FDA OK’s Taipei-based company’s submissing for Naldebain in U.S.

Lumosa Herapeutics said Monday that the FDA has confirmed its submission of the NDA of LT1001 Naldebain 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.

A Taipei-based Lumosa said it has engaged Camargo Pharmaceutical Services for regulatory consulting and strategic development services for 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,” said 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.”

Ken Phelps, President and CEO of Camargo Pharmaceutical Services said that Camargo’s goal is to guide its clients in the most cost- and time-effective manner through the 505(b)(2) regulatory pathway, while driving commercial success for its client-partners. “We look forward to continuing work with Lumosa to advance their long-acting solution for pain to benefit patients worldwide,” said Phelps.