Home / Health / FDA Panel Backs Unproven Peptide Access
FDA Panel Backs Unproven Peptide Access
27 Jul
Summary
- An FDA panel recommended allowing compounding pharmacies to make two more unproven peptides.
- Epitalon and semax were recommended for easier access, while emideltide was rejected.
- Most reviewed peptides are injected and lack full FDA approval or extensive clinical data.
A federal advisory panel has recommended that the U.S. Food and Drug Administration (FDA) allow compounding pharmacies to prepare two more unproven peptides, epitalon and semax. The panel voted on Friday to add these substances to a list that permits specialized pharmacies to create them for patients without further agency review. This marks the first instance of an FDA panel voting to ease access to such compounds.
In addition to epitalon and semax, the committee had previously recommended four other peptides: BPC-157, KPV, MOTS-c, and TB-500. However, a third compound, emideltide, which is naturally produced in the brain and affects the opioid pathway, was narrowly rejected due to concerns about potential addiction and dangerous downstream consequences.
Despite the panel's recommendations, FDA scientists had cautioned against the compounds, citing a lack of clinical evidence for their safety and effectiveness. Some panelists, particularly those associated with clinics that offer peptides, voted in favor based on patient demand rather than formal approval standards. The FDA will publish its final decision as a proposed rule, followed by a public comment period.
