FDA Designates Opioid Overdose Treatment for Fast Track Development Program
Milestone accelerates AntiOp’s path toward approval and commercialization
LEXINGTON, Ky.--(BUSINESS WIRE)--A Kentucky company headed by a recognized expert in nasal delivery of medication says its intranasal naloxone spray, a drug designed to treat opioid overdoses, has received Fast Track designation from the Food and Drug Administration (FDA).
“and we are proud to have them on our team.”
The Fast Track program of the FDA is designed to expedite the development and review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track-designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process. AntiOp and the FDA may also be able to employ additional tools to expedite the FDA review process such as “rolling submission,” whereby AntiOp may submit portions of the new drug application (NDA) in a staged NDA submission process.
“The FDA has been very supportive of how we are developing our technology,” said AntiOp founder and CEO Daniel Wermeling. “This Fast Track designation, combined with our recent collaboration with Reckitt Benckiser Pharmaceuticals Inc., validates our vision and belief that this drug has the potential to fulfill an unmet medical need in the U.S.” The latest data from the CDC, for 2011 data, demonstrated that the national opioid overdose death rate continues to climb. A new ready-to-use, needle-free, naloxone delivery system may provide medical providers and their patients more options to rescue a loved one.
“We view the FDA decision to grant Fast Track designation to AntiOp for intranasal naloxone as an exciting and positive first step toward accelerating the commercialization of a simple, ready-to-use treatment needed to address the growing epidemic of opioid overdose,” said Shaun Thaxter, CEO, Reckitt Benckiser Pharmaceuticals Inc.
Wermeling added that the company has received continuing support from the National Institutes of Health and its National Institute on Drug Abuse (NIDA), which recently approved grant funding of $1 million annually for three years to advance development of AntiOp’s naloxone spray. Total federal and state grant funding to date exceeds $5 million, almost $4.5 million of that from the NIDA.
In addition, the Kentucky Economic Development Cabinet has provided AntiOp with development funding. Wermeling added that the University of Kentucky Colleges of Pharmacy and Medicine and the National Institutes of Health Center for Clinical and Translational Science have provided critical support to AntiOp.
“We have had tremendous help from so many organizations and individuals who are motivated by the great potential of this product,” Wermeling said, “and we are proud to have them on our team.”
Deaths due to opioid overdose have tripled since 1990, according to the Centers for Disease Control and Prevention (CDC). The CDC’s most recent data reveal approximately 16,500 deaths occur in the U.S. each year from prescription opioids. Studies have shown that approximately 800,000 ambulance runs occur each year in the U.S. in response to suspected opioid overdoses, involving both prescription medications and heroin. Commonly prescribed opioid painkillers include hydrocodone, methadone, oxycodone and oxymorphone.
Naloxone injection is FDA-approved and is already stocked in thousands of emergency rooms, ambulances and post-surgery recovery rooms for the treatment of opioid overdose. It must be administered intravenously or as an injection into muscle or under the skin. Because many heroin abusers carry hepatitis or the HIV virus, the risk of infection to medical personnel with an accidental needle puncture is high. To avoid this risk, some emergency responders use nasal atomizers to crudely convert the injectable form of naloxone to a nasal spray. Wermeling and others believe a ready-to-use nasal spray version of naloxone fulfills an unmet medical need.
AntiOp’s innovative solution is an easy and ready-to-use, disposable naloxone nasal spray. This spray product combines a proven device with a stable, concentrated naloxone solution specifically formulated for nasal delivery.
ABOUT ANTIOP, INC.
AntiOp, Inc. is a specialty pharmaceutical company working to develop naloxone nasal spray for the treatment of suspected opioid overdose. Founder and CEO Dr. Daniel Wermeling is a professor of pharmacy at the University of Kentucky and has published extensive research on nasal drug delivery. He holds patents on pharmaceutical products and delivery systems, many of which are in active clinical development as investigational new drugs.