A lifesaving treatment to reverse opioid overdoses has just been shifted from Rx to OTC, making it available without a prescription throughout the US. The medication, Naloxone, is a competitive inhibitor of the mu-opioid receptor. This means that it antagonizes the actions of opioids, reversing their effects. It rapidly reverses an opioid overdose but will have no effect if the patient has not taken any opioids. According to the National Institute on Drug Abuse, there were over 80,000 deaths involving overdoses on opioids in 2021. In much of the country, insurance companies, governments, and non-profit organizations subsidize Naloxone distribution. A large-scale national study published in the peer-review journal Addictive Behaviors showed that states that enacted Naloxone access laws decreased opioid overdose deaths by 14%.
On February 15th, 2023, a joint meeting was held with the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). They voted unanimously to make the nasal-spray version of Narcan available without a prescription. The meeting discussed the adequacy of data presented in the supplemental new drug application submitted by Emergent Biosolutions Inc. for a nonprescription application.
On March 29th, 2023, the FDA approved Narcan, 4mg naloxone hydrochloride nasal spray for OTC, nonprescription use to Emergent Biosolutions Inc. The expected over-the-counter availability is anticipated to be the late summer of this year. Some states already had special processes to provide specific naloxone products to patients without a physician’s prescription, but this change makes the drug available nationwide without a prescription.
While this approval is a substantial public health win, there is always the barrier of patient costs. In a study published in the JAMA Health Forum in August 2022, the mean out-of-pocket costs for insured patients was $28.46, and uninsured patients paid an average of $6.93 more. Current WAC pricing for a two-pack of Narcan costs around $125; it is unclear whether Emergent Biosolutions Inc. will continue to sell the drug at that cost. No current information on how much OTC Narcan will cost when it becomes available. What impacts do you expect from this announcement?
Posted: March 2023