OPDP slams cholesterol drug's e-mail claims

OPDP slams cholesterol drug's e-mail claims
OPDP slams cholesterol drug's e-mail claims

Drug companies may want to conduct head-to-head clinical trials before they make superiority claims, Cipher Pharmaceuticals has learned. The Office of Prescription Drug Promotion (OPDP) issued the drugmaker an Untitled Letter on September 11 following an e-mail alert the company distributed touting “unsubstantiated claims,” in the agency's words, for its triglyceride- and cholesterol-lowering treatment Lipofen.

The e-mail sent to healthcare professionals began with the subject line, “All fenofibrates are not created equal,” and goes on to state that “other fenofibrates are formulated with small particles, which may affect absorption,” while with Lipofen, “particle size is not an issue.” Lipofen is produced by Cipher, but marketed by Kowa Pharmaceuticals.

The drugmaker continued to tout its delivery system, claiming, “Fenofibrate is in an already-dissolved state, making it readily available for absorption,” as well as, “Lipofen with Lidose technology offers a very homogeneous distribution of fenofribate in the mass of excipients.”

The “e-Pharma/alert” went on to use language one would expect more from a bodega counter fat burner than a cholesterol-lowering prescription—stating that Lipofen “uses a unique melt matrix system” and is “not available with any other generic or brand-name fenofibrate.”

OPDP concluded that the overarching message Cipher made through these claims “implies that Lipofen offers a clinical advantage over other available fenofibrate products, as a result of its formulation and delivery system, when this has not been demonstrated by substantial evidence,” and went on to say that nothing the drugmaker referenced contained “any clinical trial data comparing Lipofen to other fenofibrate products to support claims of superiority… FDA is not aware of any head-to-head clinical trials comparing appropriate doses and dose regimens of your drugs and the comparator drugs.”