SAN DIEGO, May 4, 2017 /PRNewswire/ -- Quivive ('kee-veev') Pharma ("Quivive" or the "Company"), 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"). 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."
About Quivive's Intellectual Property
Quivive's patented technology platform combines generic immediate-release opioids with a generic respiratory stimulant (RS), which will be sub-therapeutic when used as directed, but will prevent death from respiratory depression following either accidental or intentional overconsumption. Abuse deterrence is achieved by aversion to unpleasant, but not dangerous, RS side-effects when excessive doses are consumed.
About Quivive Pharma
Quivive Pharma is a San Diego-based company developing revolutionary drugs to safely treat pain and prevent abuse and misuse. Quivive Pharma has assembled an experienced team of entrepreneurs, drug development experts, and key advisors including Dr. Robert Rappaport, the recently retired section chief at the FDA's department of anesthesia, analgesia and addiction products, and Dr. Lynn Webster, addictiologist and pain management physician, which enables development of a platform of newer and safer products wherever respiratory depression is a safety concern. For more information on Quivive Pharma, visit: http://quivivepharma.com
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