NAD Finds Certain Claims for PLx Pharma’s Vazalore Immediate-Release Aspirin Supported; Recommends Modification or Discontinuation of Others

• “Vazalore achieves therapeutic efficacy 4 times faster than EC Aspirin.”
• “Faster … antiplatelet response than enteric coated aspirin.”
• “Vazalore delivers 2X better platelet response than enteric coated aspirin.”   
• “… more predictable antiplatelet response than enteric coated aspirin.”
• “65% lower risk of acute gastric ulcerations than plain aspirin.”
• “Vazalore vs. Aspirin: 47% lower risk of erosions or ulcers; 71% lower risk of ulcers.”
• “The Miracles of Aspirin Fully Realized.”
• “Better gastrointestinal safety” (or modify it to convey the limited message that Vazalore causes fewer erosions and ulcers in the first week of treatment than traditional immediate release aspirin).
• “A better, more efficient and safer delivery platform for active pharmaceutical ingredients. We saw something good, but had a vision to make it better.”
• That Vazalore’s delivery system allows for an experience with aspirin that is safer, more efficient, and objectively “better” than traditional aspirin.

Further, NAD recommended that the advertiser:

• Modify the claim, “Vazalore has up to 5X greater absorption than enteric coated aspirin” to avoid conveying the message that the claimed difference in absorption related to superior clinical efficacy and disclose that the reported results were limited to diabetic, obese subjects.
• Modify the claim, “fast, reliable, predictable antiplatelet activity” to disclose that it is based on testing of diabetic, obese subjects and healthy subjects. 

Once it becomes available for sale, Vazalore, which contains the same active pharmaceutical ingredient (aspirin) as other OTC products on the market, will be the only liquid-filled, immediate-release aspirin product that bypasses the stomach and is absorbed in the intestine. Vazalore is marketed under a New Drug Application for the same indications allowed for currently-marketed aspirin under FDA’s Tentative Final Monograph for oral analgesics (the “TFM”). It is also approved for the secondary prevention of heart attacks and strokes. 

The claims at issue, which appeared in online advertising, were challenged by Bayer Healthcare LLC, maker of Bayer aspirin products and pertain solely to Vazalore’s use for secondary prevention.

Although Vazalore is not currently available for sale, NAD determined that the clear purpose of PLx Pharma’s website is to generate interest in the product with both consumers and health care professionals. NAD therefore concluded that, pursuant to its Procedures regarding the scope of NAD’s jurisdiction, the challenged claims constitute “national advertising” with the purpose of “persuading the audience of the value or usefulness” of Vazalore. Thus, NAD had proper jurisdiction over the case.

NAD determined that the advertiser’s evidence was not a good fit for the challenged speed claim that “Vazalore achieves therapeutic efficacy 4 times faster than EC aspirin,” which reasonably conveys a message that Vazalore provides a meaningful, superior long-term cardioprotective benefit in a faster time than EC aspirin. NAD came to a similar conclusion with regard to the advertiser’s claim “faster . . . antiplatelet response than enteric coated aspirin” because there was insufficient evidence that “faster” was consumer relevant. NAD recommended that these claims be discontinued, however it noted that nothing in the decision prevents the advertiser from making claims about the onset of antiplatelet response for subjects taking Vazalore that is narrowly tailored to fit the evidence provided.

NAD determined that the claim that “Vazalore delivers 2x better platelet response than enteric coated aspirin,” suggests that there is a meaningful and persistent difference between the performance of the two products. However, because evidence in the record suggests that the initial differences between platelet inhibition exhibited by EC aspirin and immediate release aspirin may not persist over longer periods of time, NAD recommended that the claim be discontinued.

NAD recommended that the advertiser modify the claim “Vazalore has up to 5X greater absorption than enteric coated aspirin” to avoid conveying the message that the claimed difference in absorption related to superior clinical efficacy and disclose that the reported results were from a limited study population, diabetic, obese subjects. NAD was concerned that the results from the limited study population, obese, diabetic patients without any history of heart disease, may not be representative of the population of consumers requiring aspirin therapy for secondary prevention.

NAD recommended that the advertiser discontinue the claim “… more predictable antiplatelet response than enteric coated aspirin,” but noted that nothing in the decision prevents the advertiser from making a claim related to the predictability of Vazalore’s antiplatelet response that is narrowly tailored to fit the evidence provided.

With regard to the advertiser’s gastric safety claims, NAD determined that one message reasonably conveyed is that Vazalore materially reduces the risk of all types of ulcers, even bleeding ulcers. However, NAD determined that the advertiser’s evidence was not a good fit for such a broad message and recommended that the advertiser discontinue the claims:

• “65% lower risk of acute gastric ulcerations than plain aspirin”; and
• “Vazalore vs. Aspirin: 47% lower risk of erosions or ulcers; 71% lower risk of ulcers.”

NAD noted that nothing in the decision precludes the advertiser from making a narrower claim based on the results of its study that conveys the limited message that Vazalore causes fewer erosions and ulcers in the first week of treatment than traditional immediate release aspirin.

NAD determined that the claim “The Miracles of Aspirin Fully Realized” conveys a message that Vazalore provides a therapeutic benefit (i.e., superior cardiovascular benefits or gastrointestinal safety) beyond that of its predecessors or competitors. Because the advertiser did not provide evidence to support such a conclusion, NAD recommended that the claim be discontinued.

NAD was satisfied that the advertiser had provided a reasonable basis for the claims that there is a “new delivery system for this lifesaving drug” and “we took a different approach,” based on the fact that, once launched, Vazalore will be the only liquid filled aspirin capsule product on the market and makes use of a novel delivery system.

While NAD determined that the advertiser provided a reasonable basis for the monadic claim “fast, reliable, predictable antiplatelet activity,” NAD recommended that the claim be modified to disclose that it is based on testing of diabetic, obese subjects and healthy subjects. NAD further recommended that the claim “better gastrointestinal safety” be discontinued or modified to convey the limited message that Vazalore causes fewer erosions and ulcers in the first week of treatment than traditional immediate release aspirin. 

NAD recommended that the advertiser discontinue the unsupported comparative claim “a better, more efficient and safer delivery platform for active pharmaceutical ingredients. We saw something good, but had a vision to make it better,” as well as claims that Vazalore’s delivery system allows for an experience with aspirin that is safer, more efficient, and objectively “better” than traditional aspirin.

Finally, during the course of the proceeding PLx Pharma committed to permanently discontinue the claim “3-5 times greater antiplatelet benefit than enteric coated aspirin.” Therefore, NAD did not review this claim on its merits.

In its advertiser’s statement, PLx Pharma stated that it “will comply with NAD’s recommendations.” PLx Pharma further stated that it “respects NAD’s self-regulatory process and will incorporate NAD’s recommendations as it updates its company website and develops Vazalore’s marketing campaign.”

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