, Lumosa Therapeutics Co., Ltd. (TPEx 6535), receives a notification from “the Clinical Journal of Pain” (CJP) that the manuscript on LT1001 Phase III trial results was accepted for publication. “The Clinical Journal of Pain” is an esteemed international journal ranked among top 10 of clinical journals in analgesic and anesthetic field. It publishes many medical articles addressing pain management in clinical setting and new treatment models etc. for the past 30 years. The acceptance by CJP indicated LT1001 is regarded as an innovative product in clinical pain management, which deserves the recognition by international medical experts.
In this Phase 3 trial, the efficacy of LT1001 was demonstrated by the pain intensity assessments made during Days 0‐2 and Days 0‐7 of the post‐hemorrhoidectomy period. Pain intensity scores reported by LT1001 Treatment group were statistically significantly lower than those of the Placebo group. Subjects in the LT1001 group also consumed much less oral analgesic during the study period. There were neither serious adverse events (SAE), nor unexpected adverse events (AE) related to LT1001 reported.
The clinical advantage of LT1001 is with its long‐acting analgesic effect. LT1001 not only offers an extended period of pain control, also greatly reduces the frequency of medical attention and dose administration. LT1001 improves patients’ quality of life, as well as shortens the time required for recovery and hospitalization. We believe LT1001 delivers great pharmaco‐economic value because it can significantly decrease the healthcare burden and minimize the complications associated with traditional analgesics.
The NDA for LT1001 is currently under review by the Taiwan FDA with market authorization anticipated in the spring of 2017. The publication in ”The Clinical Journal of Pain” can surely increase the confidence level of the medical practitioners in LT1001 as a new drug product. Upon its approval, LT1001 is expected to be the drug of choice for post‐operative pain.
In this Phase 3 trial, the efficacy of LT1001 was demonstrated by the pain intensity assessments made during Days 0‐2 and Days 0‐7 of the post‐hemorrhoidectomy period. Pain intensity scores reported by LT1001 Treatment group were statistically significantly lower than those of the Placebo group. Subjects in the LT1001 group also consumed much less oral analgesic during the study period. There were neither serious adverse events (SAE), nor unexpected adverse events (AE) related to LT1001 reported.
The clinical advantage of LT1001 is with its long‐acting analgesic effect. LT1001 not only offers an extended period of pain control, also greatly reduces the frequency of medical attention and dose administration. LT1001 improves patients’ quality of life, as well as shortens the time required for recovery and hospitalization. We believe LT1001 delivers great pharmaco‐economic value because it can significantly decrease the healthcare burden and minimize the complications associated with traditional analgesics.
The NDA for LT1001 is currently under review by the Taiwan FDA with market authorization anticipated in the spring of 2017. The publication in ”The Clinical Journal of Pain” can surely increase the confidence level of the medical practitioners in LT1001 as a new drug product. Upon its approval, LT1001 is expected to be the drug of choice for post‐operative pain.
