An FDA director responded to criticism over the agency’s approval process of the nasal spray naloxone (Narcan), an opioid overdose reversal agent intended to be administered by EMS personnel.

Sharon Hertz, MD, director of the Division of Anesthesia, Analgesia, and Addiction Products at the FDA’s Center for Drug Evaluation and Research (CDER), rebutted Medpage Today article that suggested the drug was unproven and that its approved dosage may be problematic.

From the original Medpage Today article…

“…Several experts contacted by MedPage Today on the day [Narcan] was approved noted that they were eager for real-world results, because only pharmacokinetic and usability data were needed for FDA approval. [The drug’s manufacturer] didn’t have to conduct any field trials.

“Because it was approved with no field testing to get it approved quickly, we don’t know how it works in the real world,” said Caleb Banta-Green, PhD, MPH, of the University of Washington.

Within a few weeks, researchers started raising questions about the dose of the new nasal formulation: 4 mg. The off-label nasal naloxone was given at a dose of 1 mg, and the injectable at 0.4 mg.”

In response, the FDA’s Hertz defended the agency’s approval process of Narcan and allayed concerns over dosage.

“As we do for all new drug products, the FDA carefully weighed the risks and benefits of Narcan, the first FDA-approved nasal spray form of naloxone. Naloxone products in other dosage forms have been approved and on the market for decades, and the mechanism of action and side effects of naloxone are well understood.

Accordingly, the sponsor of Narcan demonstrated that the product was safe and effective primarily by showing that it delivered appropriate amounts of the drug into a patient’s bloodstream. Additional studies were not needed in order to meet FDA’s requirements to approve this formulation.”

Hertz wrote that the drug can play a role in efforts to reduce opioid-related overdoses and deaths and the agency will continue to monitor the drug’s safety once it is on the market.