A higher dose naloxone hydrochloride nasal spray (8 mg) for the treatment of opioid overdose has now been sanctioned by the FDA, as announced on April 30, 2021.This nasal spray has already been approved in 2 and 4 mg dosages (in the year 2015).

This opioid-receptor antagonist can be administered with or without medical training can help decrease the deaths due to opioid overdose. A rapid use of this nasal spray can neutralize the opioid overdose effects, typically in minutes.

 “Focusing on the opioid crisis is of utmost importance to the FDA, and efforts to escalate access to naloxone and place this medicine in the needful can help tackle opioid overdose,” mentioned the M.D. of the FDA’s Center for Drug Evaluation and Research (CDER).

After the approval of naloxone in 1971 for the treatment of opioid overdose, FDA has taken a numerous steps to improve accessibility of naloxone products, i.e: encouraging the companies to follow authorization of over-the-counter naloxone products; requiring pharmaceuticals for all opioid analgesics to add naloxone’s latest recommendations to the prescribing information; and prolonging its shelf life from 2 years to 3 years.

Application of naloxone in opioid-dependent patients may lead to opioid withdrawal depicted by body pains, diarrhea, tachycardia, runny nose, fever, sneezing, piloerection, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal pain, weakness and high BP.