Tampa-based DataMEDS AI has struck a supply deal for six experimental peptides that have never received FDA approval, moving into a controversial corner of the prescription drug market just days after federal health officials announced a policy change affecting how the substances can be compounded and dispensed. The Nasdaq-listed healthcare company announced Monday that its subsidiary, Corexa Health, plans to begin filling prescriptions this month, with access to a network of more than 6,500 independent pharmacies.
The agreement follows an Oct. 30 policy change by the U.S. Department of Health and Human Services, which established a limited path for licensed pharmacies to compound certain peptides while the Food and Drug Administration continues reviewing whether the substances belong on its list of permitted ingredients. Peptides are short chains of amino acids, the building blocks of proteins, and some have attracted interest as potential treatments for inflammation, tissue damage, obesity and neurological conditions. The six covered by the agreement — BPC-157, TB-500, KPV, MOTS-c, Epitalon and Semax — have not been evaluated by the FDA for safety or effectiveness.
DataMEDS, formerly known as Wellgistics Health, is entering a market where consumers have been purchasing experimental peptides online under research-use-only labels, often outside the safeguards associated with licensed pharmacies. Gerald Commissiong, the company’s interim co-CEO, wants to bring some of those customers into conventional prescription channels, where physicians can prescribe compounded preparations and pharmacists can dispense them under applicable federal and state requirements. “We believe that many gray market patients would prefer to purchase their peptides from a licensed pharmacy,” Commissiong said…