Emergent Bio Solutions received FDA approval today to market an over the counter (OTC) 4mg nasal spray to reverse opioid overdose. What does that mean to the public and the industry?
For the public, as soon as the company begins distributing the product, it means easy access to a potentially lifesaving emergency medication to treat opioid overdose. The Agency notes in its new release (here) that “[T]he timeline for availability and price of this OTC product is determined by the manufacturer” indicating that it may be a while to see the product in stores “like drug stores, convenience stores, grocery stores and gas stations as well as online”.
The fact that FDA approved an OTC version of naloxone for opioid overdose means that all existing products approved for this use that relied on Narcan as the reference listed drug (RLD) for their ANDAs will need to supplement their approved applications for the 4mg product with new labeling, as once an indication switches from Rx to OTC for all approved uses, there can be no Rx products without a prescription leave behind prescription indication. The Agency also said “[T]he approval may also affect the status of other brand-name naloxone nasal spray products of 4 mg or less, but determinations will be made on a case-by-case basis and the FDA may contact other firms as needed”.
FDA says it will work with manufacturers to assure the availability of the product as the transition to OTC status, the Agency says could take months, and during the transition other 4mg/spray products will still be available by prescription. There are currently three (3) other manufacturers of a 4mg/spray prescription naloxone product. Pending applications that rely on Narcan as the RLD(if any) for naloxone 4mg/spray will also need to amend their applications to revise labeling to make the OTC switch.
The news release also stated that “in accordance with a process to change the status of a drug from prescription to nonprescription, the manufacturer provided data demonstrating that the drug is safe and effective for use as directed in its proposed labeling. The manufacturer also showed that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional’ which is typical for an Rx to OTC switch. There is an 8mg/spray product approved that will at this time remain Rx only.
The FDA advisory committee unanimously recommended that all 4mg/spray and lower strengths be OTC and the FDA took the committee’s recommendation. Now the job is left up to the manufacturers and application holders to do the work necessary to get their products to the OTC marketplace.