Friday, May 05, 2017
Quivive Pharma, a San Diego-based biotechnology company developing next generation opioid therapies announced today that it has entered into service agreements with Camargo Pharmaceutical Services, LLC. Camargo will be providing regulatory consulting and strategic development services for Quivive's pipeline of fixed-dose combination products built upon its patented abuse-deterrent and misuse-prevention 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 is the most experienced global strategist specializing in drug and combination device product development and approval utilizing the regulatory pathway provided for in Section 505(b)(2) of the US Federal Food, Drug, and Cosmetic Act and similar global processes. Over the last decade, Camargo has established an unrivaled track record with 505(b)(2) IND and NDA preparations and submissions, including participation in more than 1100 Agency meetings and more than 200 FDA NDA and ANDA approvals.
As a practicing anesthesiologist for 28 years, I have seen the dangers of opioid overdose and drug-induced respiratory depression firsthand, says Quivive Pharma CEO, 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, says Ken Phelps, CEO 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.