Naloxone is one of the safest drugs in the U.S. Pharmacopeial Convention, with minimal toxicity, and it is not a controlled substance, Dr. Coffin noted. It is available in a vial for injection, as an intranasal formulation given off-label, and as an autoinjector specifically designed for lay administration that was recently approved by the U.S. Food and Drug Administration. Two intranasal formulations are being developed.
Randomized, feasibility, and qualitative studies of the naloxone approach are underway. Obtaining data on the impact of take-home naloxone on events such as opioid analgesic overdoses and behavioral effects is a critical research need, Dr. Coffin said.
Dr. Coffin had no disclosures. The NOSE study is being funded by the National Institute on Drug Abuse (NIDA). The workshop was sponsored by the National Institutes of Health (NIH) Office of Disease Prevention, the NIH Pain Consortium, NIDA, and the National Institute of Neurological Disorders and Stroke.