Pharmaceuticals - San Diego, California, United States
Quivivepharma is a drug development company that has pipeline for 20-25 of drugs based on innovative intellectual property that has the potential to cause a paradigm shift in the treatment of pain.In 2000, govenment policy that declared pain to be the "5th vital sign". Uncontrolled access to controlled subtances resulted and fatal overdosing became an epidemic and then a national emergency. 116 people a day fatally overdose on opioids (CDC2016) and this number is widely known to be underestimated (CDC 2017). There are over 48 million surgeries per year and most require opioids to treat postoperative pain. There are 100 million people who take opioids daily, 21.5 million who have an opioid use disorder, 2.1 million who abuse opioids, and over 42,000 people who fatally overdose on opioids. All of these patients are at risk for an accidental or intentional opioid overdose. All opioids agonize the mu receptor and can cause respiratory depression and death. All current treatments for the opioid crisis are for people already overdosed or addicted to opioids. We have to have opioids because there are no drugs to better treat pain than opioids. So although opioids have significant side effects including rashes, nausea, vomiting, constipation, decreased sex drive, addiction, respiratory depression and death, we simply treat the side effects. In the search for a solution no pharma company has sought to simply treat the opioid side effect of respiratory depression that causes death. Quivivepharma has created a prophylactic solution to prevent opioid induced respiratory depression and deter abuse. The Quivivepharma PATENTED solution is currently in the 505(b)2 approval path through the FDA which has provided a clear clinical path to approval and has offered fast track designation and an expeditied review. For Phase 1 we have a rodent-nonrodent safety toxcity study, a single ascending dose study and a multiple ascending dose study to complete which we expect to be completed by quarter 4 2018. Phase 2A will begin with a Human Abuse Liability Study.Our management team has a combined experience over 100 years in clinical medicaine including pain management, regulatory affairs, drug development, CMC and business development/commericalization. We have engaged the services of Robert Rappaport MD, former FDA director of DAAAP, Brian Harvey MD,PhD former FDA director of GI/Pain, Lynn Webster MD, Past President of the American Pain Society, and Camargo Pharmaceutical services.Quivivepharma with QEV-817 is poised to have patients "Live to Breathe".
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