According to Kentucky-based AntiOp, the company has received Fast Track designation from the FDA for its intranasal naloxone for the reversal of opioid overdose. The company is co-developing the unit-dose nasal spray, its only product, with Reckitt Benckiser and has received approximately $4.5 million in grant funding from the National Institutes of Health and its National Institute on Drug Abuse (NIDA) for development of the product.
AntiOp Founder and CEO Daniel Wermeling commented, “The FDA has been very supportive of how we are developing our technology. 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 US.”
Reckitt Benckiser CEO Shaun Thaxter said, “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.”
Lightlake Therapeutics is also developing intranasal naloxone for the reversal of opioid overdose with support from NIDA and recently announced that it had signed a manufacturing contract. Lightlake has indicated that it plans to submit an NDA by the end of 2014.
Read the AntiOp press release.
