Drug News

Abstract

The FDA has approved a nasal spray formulation of naloxone hydrochloride for widespread use. Naloxone nasal spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression; the drug usually takes effect within 2 minutes. The drug’s rapid 4-month approval is part of the FDA’s commitment to expedite new medications that show promise in the fight against the nation’s rising drug abuse epidemic. Previously, the medication was approved in injectable form, but many first responders and clinicians find that a nasal spray is more accessible and easier to administer. The spray doesn’t require assembly; the formulation delivers a measured dose into one nostril while the patient is supine. If the patient doesn’t respond or responds and then relapses into respiratory depression, the clinician administers additional doses every 2 to 3 minutes until emergency medical assistance arrives. In trials, the spray delivered the same levels of naloxone in the same time frame as an I.M. injection. Further medical attention should be sought immediately after the patient receives the dose. Adverse reactions among opioid-dependent patients include withdrawal symptoms such as nausea, tachycardia, and hypertension.