FDA Advisory Panel Recommends Compounding Epitalon And Semax, Rejects Emideltide

An FDA advisory panel voted to recommend allowing compounding pharmacies to manufacture the peptides epitalon and semax, while narrowly voting to recommend against manufacturing emideltide, as the two-day meeting continued after Thursday’s vote on four other peptides.

“recommended on Friday that compounding pharmacies be allowed to manufacture the peptides epitalon and semax”

STAT

The panel’s Thursday recommendations covered adding BPC-157, KPV, and TB-500 to the “503A Bulks List,” and adding MOTS-c for obesity and osteoporosis, with the vote on BPC-157, KPV, and TB-500 reported as 8-6 and the vote on MOTS-c reported as 7-5.

Ars Technica

On Friday, the panel voted 7-4 to add epitalon for insomnia and voted 8-5 to add semax for migraines as well as cerebral ischemia and trigeminal neuralgia.

The same Friday vote failed for emideltide, with a tally of 6-7, as the peptide was under consideration for opioid withdrawal, chronic insomnia, and narcolepsy.

The FDA does not have to follow the panel’s advice, and FDA staff told panelists they recommended against giving compounders the green light due to a lack of clinical evidence demonstrating safety and efficacy.

FDA staff warned that adding peptides to the 503A bulk drug substances list would be a dangerous experiment, with physicians flying blind as far as dosing data and best prescription practices, and Mary Thanh Hai said, “In the grey market, that’s not a requirement to be sent to us.”

Panelists who voted yes said they were not voting to approve a drug and did not have to consider the lack of robust clinical data, and Asare Christian, founder of wellness clinic Aether Medicine, said, “As a physician, my view is through the lens of the patient in front of me.”

Ars Technica

David Pope, the chief pharmacy officer at XiFin Pharmacy Solution, joined the dissenters after voting with the majority for the previous peptides and said he was concerned about emideltide’s “potentially dangerous downstream consequences.”

BioPharma Dive described the meeting as a collision between career FDA scientists and supporters of the “MAHA” agenda, noting that the panel’s votes were close and that advisers recommended lifting restrictions that stop specialized compounding pharmacies from making certain peptides.B

NPR reported that the panel recommended reclassifying almost all of the compounds under consideration, and it said the FDA committee was tasked with reviewing data for seven different peptide therapies, none of which are FDA-approved drugs.N

The administration will publish its decision as a proposed rule and give the public the opportunity to comment, after the advisory panel’s recommendations brought Health Secretary Robert F. Kennedy Jr. “one step closer to his mission of making these unapproved compounds more available for Americans.”

“The administration will publish its decision as a proposed rule and give the public the opportunity to comment”

STAT

STAT reported that FDA experts repeatedly stressed that adding the peptides to the section 503A bulk drug substances list would be a dangerous experiment, and it said the agency has no authority to require compounders to submit safety or efficacy data once a substance is added to the list.

NPR said that if the FDA takes the panel’s recommendations, clinicians could have the ability to prescribe six peptide therapies: BPC-157, MOTS-c, KPV, TB-500, Epitalon and Semax, while emideltide was the only one to receive a down vote.N

Fierce Pharma reported that the FDA is not required to follow the recommendations of the Pharmacy Compounding Advisory Committee, and it said the agency will make the final decision on whether the peptides can be manufactured by compounders.

Ars Technica framed the outcome as a committee organized by the FDA voting to endorse removing restrictions on the manufacture of peptides for human use, with votes on four peptides recommended for lifting limits and votes on three additional peptides scheduled for today.