Taipei, Taiwan-based Lumosa Therapeutics Co., Ltd., a company focused on developing treatments for neurological and inflammatory disease, announced recently that it had engaged Cincinnati-headquartered Camargo Pharmaceutical Services for regulatory consulting and strategic development services for LT1001 (Naldebain®, dinalbuphine sebacate IM injection) in the US.
Naldebain® IM injection has received market authorization and launched in Taiwan as the world’s first 7-day long-acting analgesic injection for moderate to severe post-operative pain.
The company also noted that the US FDA had confirmed that the 505(b)(2) regulatory pathway is appropriate for the NDA submission of LT1001 in the US.
“There has been a significant growth in the rate of abuse, misuse, and overdose of opioid analgesics corresponding to the increase in the use of these drugs in recent years. Safe use of traditional opioids is a great concern of the medical and regulatory community,” says Lumosa President and CEO, Dr. Wendy Huang. “Naldebain’s active ingredient, nalbuphine, is formulated in a depot formulation and offers lasting pain relief of opioid potency with little risk of abuse and respiratory depression. With Camargo’s guidance, the 505(b)(2) pathway will allow Lumosa to accelerate the development and registration of Naldebain in the US, offering extended pain relief for patients and easing the safety concern of care providers.”
“Camargo’s goal is to guide our clients in the most cost- and time-effective manner through the 505(b)(2) regulatory pathway, while driving commercial success for our client-partners,” said Ken Phelps, President and CEO of Camargo Pharmaceutical Services, which specializes in the 505(b)(2) approval pathway and global equivalent processes. “We look forward to continuing work with Lumosa to advance their long-acting solution for pain to benefit patients worldwide.”
Lumos’s pipeline currently consists of Naldebain®, a long long-acting analgesic injection, and LT3001, an NCE for the treatment of acute ischemic stroke. Naldebain® has received Taiwan FDA (TFDA) approval and launched in Taiwan in the Spring of 2017. LT3001 is under phase I clinical trial in the US.
(News provided by Lumosa Therapeutics)