FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose

The FDA is committed to using its regulatory authority to address the opioid crisis with a focus on: decreasing exposure to opioids and preventing new addiction; fostering the development of novel pain treatment therapies; supporting treatment of those with opioid use disorder; and improving enforcement and assessing benefit-risk.

The use of naloxone in patients who are opioid-dependent may result in opioid withdrawal characterized by body aches, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps (piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness and increased blood pressure.

The FDA granted approval of KLOXXADO to Hikma Pharmaceuticals through the 505(b)(2) approval pathway under the Federal Food, Drug, and Cosmetic Act. A new drug application submitted through this pathway may rely on the FDA's finding that a previously approved drug is safe and effective or on published literature to support the safety and/or effectiveness of the proposed product, if such reliance is scientifically justified. In this case, the manufacturer submitted a 505(b)(2) application that relied, in part, on the FDA's finding of safety and effectiveness for naloxone hydrochloride (NARCAN injection) to support approval. The applicant demonstrated that reliance on the FDA's finding of safety and effectiveness for Narcan was scientifically justified and provided KLOXXADO-specific pharmacokinetic data to establish the drug's safety and efficacy for its approved use.