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Lumosa announces FDA acceptance of IND application for LT1001, an extended-release analgesic injection

The harms caused by the opioid epidemic has led to an ever-increasing need for a novel agent in pain management. The US FDA has accepted the IND (investigational new drug) application for LT1001 (brand name Naldebain®), a new extended-release analgesic injection developed by Lumosa Therapeutics (“Lumosa;” 6535.TWO). Lumosa will initiate the comparative bioavailability study shortly and complete the enrollment by mid-year 2020. The study will bridge the clinical data of LT1001 and its parent drug, nalbuphine, in the US. Subsequently, a confirmatory trial according to the 505(b)(2) pathway will be conducted before the submission of a new drug application (NDA) to the US FDA for marketing authorization approval.

Naldebain® was approved by the Taiwan Food and Drug Administration (TFDA) in March 2017. Through Lumosa’s marketing partner, AMed Co., Ltd., sales volume of the product has grown rapidly since its launch. Likewise, significant amount of clinical data has been accumulated since the product launch and the data further confirmed the efficacy of the product and attracted numerous prospective partners globally for licensing negotiations of the product.

To facilitate licensing negotiation and shorten the development time to market, Lumosa obtained consent from the US FDA in 2017 to allow the development of LT1001 through 505(b)(2) pathway, a development process with reduced number of human clinical trials required for the drug approval. The purpose of this subject pharmacokinetic bridging study for LT1001 in the US is to fulfill the pre-market confirmatory trial required under the 505(b)(2) guideline.

Using the information listed in the white paper “FDA Analysis of Long-Term Trends in Opioid Analgesic Products: Quantity, Sales, and Price Trends,” published by the US FDA in 2018, the prescription opioid sales volume in the US in 2015 was calculated to be US$ 7.1 billion by multiplying the total morphine milligram equivalent sold and the price per morphine milligram equivalent.

Lumosa anticipates the enrollment of the bridging study to be completed in the first half of 2020. In the meantime, licensing negotiation with potential US partners will take place in order to expedite the time to market for LT1001 and to compete in the US analgesics market. The completion of the bridging study would most likely speed up the licensing process.

LT1001 (Naldebain®), is the first extended-release analgesic injection in the world to offer 7-day pain relief for the management of moderate/severe post-operative pain. LT1001, a prodrug of nalbuphine, is a new drug originated and developed in Taiwan.  Nalbuphine has been marketed worldwide for decades and the accumulated clinical data provided solid support to LT1001’s safety. The low-addictive potential of nalbuphine plus comparable analgesic potency to that of morphine but without the associated side effects, these advantages significantly enhanced Naldebain®’s competitive edge over other opioids. Lumosa has obtained patent protection up to 2035 in the US, the patents in European Union, China, Japan and other major pharmaceutical markets are under review by the respective authorities.