Two major pharmaceutical manufacturers have been approved by the United States Food and Drug Administration (FDA) to market new strengths of their naloxone products. Narcan® Nasal Spray and Evzio® auto-injector are indicated for the emergency treatment of opioid overdose, as manifested by respiratory and/or central nervous system depression. These formulations are designed to be administered to a patient with known or suspected opioid overdoses by a family member or caregiver.
One year after its original FDA approval, Adapt Pharma’s Narcan Nasal Spray, the needle-free, intranasal formulation of naloxone, will now launch a 2 mg dose, as it was previously only available in a 4 mg dose. It has not been announced when this new strength will be available.
At the end of 2016, kaleo® Inc. released a new 2 mg dose of Evzio (naloxone injection) auto-injector. Previously, Evzio auto-injector was only available in 0.4 mg dose. The manufacturer reported they were the first to offer a 2 mg take-home naloxone injection to be administered during an opioid emergency, which is currently available in the marketplace. According to their website, however, their 0.4 mg dose will no longer be manufactured, although the date production will cease was not reported. However, if a claimant has been prescribed the 0.4 mg auto-injectors, the manufacturer has advised this strength remains safe and effective for treatment of an opioid emergency and can be used until its expiration date. As a reminder to all healthcare professionals and claims adjusters, these take-home naloxone products are not a substitute for emergency medical care.
2. Evzio® (naloxone HCl) auto-injector. kaleo, Inc. website. Available at https://www.evzio.com/hcp/. Accessed Jan 26, 2017.
1. Narcan® (naloxone HCI) Nasal Spray 2 mg Approved by US Food and Drug Administration (FDA) [news release]. Dublin. Adapt Pharma’s website. Available at http://adaptpharma.com/adapt_press_release/january-25-2017-narcan-nasal-spray-2mg-approved-by-us-food-and-drug-administration/. Accessed Jan 26, 2017.