FDA approves Narcan Nasal Spray to treat opioid overdose

The US Food and Drug Administration (FDA) has approved Adapt Pharma’s Narcan (naloxone hydrochloride) Nasal Spray for the emergency treatment of known or suspected opioid overdose.

Until this approval, naloxone was only approved in injectable forms, most commonly delivered by syringe or auto-injector. Many first responders and primary caregivers, however, feel a nasal spray formulation of naloxone is easier to deliver, and eliminates the risk of a contaminated needle stick. As a result, there has been widespread use of unapproved naloxone kits that combine an injectable formulation of naloxone with an atomizer that can deliver naloxone nasally. Now, people have access to an FDA-approved product for which the drug and its delivery device have met the FDA’s high standards for safety, efficacy and quality.

Narcan Nasal Spray is a needle-free device that delivers a 4 mg dose of naloxone in a single 0.1 ml nasal spray. Narcan Nasal Spray can be administered in an emergency by family members, caregivers or others to reverse the effects of opioid overdose until help arrives. An opioid overdose may cause brain damage or death, so Narcan Nasal Spray should be administered as quickly as possible if a patient is unresponsive and an opioid overdose is suspected, even when in doubt.

“We heard the public call for this new route of administration, and we are happy to have been able to move so quickly on a product we are confident will deliver consistently adequate levels of the medication – a critical attribute for this emergency life-saving drug,” said Janet Woodcock, M.D., director of the FDA’s Centre for Drug Evaluation and Research.

Narcan Nasal Spray offers an alternative treatment option to injectable formulations

In the US, opioid overdose related deaths are growing and claimed almost 24,500 lives in 2013, or an average of one life every 21 minutes. The majority of those deaths involved prescription opioids and happened in people’s homes.

 “Opioid overdose is responsible for the deaths of thousands of Americans in communities throughout the country, leaving a trail of devastation for friends and families,” said Seamus Mulligan, Chairman and CEO of Adapt Pharma. “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. It gives new hope to those concerned about the potentially fatal effects of opioid overdose.”