“An official formulation of nasal naloxone for reversing opioid overdoses that doesn’t have to be used off-label may be on the market soon.
Lightlake Therapeutics has opened a rolling submission of the NDA for its nasal naloxone to the FDA, according to a release from the National Institute on Drug Abuse (NIDA), which is partnering with the company to develop the drug.
Naloxone is technically only available as an injection, made by Hospira, and in auto-injector form known as Evzio by Kaleo Pharma. Amphastar sells the lone nasal formulation — the concentration of the drug is higher than that of injectable naloxone since it’s not administered into or near the blood stream — but it is technically for off-label use.”
Source: MedPageToday.com – June 13, 2015