FDA puts spray on clear regulatory path to approval
September 20, 2013 09:00 AM Eastern Daylight Time
LEXINGTON, Ky.--(BUSINESS WIRE)--AntiOp, Inc., a Kentucky company headed by a renowned expert in nasal delivery of medication, says its nasal spray could save the lives of thousands of narcotic pain medication and heroin overdose victims and that the Food and Drug Administration (FDA) has specified the final research requirements necessary for approval of the drug. With sufficient funding, AntiOp, Inc. says, its naloxone nasal spray could be on the market in about 18 months.
"We have strong support for our approach from a number of crucial stakeholders"
"The FDA has been very encouraging of our approach," said AntiOp founder and CEO Dr. Daniel Wermeling. "Once we file a new drug application, they plan to complete a priority review of our product, which usually takes about six months."
Wermeling added that the company has strong 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 the next 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.
Overdosing of prescription pain medications known as "opioids" has reached epidemic proportions, according to the Centers for Disease Control and Prevention (CDC). The CDC's most recent data point to some 16,500 deaths 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 is already stocked in thousands of emergency rooms, ambulances and post-surgery recovery rooms but in an injectable form. It must be administered intravenously or as a shot into muscle or under the skin. Because many heroin abusers carry hepatitis or the HIV virus, the risk of infection to medical personnel is high. Some emergency responders use atomizers to convert the injectable form of naloxone to a nasal spray. Wermeling and others believe a nasal spray version of naloxone will prove to be effective, safer and easier to administer than the current injection-based approach.
In fact, the Substance Abuse and Mental Health Services Administration suggested in August that physicians should consider co-prescribing naloxone to patients for whom they prescribe significant levels of opioids and have at least one risk factor for overdose.
AntiOp's solution is a single-dose, disposable naloxone nasal spray that combines a commercially marketed and proven nasal spray device with a stable, concentrated naloxone solution specifically formulated for nasal delivery. The company filed an investigational new drug (IND) application in 2012 and data were subsequently submitted to the FDA. In response, the FDA this year provided AntiOp with a clear regulatory path to approval.
Testing continues and the FDA will waive the usual $2 million new drug application fee. Efficacy and toxicology studies are not required since naloxone is already on the market. Wermeling said the company is seeking an additional $5 million-$7 million to accelerate the development of the spray and be the first on the U.S. market.
Karl Sporer, Professor Emeritus at the University of California, San Francisco's Department of Emergency Medicine, said he expects AntiOp's naloxone spray will perform better than the existing standard of care – an injection or nasal spray via atomizer device – for opioid overdoses. Sporer, a consultant to AntiOp, is an emergency physician who managed three emergency medical systems over 14 years in San Francisco and Northern California.
"We have strong support for our approach from a number of crucial stakeholders," Wermeling said. "We're very confident that our approach will prove to be highly effective and will soon become the standard of care in opioid overdose situations."
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.
Dr. Daniel Wermeling, 859-221-4138