FDA approves higher dosage of naloxone nasal spray

On April 30, FDA announced the approval of a higher dosage of naloxone hydrochloride nasal spray (Kloxxado—Hikma Pharmaceuticals) to treat opioid overdose. The newly approved product delivers 8 mg of naloxone into the nasal cavity, compared with previously approved 2- and 4-mg naloxone nasal spray products.

FDA has taken several steps in recent years to increase the availability of naloxone products, including encouraging manufacturers to pursue approval of OTC naloxone products, requiring manufacturers for all opioid analgesics and medicines to treat opioid use disorder to add new recommendations about naloxone to the prescribing information, and extending the shelf life of naloxone nasal spray to 36 months from 24 months.

The use of naloxone in patients who are opioid-dependent may result in opioid withdrawal characterized by 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.

FDA granted approval of the higher dose product after Hikma submitted a 505(b)(2) application that relied, in part, on FDA’s finding of safety and effectiveness for naloxone hydrochloride (Narcan injection) to support approval. The applicant demonstrated that reliance on 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.