An anti-overdose drug nasal spray has been submitted for expedited review by the Food and Drug Administration (FDA)
Daniel Wermeling, University of Kentucky pharmacy professor and founder of AntiOp
Daniel Wermeling developed the nasal spray version of the anti-overdose drug naloxone hydrochloride. The spray is the first of its kind to be submitted for approval to the FDA and is on a fast track for drugs that treat serious conditions.
Wermeling said: “This is just like an EpiPen, conceptually. The goal is to save time.”
Wermeling founded his company, AntiOp in 2009 after he recognised an unmet medical need for a needle-free delivery method of naloxone.
The drug has been approved since 1971 for delivery by injection, but paramedics and emergency departments commonly administer it off – label using a mucosal atomisation device that turns an injectable drug into a nasal spray.
The product pairs a reformulation of naloxone and an already-approved plastic nasal spray device reducing regulatory and development hurdles.
In May, Indivior, a pharmaceutical company specialising in drugs for addiction treatment, purchased the product.
Wermeling sees the increased availability of naloxone as a crucial frontline defence against overdoses from both prescription opioids and heroin.
