[PRESSWIRE] TAIPEI, Taiwan and CINCINNATI, Aug. 28, 2017 -- Lumosa Therapeutics Co., Ltd. ("Lumosa"), a Taipei-based biopharmaceutical company developing innovative therapies focused on the treatment of neurological and inflammatory disease, announced today the FDA has confirmed the 505(b)(2) regulatory pathway is appropriate for the submission of the NDA of 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. Lumosa has engaged Camargo Pharmaceutical Services, LLC ("Camargo") 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," 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. "We look forward to continuing work with Lumosa to advance their long-acting solution for pain to benefit patients worldwide."
About Lumosa Therapeutics
Lumosa Therapeutics, a publicly traded company in the Taipei Exchange, is dedicated to the development of innovative new drugs for the treatment of neurological and inflammatory diseases of unmet medical needs. The company is actively engaged in scientific in-licensing and new drug development under the "reSEARCH and DEVELOPMENT" model. This model is executed by a highly capable and experienced cross-functional teams of translational research, CMC, preclinical, clinical development, project management, regulatory affairs, intellectual property and business development experts. Current major products in Lumosa's pipeline are Naldebain®, a long long-acting analgesic injection, and LT3001, an NCE for the treatment of acute ischemic stroke. Naldebain® has received TFDA approval and launched in Taiwan in the Spring of 2017. LT3001 is under phase I clinical trial in the US.
About Camargo Pharmaceutical Services
Camargo Pharmaceutical Services is the most experienced team of experts providing comprehensive drug development services specialized for the 505(b)(2) approval pathway and global equivalent processes. By assessing the scientific, medical, regulatory, and commercial viability of product development opportunities, Camargo systematically builds and executes robust development plans that align with business strategies and ensure Agency buy-in every step of the way. With alignment through pre-Investigational New Drug (pre-IND) meeting planning and preparations, Camargo maintains and ensures consistency throughout the drug development program, which increases the likelihood of NDA and future market success. Routinely holding three to six pre-IND meetings a month, Camargo works with product developers across more than 25 countries. For more about Camargo Pharmaceutical Services, visit http://camargopharma.com