FDA Approves Increased Dosage of Naloxone Nasal Spray for Opioid Overdose

The US Food and Drug Administration (FDA) has approved naloxone hydrochloride nasal spray at 8 mg to treat opioid overdose. The nasal spray had previously been approved at 2 mg and 4 mg.

Naloxone is delivered into the naval cavity and can be administered by individuals with or without medical training. Immediate use of the spray following overdose can counter the effects and thus reduce related deaths.

"Today's action meets another critical need in combatting opioid overdose," said Patrizia Cavazzoni, MD, director of the FDA's Center for Drug Evaluation and Research in a statement. "Addressing the opioid crisis is a top priority for the FDA, and we will continue our efforts to increase access to naloxone and place this important medicine in the hands of those who need it most."

Potential effects associated with naloxone use are characteristic of opioid withdrawal, such as body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.

This approval comes in the wake of the FDA’s attempts to improve availability of and access to naloxone produce.

Steps the agency has taken include encouraging manufacturers to submit for over-the-counter product approvals, requiring that drug manufacturers add recommendations about naloxone to the prescribing information on all opioid pain relievers and medicines, and extending the shelf life of naloxone nasal spray from 24 months to 36 months.