Anti-overdose nasal spray on FDA fast-track

An anti-overdose drug nasal spray has been submitted for expedited review by the Food and Drug Administration (FDA)

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.