Nasal-spray version of overdose reversal drug wins FDA approval

The Food and Drug Administration (FDA) has approved a nasal-spray formulation of the opioid overdose reversal drug naloxone—a version expected to be easier for first responders and the public to administer than injectable formulations of the medication.

The National Institute on Drug Abuse (NIDA) announced Nov. 18 that Adapt Pharma Limited, a partner of Lightlake Therapeutics, will market the newly approved formulation as Narcan Nasal Spray. NIDA had announced in June that the nasal-spray formulation would be subject to a rolling review in order to expedite the approval process.

Lightlake and NIDA in 2013 entered into an agreement for the application of new technology toward creating a life-saving intervention for opioid overdose. Production of alternatives to injectable naloxone is seen as an important strategy for widening access to the overdose reversal drug and for easing concerns about the drug's cost.

A statement from Lightlake says that the nasal spray “should be administered as quickly as possible if a patient is unresponsive and an opioid overdose is suspected, even when in doubt.”

The nasal-spray formulation is expected to become available in early 2016.