2023 IS the Year for OTC Naloxone!

Early on March 29, 2023, FDA announced the landmark approval of Narcan (naloxone hydrochloride) Nasal Spray for use as a nonprescription opioid overdose reversal agent.  I previously blogged on the February 15, 2023 Joint Meeting of the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) which unanimously agreed that the benefit-risk profile of Narcan Nasal Spray (NNS) is “supportive of its use as a nonprescription opioid overdose reversal agent.”  FDA Commissioner Robert M. Califf, M.D. announced that “Today’s approval of OTC naloxone nasal spray will help improve access to naloxone, increase the number of locations where it’s available and help reduce opioid overdose deaths throughout the country.”  Both harm reduction experts and FDA have long agreed that the prescription status for naloxone posed a barrier to wider access to this safe and life-saving drug.  While many states have had standing orders that allow for the dispensing of naloxone without an individual prescription, “harm reduction programs” that provide products and services to at-risk individuals still faced logistical difficulties in acquiring naloxone due to its prescription-only status which I discussed in this October 2022 blog post.

Now what?

When OTC NNS will become commercially available is ultimately determined by the sponsor of the drug—Emergent BioSolutions.  Emergent will need time to manufacture and distribute NNS with the new OTC labeling, so the public should not expect to be able to walk into their local pharmacy and grab a box off the shelf in the coming days.

NNS (N208411) is the reference listed drug (RLD) which applicants have relied on for approval of generic versions of naloxone nasal spray.  The sponsors of the currently approved 4 mg generic naloxone nasal spray products that rely on Narcan as the RLD will need to submit supplements to their applications (A209522, A211951) to also switch their drugs to OTC status.  However, additional naloxone products will remain prescription drugs.  The OTC approval of NNS will not change the prescription status of the 21 injectable naloxone products listed in the Orange Book.  Additionally, 8 mg naloxone nasal spray (N212045) is also still a prescription drug.

Today’s OTC naloxone approval is limited to NNS specifically, but we are aware of other OTC naloxone applications currently being reviewed by FDA.  I previously blogged on the cancellation of the Joint Meeting scheduled on March 20 to discuss the direct-to-OTC application for 3 mg naloxone nasal spray submitted by Harm Reduction Therapeutics under the trade name RiVive.  Last week Harm Reduction Therapeutics announced that it has entered into a commercial supply agreement with Catalent which will manufacture RiVive—if approved—at its facility in Morrisville, North Carolina.  According to this announcement, FDA approval of RiVive is anticipated in July 2023 and the U.S. launch would be in early 2024.

How “accessible” will OTC naloxone really be?

In announcing the approval, Commissioner Califf encouraged the manufacturer to make OTC NNS available “at an affordable price,” but FDA does not ultimately have control over Emergent’s pricing.  Prescription naloxone has generally been covered by private health insurance, Medicaid, and Medicare Part D meaning that it has been available to many people for free or at a low price through their insurers.  However, many insurance plans do not cover OTC drugs so there are concerns that the out-of-pocket price for OTC NNS could potentially increase for those accessing the drug through their health insurance.  In addition to price, physical barriers such as placing NNS in a locked box or behind-the-counter in the pharmacy would also impede accessibility.  While accessibility is an open and important question, approval of OTC NNS is nevertheless a crucial and life-saving step in combatting the ongoing opioid crisis.