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# Petition Questions Intranasal Naloxone Efficacy
- URL: https://www.fdaweb.com/petition-questions-intranasal-naloxone-efficacy/
- Published: 2017-01-24T12:00:00.000Z
- Updated: 2026-09-14T22:02:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137808

Mucodel Pharma, which is developing a buccal naloxone product, has asked FDA not to approve any intranasal (IN) naloxone NDA or ANDA for the emergency treatment of a known or suspected opioid overdose until the agency considers whether such an application adequately addresses the reliability of IN naloxone in actual field use. The company [petition](lhttp://webmail.fdaweb.com/a/webmail.php?wsid=312b5a71fb341462c0322e3f9ffbe79cc8057ac5) says such a requirement is critical to ensure the public health and thus FDA should address the petition before approving a new IN naloxone product.

According to Mucodel, Narcan, the IN naloxone reference-listed drug, was approved on the basis of fast-track designation and priority review, due to the pervasive opioid crisis, needle-stick risk associated with intramuscular delivery, and the desire to have an approved IN alternative to unapproved IN naloxone kits.

“Petitioner contends that reliability of delivery is particularly important where a drug is administered by non-medically trained personnel, including police and family members,” the petition says. “Petitioner believes that legitimate questions exist concerning the reliability in field use of IN naloxone, and that FDA should therefore consider whether new IN applications adequately address the potential efficacy disparity of IN naloxone versus IM naloxone in actual field use.”