An FDA advisory committee voted Thursday to remove compounding restrictions on two peptides -- BPC-157 and KPV -- despite little evidence the products are safe or effective for medical use.
BPC-157, touted by wellness influencers and considered a doping substance by international sports authorities, is being proposed as a treatment for ulcerative colitis. KPV, meanwhile, is being proposed for inflammatory conditions and wound healing.
In a series of 8-6 votes (with one abstention), the panelists recommended that the free base and acetate forms of the peptides be placed on the agency's 503A bulk drugs compounding list, which allows pharmacies to make compounded versions.
The votes came on the first of a 2-day meeting of the agency's Pharmacy Compounding Advisory Committee, where more than half a dozen peptides are under review for conditions that also include obesity, osteoporosis, opioid withdrawal, insomnia, narcolepsy, cerebral ischemia, migraine, and trigeminal neuralgia.
FDA staff has recommended against putting any of the peptides on the compounding list, noting that their chemical makeup "was not well characterized" and that few safety or efficacy studies support them for the proposed uses.
