Formulation Patent of Naldebain App

New U.S. Patent Granted to Lumosa for Naldebain(R), a Long-acting Analgesic for Moderate to Severe Post-Operative Pain


 (January 23, 2018, Taipei) Lumosa Therapeutics Co., Ltd. (Lumosa; 6535.TWO) announced that the United State Patent and Trademark Office (USPTO) has issued a patent (US Patent No. 10,183,018 with an expiry date of September 27, 2035) on the proprietary formulation of Naldebain(R), which is a sustained release formulation of dinalbuphine sebacate approved for the treatment of moderate to severe post-operative pain. 


Mr. Rong-chin Lin, Lumosa’s President and CEO, pointed out the unmet and urgent need of a safe, long-acting analgesic that has little or no abuse risk like Naldebain. Naldebain is positioned to become a widely prescribed analgesic in the future, taking advantage of its safety profile (superior to other opioids) and 7-day analgesic effect. The issued formulation patent by the USPTO shall facilitate the out-licensing process in the United States and other regions in the world. The company is currently actively holding licensing discussion with several potential partners in other regions including the US. In addition to the US, the patent applications is under review in 20 jurisdictions; including major markets such as Europe, China and Japan.


Pain management is an important part of medical treatment. Well managed pain can reduce patient’s suffering and facilitate healing to prevent acute pain from progressing further to chronic pain, which consequently reduces the burdens of the healthcare professionals and caretakers. However, decades of increasing opioid misuse and abuse has led to the Opioid Crisis today where death due to overdosing has reached a staggering number. In August 2018, President Trump even called the US Justice Department to sue opioid manufacturers. Thus, there is a definite, unmet need for safer analgesics without abuse abusive potential.


Naldebain is a prodrug of nalbuphine, which is an analgesic with extensive safety track record. Seven-day analgesic effect of Naldebain is achieved through the proprietary extended-release formulation developed by Lumosa. The product was approved for marketing in Taiwan in March 2017 and was licensed to A+Med Co., Ltd. for sales and marketing in Taiwan. The monthly sales volume has increased over 300% since product launch in July 2017.


Lumosa assigned the marketing right of the product in China to Syntano Technology Venture, a subsidiary of HaiKe Chemical Group. Pivotal clinical trials for product registration in China are scheduled to be initiated in 2019.   


In early 2018 Lumosa further extended market potential of LT1001 in veterinary medicine by granting the rights to develop LT1001 for veterinary uses in the United States, Canada, Australia and New Zealand to Skyline Vet Pharma, an animal health product development company in the US specializes in reformulating proven human drugs for the use in companion animal veterinary medicine.




About LT1001

LT1001 (Naldebain®) is a safe, long-acting, easily administered analgesic injection. Through its prodrug design and proprietary sustained release formulation, the active ingredient, nalbuphine, is gradually released in the human body after intra-muscular injection to alleviate moderate to severe post-operative pain after administered pre-operatively.  Naldebain is a safe, effective, non-additive opioid analgesic with good safety profile. It may facilitate post-operative recovery, reduce concomitant analgesic medication, reduce the burden and risks of medical staffs. It improves the quality of life of patients and care-takers and offer higher pharmacoeconomics .



About Lumosa

Lumosa Therapeutics (Lumosa, Taipei Stock Exchange 6535), is a new drug R&D company focused on the development of novel drugs. Under the reSEARCH and DEVELOPMENT (rSD) model, the company in-licenses high potential translatable drug candidates to development novel new drugs for unmet medical needs. Value-added development programs are executed by its experienced cross-functional teams then out-licensed and/or partnered strategically to generate revenues. Lumosa focuses the development of small molecule new drugs and biologicals for diseases in the central nervous system, inflammation, and cancer areas. Major products in Lumosa’s pipeline include LT3001, an NCE for the treatment of acute ischemic stroke, ECC01, a fusion protein for the treatment of solid-tumors.





Spokesperson: Judy Juang

Phone No.: +886-2-26557918





  • Date January 23, 2019
  • Author Judy Juang
  • Source Lumosa Therapeutics