Under the deal, Reckitt will have the option to acquire all rights to the product upon receipt of regulatory and marketing approval. The nasal spray is currently in clinical development stage with an active IND with the US FDA, which has offered the drug a priority review and said it would waive the $2m NDA (new drug application) fee.
AntiOp previously said the nasal spray, which can forego efficacy and toxicology studies since the treatment is already marketed, could hit the market within 18 months.
The possibility of using a nasal spray is unique and may be attractive for doctors and emergency technicians looking to treat the growing epidemic of opioid prescription painkillers and heroin in the US. The standard drug delivery method is an injectable form of naloxone.
Shaun Thaxter, CEO, Reckitt Benckiser, said, "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."
Opioid-related drug overdose deaths have more than tripled in the past 12 years, driven primarily by the abuse of opioid prescription painkillers.
Drug delivery
Kentucky-based AntiOp's nasal formulation is a pre-filled, unit-dose, disposable delivery system designed for insertion into the nose of an overdose victim to administer naloxone across the nasal mucosal membrane for absorption.
AntiOP has had strong support from the US National Institutes of Health and its National Institute on Drug Abuse (NIDA), which granted $1m annually for the next three years to advance development of AntiOp’s naloxone spray. Total federal and state grant funding to date exceeds $5m, almost $4.5m of that from the NIDA.
This product aims to fulfill an unmet need by providing family members and caregivers with a nasal alternative with AntiOp expertise.
AntiOp CEO Daniel Wermeling declined a request for comment.