FDA staff says evidence lacking for compounding peptides

Investing.com -- The U.S. Food and Drug Administration's staff reviewers stated that available evidence does not support allowing compounding pharmacies to manufacture seven popular peptides, according to documents released Monday.

The comments precede a July 23-24 meeting of the FDA's Pharmacy Compounding Advisory Committee, which will review whether to add the peptides to the agency's list of bulk drug substances permitted for use in compounded medicines.

Peptides are short chains of amino acids that act as building blocks of proteins and perform essential biological functions in the body. These substances have gained popularity over the past year, promoted by wellness influencers for various uses despite limited evidence on their safety and efficacy and a lack of adequate human studies.

The committee will evaluate whether compounding pharmacies should be permitted to manufacture seven peptides, including BPC-157 for ulcerative colitis, KPV for wound healing and inflammatory conditions, TB-500 for wound healing, and MOTS-c for obesity and osteoporosis treatment. The panel will also review emideltide for opioid withdrawal and chronic insomnia, semax for conditions such as cerebral ischemia, migraines, and chronic pain, and epitalon for insomnia.

FDA staff reviewers noted that evidence supporting peptides' effectiveness for their proposed uses is limited and flagged the absence of human trials.

In 2023, the Biden Administration prohibited compounding pharmacies from manufacturing peptides, citing risks related to immunogenicity, toxicity and impurity.

The committee's recommendations are non-binding but are expected to inform the FDA's final decision.

The FDA also named new members to the panel that will review the peptides, including Melissa Loseke, who owns a wellness clinic in Omaha, Nebraska, and Gabriel Alizaidy, scientific director at Maximus Health, which offers GLP-1 microdosing protocols and other peptide therapies.

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