Case 2 “PK”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

daypro piLet’s take a look at the second case. This is in pharmacokinetics. A particular brand example was Daypro, a non-steroidal anti-inflammatory drug.

The key claim for Daypro was that it could provide day-long confidence and proactive control – a tagline that was created to reflect its brand name. This was based on a PK profile that there was no drug accumulation with chronic dosing. The kidneys could be spared drug accumulation even if the patient took it once a day, every day — instead of just as needed for pain.

This became a real promotional and competitive difference for Daypro, and was reflected in its advertising and sales campaign and its prescription growth over the time this claim was made.

The regulatory lesson was that this PK difference was in the label, so we didn’t have to fight upstream to show that this was an allowable claim. It was already in the package insert and it was shown to have true patient dosing implications.

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