• A Novel Solution for the Opioid Epidemic
  • Pain Relief Without Respiratory Depression

OPIOID EPIDEMIC

In 2015, 91 People Died Each Day in the US From Opioid Overdose, Comparable to the Number from Car Accidents or Gun Violence

THE CRISIS

THE CHALLENGE

All opioid analgesics induce respiratory depression, which is invariably the cause of death in cases of opioid overdose.  In 2015 in the US, 91 people died each day from opioid overdose, comparable to the number from car accidents or gun violence.  More than half of these deaths were from legal prescription opioid pain killers (eg. hydrocodone and oxycodone).  The US economic burden of this crisis is estimated to be greater than $78 billion annually.

Many new abuse-deterrent opioids have been approved in recent years, but all are abuse deterrent formulations (ADF) of extended release (ER) products marketed to a small number of pain specialists at premium pricing.  These ER/ADF products represent only a small fraction of the opioids consumed nationally, while generic immediate release (IR) products represent 90% of the opioid prescriptions written in the US today.  The low rate of reimbursement for these generics is a major disincentive to investment in abuse deterrent technologies, and thus NO abuse deterrent IR products are on the market today.

OUR TECHNOLOGY

A Safer Abuse Deterrent Replacement for Generic IR Opioids
(90% of Rx Opioid Prescriptions in US) with a Cost Effective Alternative

THE SOLUTION

INTELLECTUAL PROPERTY

The Quivive answer is to combine generic IR opioids with a generic respiratory stimulant (RS) using a regulatory approach known as the 505(b)(2) submission, which affords an accelerated path to regulatory approval.  The RS 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.  These products will be combined into a simple fixed dose tablet without complex or in-licensed technology, ensuring a low cost of goods that will support competitive pricing and acceptance and reimbursement by third party payers.

Quivive has confirmed proof of concept in animal studies and a strong IP position, with published USPTO & WO-PCT applications and additional filed provisionals.  These applications cover the fixed-dose combination of all currently approved opioids, benzodiazepines, barbiturates, and sleeping pills with any/all currently approved respiratory stimulants for delivery by oral or non-parenteral routes – ie. a platform for a future pipeline of dozens of drugs that are both abuse deterrent and safer than current options.

OUR TEAM

Quivive Pharma has assembled an experienced team of entrepreneurs, drug development experts and key advisors:

The visionaries behind Quivive.

Industry leaders with proven track records.

Our partners share our commitment to bringing novel products to market.

Field specific experts with cutting edge knowledge.

 

FOUNDERS

John Hsu, MD - Chief Executive Officer

Entrepreneur, practicing anesthesiologist

 

Peter Rix, DABT - Chief Scientific Officer

25 yrs drug development; Allergan, Ligand, Aragon, Seragon

 

Peter Weinstein, PhD, JD

Patent Attorney, IP, Legal Counsel

KEY ADVISORS

Robert Rappaport, MD

Former Director of DAAAP at FDA

 

Lynn Webster, MD

Clinical Pain Specialist & Past President of the American Academy of Pain Medicine

 

Joseph Cotten, MD, PhD

Clinical / Anesthesiology, Assistant Professor Harvard Medical School, Mass General

 

Mark Wiggins, MBA

Commercial Strategy & Corporate Development

 

Thomas Studebaker, MBA

Business Development

LEAD CONSULTANTS

Ryan Turncliff, PhD

Clinical Development

 

Gary K. Barnette, PhD

Regulatory Affairs

 

Jason Brittain, MS

Drug Product Manufacturing

 

PARTNERSHIPS

Carmago Pharmaceutical Services

 

 

Quivive has partnered with Camargo Pharmaceutical Services (a global leader in 505(b)(2) applications to US-FDA) for the co-development of Quivive's first product.

 

 

NEWS & EVENTS

EVENTS

Presentation at BIO 2017 , San Diego, California

June 21, 2017

 

 

PRESS RELEASES

Quivive Pharma Partners with Camargo Pharmaceutical Services for Development Programs - May 2, 2017

 

http://www.prnewswire.com/news-releases/quivive-pharma-partners-with-camargo-pharmaceutical-services-for-development-programs-300451537.html?tc=eml_cleartime

 

INVESTORS

Quivive Pharma is Developing a Practical, Low Cost Solution to the Opioid Epidemic with a Safer Generation of Abuse-Deterrent Analgesic Products

THE MARKET

THE BUSINESS MODEL

Generic IR hydrocodone + acetaminophen (Vicodin, Norco, Lortab, etc.) was the most prescribed drug in the US in 2013, with 137 million prescriptions written for hydrocodone containing products that year.  Generic oxycodone is the second most prescribed opioid in the US and gaining fast due to recent DEA rescheduling of hydrocodone from Category III to II.  Thus, a safer abuse deterrent replacement for these products would address a very large US market.

 Quivive’s strong IP will support development of a platform of safer and abuse deterrent products wherever respiratory depression is a concern.  The first product (QEV-817), will be a safer IR hydrocodone/acetaminophen analgesic, to be followed by development of an IR oxycodone product.  Development of other combination products will be initiated as appropriate.

For more information, please contact:

 

Thomas L Studebaker, BS, MBA

thomas.studebaker@quivivepharma.com

Office: (619) 729-7070

CONTACT US

3525-701 Del Mar Heights Road

 

San Diego, California 92130

 

info@quivivepharma.com

 

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