Lumosa Announces FDA Acceptance of IND Application for LT1001, an Extended-Release Analgesic Injection - Lumosa to Initiate the Bridging Study in the US

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Lumosa Announces FDA Acceptance of IND Application for LT1001, an Extended-Release Analgesic Injection - Lumosa to Initiate the Bridging Study in the USOpioid misuse, addiction, and overdoses have caused significant social and economic burdens leading to the opioid crisis. LT1001 (brand name Naldebain®) is a prodrug of nalbuphine, an abuse-free analgesic that has been marketed worldwide for decades. Naldebain® is developed by Lumosa Therapeutics ("Lumosa;" 6535.TWO) as the world's first extended-release analgesic injection for the relief of moderate/severe post-operative pain for 7 days without the side effects associated with opioids. Naldebain® was approved by the Taiwan Food and Drug Administration (TFDA) in March 2017. A considerable amount of clinical data and use experience have accumulated since product launch. With confirmed safety and efficacy data of over 20 thousand users, Naldebain® is an attractive pain management solution for the opioid crisis.


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