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.
The company’s distribution operation includes a warehouse in Lakeland, where DataMEDS intends to handle supplies from manufacturers and make the ingredients available to qualifying compounding pharmacies through its existing third-party logistics business. Its network of more than 6,500 independent pharmacies provides a potential customer base, although the announcement does not establish how many will purchase the ingredients or offer the prescriptions. DataMEDS also plans to use its Health Lives Here mobile application to collect and report safety information under the new federal policy.
The FDA’s Pharmacy Compounding Advisory Committee considered the six substances during meetings July 23 and 24, examining proposed uses ranging from wound healing and inflammatory conditions to obesity, insomnia and neurological disorders. Those applications remain unproven, and the HHS enforcement policy does not grant FDA approval. Participating pharmacies must meet requirements involving ingredient sourcing and testing, patient-specific prescriptions, labeling and reporting of adverse events and product-quality problems, while federal officials retain the ability to change or withdraw the policy.
DataMEDS has not disclosed the financial terms of its supply agreement, the identity of its supplier or how much revenue it expects the arrangement to generate. Its planned November rollout will run through Corexa Pharmacy, part of a healthcare operation that also includes pharmaceutical distribution, technology platforms and a clinical diagnostics laboratory in Pittsburgh.