The first nasally administered naloxone-based therapy to treat emergency cases of opioid overdose from heroin or prescription painkillers received a Fast Track Designation from the FDA, product developer AntiOp said in a July 15 statement.
"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.," said AntiOp founder and CEO Daniel Wermeling in a statement, referring to Reckitt Benckiser Pharmaceuticals' option to acquire all rights to the product upon FDA approval.
"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 of the U.K.'s Reckitt Benckiser, in a statement.
The new formulation will be easier to administer than injected naloxone and reduce the risk of infection to medical personnel since many heroin users carry HIV or hepatitis, Wermeling told FierceDrugDelivery. 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 due to overdose.
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 during the interview.
The statement says that the U.S. National Institutes of Health's National Institute on Drug Abuse recently gave AntiOp a grant of $3 million over three years to help develop the spray. In addition, FDA previously agreed to waive its $2 million new drug application fee. The agency's latest step means the drug-device combination product can receive expedited approval.
Prescription opioids cause 16,500 deaths per year in the U.S. and opioid overdose is responsible for 800,000 ambulance runs per year, AntiOp said in the statement. The FDA has been criticized for its approval of the painkiller Zohydro, which critics say will fuel prescription drug addiction because it is the first extended-release oral formulation of hydrocodone without acetaminophen; Massachusetts tried unsuccessfully to ban the drug.
Although the FDA stood firm on its Zohydro decision, the Fast Track Designation shows that it still takes the problem of prescription painkiller and drug abuse seriously. AntiOp is based in Lexington, Kentucky--a state facing one of the nation's worst opioid abuse epidemics.
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