On the second day of a two-day advisory meeting, FDA outside experts delivered their first rejection of the week, voting down emideltide for the 503A Bulk Drug Substances list.
The FDA’s Pharmacy Compounding Advisory Committee voted seven to six against recommending both emideltide free base and emideltide acetate, with one panelist abstaining from both votes.
The peptide had been under consideration as a potential compounded treatment for opioid withdrawal, chronic insomnia, and narcolepsy.
In its briefing package, the FDA said emideltide is not adequately characterised and carries the potential for peptide-related impurities due to incomplete coupling reactions, truncations, or side reactions.
The agency also noted that FDA-approved therapies already exist for insomnia, narcolepsy, and opioid withdrawal, weakening the case for adding emideltide to the bulk compounding list.
FDA’s Katie Park stated that “there is a lack of safety and efficacy data to support using emideltide for treating insomnia, narcolepsy and opioid use disorder.”
David Pope, the chief pharmacy officer at XiFin Pharmacy Solution, voted against inclusion, saying he was concerned about emideltide’s “potentially dangerous downstream consequences.”
Not all panelists agreed with the outcome, with Tennessee state Senator Bobby Harshbarger arguing he voted yes “because our duty is to apply the 503A standards, not the Investigational New Drug Application standard.”
Gabriel Alizaidy, M.D., of Maximus Health, also voted in favour, contending there was a “mismatch in real-world data” on the peptide’s use versus what the FDA had presented, calling the disparity “immense.”
By contrast, epitalon and semax fared considerably better on Friday, with the panel recommending both peptides be permitted for manufacture by compounding pharmacies.
Those approvals followed Thursday’s decisions to recommend allowing pharmacies to compound four other peptides: BPC-157, KPV, TB-500, and MOTS-c.
The two-day meeting, held on 23 and 24 July, placed seven peptides before the committee in total, drawing intense public interest from patients, physicians, and compounding industry representatives.
Thursday’s session stretched for nearly 12 hours and included near-unanimous public comment urging that access to the peptides be restored, while FDA scientists raised concerns over safety and a lack of clinical evidence.
The outcomes bring health secretary Robert F. Kennedy Jr. closer to his stated goal of making these unapproved compounds more widely available to Americans seeking access to them.
The FDA is not bound by the committee’s recommendations, and any formal change to the bulk substances list would require a rulemaking process estimated to take between eight and twelve months.
The two-day meeting underscored broader tensions between the Make America Healthy Again movement and mainstream scientists over whether individuals should be permitted to use medicines of unclear safety or efficacy.