Discovery Laboratories was warned by the regulator after a review of its website revealed that the company made unsupported superiority claims about Surfaxin as well as claims indicating that the RDS-prevention drug is intended for a use for which it lacks approval and for which its labeling fails to bear adequate direction.
The letter states that the home page of the company’s website for Surfaxin is false or misleading because it makes superiority claims that weren’t proven by substantial evidence or clinical experience. Consequently, the webpage misbrands the product, approved for the prevention of respiratory distress syndrome (RDS), and renders its distribution “violative,” the OPDA wrote.
According to the letter, the claims “Surfaxin, the only available synthetic alternative to animal-derived surfactants approved by the FDA” and “Join the Therapeutic Evolution … ,” which are presented alongside graphics of a pig, a cow and a humanlike robot, misleadingly imply that the drug is superior to animal-derived surfactants like Curosurf and Survanta. The FDA wrote that there doesn’t appear to be any substantial evidence to support Surfaxin’s claim of superiority to these, nor are there any references cited to back up the claims. The letter also cites a lack of evidence or cited references to back up a number of other claims, including that one of Surfaxin’s ingredients works as a “mimic” of endogenous human SP-B.
The letter also targets the claim “Direct clinical comparisons to Exosurf, Exosurf and Curosurf,” which the webpage supports by citing two publications describing clinical studies used for Surfaxin’s approval. The OPDP wrote that the studies don’t constitute substantial evidence to support a direct clinical comparison claim because they either measured the efficacy of the drug only in comparison to another synthetic surfactant or only supported the safety of the drug. Another study cited by Discovery to support superiority claims was also targeted by the agency, which said that because the survey described in the study didn’t include measures specifically assessing Surfaxin against its comparators, the results can’t support any superiority claim.
The FDA also took issue with the company’s use of the phrase “therapeutic evolution” because it is implying that Surfaxin may be safer than animal-derived surfactants, but the “Adverse Reactions” section of the PI indicates that it isn’t.
The letter also states that other claims on the company’s website for Surfaxin, including that it’s the “only available alternative to animal-derived surfactants approved by the FDA,” are misleading because the drug is exclusively approved for the prevention of the syndrome in high-risk infants – while Curosurf, for example, is indicated for the treatment of RDS. Thus Surfaxin is not an alternative to animal-derived surfactants.
According to the letter, the PI for Surfaxin doesn’t indicate that the drug can be used to treat RDS, and sufficient information demonstrating that it’s safe and effective for this intended use wasn’t submitted to the FDA. Therefore, Surfaxin has an intended use for which it lacks approval, and its labeling fails to provide adequate direction use.