Dec 12, 2016
Naldebain® Drew Attention at CRS
Dr. Chien-Yuh Yeh was invited to report the phase 3 trial results of Naldebain® (dinalbuphine sebacate) I.M. Injection (also called LT1001) at the Annual Meeting of Taiwanese Society of Colon and Rectal Surgeons held in Kaohsiung, Taiwan on December 10, 2016. The Society celebrated its 30th anniversary since inception. Speaker Dr. Yeh is a practicing surgeon at Chang Gung Memorial Hospital and one of the lead investigators of this phase 3 trial. The title of his presentation was “A Phase III Trial of a Novel Long Acting Painkiller,” which highlighted the unique safety and long-lasting efficacy profile of the product.
Chairman of Society, Dr. Hong Hua Chen, expressed his excitement with the positive outcome of the trial and Society’s support to a novel analgesic product that has been developed by Taiwan's drug development company and to be first launched in Taiwan.
The study, titled "A Phase III Trial of a Novel Long Acting Painkiller," was conducted in six medical centers; including Tri-Service General Hospital, Chang Gung Memorial Hospital Keelung Branch, Chang Gung Memorial Hospital Linkou Branch, Chang Gung Memorial Hospital Chiayi Branch, Chang Gung Memorial Hospital Kaohsiung Branch, and Taichung Cheng Ching Hospital. Dr. Jeng-Yi Wang, honorary superintendent of Chang Gung Memorial Hospital, served as its Principle Investigator. Lumosa Therapeutics submitted the New Drug Application (NDA) of Naldebain® (dinalbuphine sebacate) I.M. Injection to Taiwan FDA in September 2015. The approval is expected in early 2017 and to be marketed by InteRx Biomedical Co.,Ltd. in Taiwan. Syntano Technology Venture - a Haike company, obtained the marketing right of LT1001 in China, Hong Know and Macau.
Source：Lumosa Therapeutics Co., Ltd.
http://www.lumosa.com.tw/en/News/Pipeline/Naldebain-LongTermAnalgesic-hemorrhoidectomy-LT1001