Quivive Pharma, a biopharma company developing next generation opioid therapies, has entered into service agreements with Camargo Pharmaceutical Services to provide regulatory consulting and strategic development services for Quivive’s pipeline of fixed-dose combination products using its abuse-deterrent technology platform. The first program will concentrate on an abuse-deterrent immediate-release 505(b)(2) combination of hydrocodone and an approved respiratory stimulant. 

Camargo specializes in drug and combination device product development and approval using the regulatory pathway provided for in Section 505(b)(2) of the U.S. Federal Food, Drug, and Cosmetic Act and similar global processes.

“As a practicing anesthesiologist for 28 years, I have seen the dangers of opioid overdose and drug-induced respiratory depression firsthand,” said Quivive Pharma chief executive officer, John Hsu. “Quivive is the first company to specifically focus on reducing or eliminating the dangers of respiratory depression in existing therapeutics based on the concept of functional antagonism via novel combination products. We are confident that we can make these critical medicines safer, and do so in a way that is both efficient and cost effective.”

“One longtime concern has been to find a way to prevent opioid abuse,” said Ken Phelps, chief executive officer of Camargo Pharmaceutical Services. “We are excited to work on this solution to the crisis and have a hand in the effort of saving many lives worldwide.”