FDA approves Adapt Pharma’s Narcan nasal spray to treat opioid overdose

The spray, which is expected to be launched in early 2016, is an investigational drug designed to provide a dose of naloxone in a nasal spray formulation.

It is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.

The spray is intended for immediate administration as emergency therapy in settings where opioids may exist.

The company said the spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride.

Adapt Pharma chairman and CEO Seamus Mulligan said: "Narcan Nasal Spray a ready-to-use, needle-free device, delivers a 4 mg dose of naloxone in a single 0.1 ml nasal spray.

"This new device makes naloxone readily available for emergency use by a friend, family member or caregiver, as well as offering an alternative treatment option for first responders and healthcare providers."

Data from the Centers for Disease Control and Prevention suggests that opioid overdose resulted in about 24,500 deaths in the US in 2013, a four-fold increase from 1999.

About 76% of those deaths occurred in a non-medical setting, most frequently at home.

Image: Adapt Pharma expects to launch Narcan (naloxone hydrochloride) nasal spray in early 2016. Photo: courtesy of ADAPT Pharma, Inc.