Reckitt Benckiser announced May 19 that it is codeveloping what would be the first nasally administered naloxone-based therapy to treat emergency cases of opioid overdose from heroin or prescription painkillers.
|Reckitt Benckiser Pharmaceuticals CEO Shaun Thaxter|
U.K.-based Benckiser has the option to acquire all rights to the product from the Lexington, KY, nasal spray developer AntiOp upon FDA approval.
"Together, we are uniquely suited to bring this product to market and are excited about the potential to help the many patients each year who succumb to opioid overdose. Naloxone nasal spray is a strong, strategic fit to our portfolio further strengthening our capabilities to provide much needed treatment services for the chronic relapsing conditions of addiction," CEO of Benckiser's pharmaceuticals division Shaun Thaxter said in a statement.
"I come from the state of Kentucky, which is the second worst state for opioid overdose," Daniel Wermeling, the CEO of AntiOp and professor at the University of Kentucky College of Pharmacy, told FierceDrugDelivery. Prescription opioids cause 16,500 deaths in the U.S. and opioid overdose is responsible for 800,000 ambulance runs per year, AntiOp said in a statement.
Some emergency personnel have been converting the injectable form of naloxone into a nasal spray using an atomizer device, Wermeling said. "The fact that they've been spraying naloxone in the nasal cavity tells me that there's a market opportunity," he explained.
The new formulation will be easier to administer than injected naloxone and reduce the risk of infection to medical personnel, Wermeling said, given that many heroin users carry HIV or hepatitis. He envisions the families of addicts keeping the nasal spray in their medicine cabinet, enabling them to administer the naloxone before emergency medical personnel arrive at the scene of an emergency.
The nasal spray has received widespread government support, according to an AntiOp statement. The FDA agreed to waive its $2 million new drug application fee and the National Institutes of Health is providing a three-year grant worth $3 million to help fund the initiative. Wermeling said company has obtained an IND, and needs to complete another clinical trial before filing for an NDA.
Wermeling said the naloxone will be delivered via a standard, commercially available nasal spray delivery device. The novelty lies in the nasally administered formulation. "Nasal delivery requires a much higher concentration of the active ingredient that is stable because the nasal cavity can't hold a large volume," he said.
Earlier this month, Benckiser entered into another co-development agreement to help bring Xenoport's ($XNPT) oral treatment for alcoholism to market. Reuters reports that the agreements may assist Benckiser's pharma unit obtain a better valuation in a possible spinoff.
Benckiser is best known for its consumer products, and was in discussions to purchase Merck's ($MRK) consumer health unit before it was acquired by Bayer.
- read Benckiser's release
- read AntiOp's release describing the new product and its status with the FDA
- here's Reuters' article about the agreement