NEW YORK — Pfizer is recruiting for a 1,200-patient actual use study to measure whether or not patients can appropriately self-select treating high cholesterol with the statin Lipitor, the Wall Street Journal reported on Sunday.
The trial is recruiting patients through more than 35 pharmacies and is expected to be completed by year-end.
The stumbling block for past statin switch applications has been the actual use study. And Pfizer may be facing an even steeper hill given that recommendations for statin drugs have become more complicated, the WSJ reported.
If approved for sale over-the-counter, Goldman Sachs estimates that a nonprescription Lipitor could generate more than $1 billion in annual sales. Presently, the best-selling OTC medicine is Pfizer's Advil, which generated $490.9 million in sales across total U.S. multi-outlet for the 52 weeks ended Dec. 29, according to IRI data. That's followed by Bayer's Aleve ($364 million) and Procter & Gamble's Prilosec OTC ($358.8 million).
CEO Ian Read shared with the WSJ that Pfizer is putting significant resources behind its over-the-counter effort and that the start of the clinical trial was "an important milestone."
Patients signing up for the trial are given an empty box featuring the proposed OTC labeling. In order to appropriately self-select, the patients must know their baseline level of bad cholesterol. In-store tests will be on hand for those patients who don't know that number.
"Among other factors, the study will track what percentage of users comply with directions to get cholesterol levels checked again in six weeks, and whether consumers should continue to take the drug if it is working, or consult with a doctor if it isn't," the WSJ reported.