March 3rd, 2014

Pfizer Starts Testing for Over-the-Counter Atorvastatin

Looking backward to improve its future, Pfizer will once again try to gain FDA approval to market its blockbuster drug, atorvastatin (Lipitor), over-the-counter (OTC). Peter Loftus reports in the Wall Street Journal that the company has started a clinical study to support the application for low-dose atorvastatin (10 mg).

Over-the-counter statins have been unsuccessfully proposed in the past. Merck tried several times to gain approval for lovastatin (Mevacor). In 2007 an FDA advisory panel recommended against approval. And in 2011, prior to the expiration of Pfizer’s patent on Lipitor, the company said that it would pursue OTC approval.

The new study, which has been registered on ClinicalTrials.Gov, will enroll 1200 people at pharmacies in the U.S. The main outcome of the study will be to determine the percentage of patients who comply with directions on the box to check their LDL levels and who take appropriate actions based on the test result. “It’s our responsibility to demonstrate patients can safely and effectively use these products,” a Pfizer executive told the WSJ.

But the study may provide an answer to a question that is no longer being asked. New lipid guidelines released last year are based on an overall assessment of risk and do not hinge on lipid measurements. The article quotes guideline co-author Neil Stone: “The new guidelines insist on a patient-clinician discussion before a statin prescription is written.”

But, Loftus writes, “other doctors say the removal of specific cholesterol targets could make it easier for patients to take an OTC statin. Once patients know they are in a risk group identified by the new guidelines—for which the low-dose level in over-the-counter Lipitor is appropriate—they could buy the product off the shelf and not worry about treating to a specific target.”

The WSJ reports that after peaking at nearly $13 billion in 2006, Lipitor sales for Pfizer last year were $2.3 billion. An OTC version could bring in an addition $1 billion in sales each year, Goldman Sachs estimates.


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