LEXINGTON, Ky.--(BUSINESS WIRE)--AntiOp, Inc., a Kentucky company founded by Dr. Daniel Wermeling, has signed an agreement with Reckitt Benckiser Pharmaceuticals, Inc. to accelerate production and worldwide marketing of intranasal naloxone, a drug designed to treat opioid overdose.
“This partnership leverages our combined resources and strengths,” Wermeling said. AntiOp has the technical expertise and R&D experience to deliver a specifically-designed nasal formulation of the drug, he added, while Reckitt Benckiser Pharmaceuticals, Inc. has resources and experience in developing therapies and working with payers and policy makers to make the life-saving drug available to patients worldwide.
The Centers for Disease Control’s recent statistics indicate a steadily increasing number of deaths due to opioid overdose. The number has tripled since 1990, with a more recent statistic citing 16,500 deaths in the U.S. from prescription opioids alone, principally painkillers such as hydrocodone, methadone, oxycodone and oxymorphone. Related statistics show approximately 800,000 ambulance runs in the U.S. each year related to suspected opioid overdoses involving both prescription opioids and heroin.
Naloxone injection is an inventory staple for thousands of emergency rooms, ambulances and post-surgery recovery rooms, and is produced and marketed by other pharmaceutical companies. Naloxone currently is injected intravenously, into muscle tissue, or under the skin. Emergency responders have used atomizers to crudely convert the injectable form of naloxone into a nasal spray. Wermeling’s innovative approach improves on this idea, enabling rescue treatment when the patient is unconscious. The nasal spray will be administered using a ready-to-use, single-use, delivery device which is inserted into the nose of an overdose victim, delivering a consistent dose absorbed across the nasal membranes even if the patient is not breathing. The product eliminates any use of needles for injection and is disposable.
“We’re very excited to be working with Reckitt Benckiser Pharmaceuticals, Inc. and look forward to substantially accelerated commercialization now that they are involved,” Wermeling said. Reckitt Benckiser Pharmaceuticals, Inc. has been a leader in opioid dependence treatment for more than a decade, he added. Under the terms of the agreement, Reckitt Benckiser Pharmaceuticals, Inc. and AntiOp will co-develop the nasal naloxone spray through the time of regulatory approval. Wermeling is confident that they will meet eligibility requirements for FDA priority review after the new drug application is filed.
While the approach offers advantages over injection, there is still opportunity for fine tuning and design optimization, Wermeling said. “We need to hear from end users and stakeholders about the serviceability of the product. Their input will critically impact second-generation product development. Ultimately, we’re creating intranasal naloxone to serve them, and we are striving to assist in developing the standard of care in opioid overdose cases.”
Development funds have been provided by the National Institute on Drug Abuse and the Kentucky Science and Technology Corporation. “We are very grateful for the early-stage funding from NIDA and KSTC, which enabled us to complete proof-of-concept research and development for naloxone nasal spray,” Wermeling said. “We also take great pride in recognizing our relationship with the University of Kentucky Colleges of Pharmacy and Medicine and the National Institutes of Health Center for Clinical and Translational Science, whose faculty and resources were critical to our early-stage success.”
The product is entering its final clinical trial in June.
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.