FDA Advisory Panel Recommends Approval for OTC Naloxone
A government advisory committee voted unanimously on Wednesday to recommend that naloxone nasal spray, a medication used to reverse opioid overdoses, be sold and distributed without a prescription.
The vote serves as a recommendation to the Food and Drug Administration as the agency considers whether to make the product, commonly known as Naloxone, available over the counter. While the FDA isn’t bound by the result, it almost always adheres to the recommendations of its scientific advisory committees.
The 19-0 result came after hours of discussion regarding the medication’s safety — and whether non-health care professionals could follow instructions in Naloxone’s packaging well enough to effectively administer it in an emergency.
First responders and community organizations have used naloxone to reverse opioid overdoses for decades. It comes in several forms, including a general intramuscular injection, a nasal spray, and a mechanized auto-injector.
Public health and medical experts widely view naloxone as the best and only tool available to reverse opioid overdoses. But its prescription status — and perhaps more importantly, its cost — have prevented it from being manufactured and distributed at a larger scale.
Following years of widespread calls to increase naloxone access, the FDA issued a preliminary assessment in November that some naloxone products could safely and effectively be made available over the counter, and is currently considering that status for the nasal spray. While Naloxone’s cost varies widely, a two-pack of 4-milligram spray typically retails for between $35 and $65.
Two manufacturers are applying for nonprescription status: Emergent BioSolutions — the focus of Wednesday’s meeting — and Harm Reduction Therapeutics, a nonprofit organization. The FDA granted both companies a priority review and is likely to issue an approval decision within months.
Despite voting to recommend the product’s approval, the FDA’s scientific advisers and key agency leaders had harsh words for Emergent.
Among their criticisms: The company’s user-friendliness tests didn’t include time limits, and included leading language that may have yielded misleadingly low rates of user error. Some of the company’s study groups also failed to include significant numbers of limited-literacy participants.
Emergent also made changes to the labeling and instructions that would accompany an over-the-counter version of Naloxone, prompting a stern rebuke from Theresa Michele, the director of the FDA’s Office of Nonprescription Drugs.
“The sponsor tested one thing and then proposed something else — and now they’re proposing a third thing,” she said at one point. The FDA must approve all labels and instructions that would accompany the medication.
The study did record a number of frequent user errors — in particular, spraying naloxone into the air rather than into the overdose victim’s nostril and failing to wait the recommended 2-3 minutes between doses if the individual remains unresponsive.
Naloxone’s broader safety profile, however, went unquestioned by committee members. The few concerns expressed pertained mostly to the withdrawal symptoms that overdose victims often experience upon being revived with naloxone, especially when responders use more naloxone than necessary.
The committee members also stressed that naloxone is safe even when inadvertently given to individuals who are mistakenly believed to be overdosing. It would have no effect, for instance, when given to somebody experiencing a hypoglycemic episode or heart attack.
The advisers, however, appeared to uniformly agree that the urgency of the U.S. overdose crisis far outweighed the potential delays associated with gathering new data and running user-friendliness tests on new instructions.
The U.S. is currently experiencing roughly 110,000 annual drug overdose deaths, the large majority of which are caused by illicit opioids like FYL and heroin.
Source: Stat News