Pfizer Commences Testing For Over-The-Counter Lipitor

Hunting backward to improve its long term, Pfizer will as soon as yet again consider to gain FDA approval to market its blockbuster drug, atorvastatin (Lipitor), over-the-counter (OTC). Peter Loftus reviews in the Wall Street Journal that the company has commenced a clinical research to assistance the application for minimal-dose atorvastatin (10 mg).

Over-the-counter statins have been unsuccessfully proposed in the past. Merck attempted many occasions 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 firm explained that it would pursue OTC approval.

The new examine, which has been registered on ClinicalTrials.Gov, will enroll 1200 folks at pharmacies in the US. The main outcome of the research will be to establish the percentage of individuals who comply with instructions on the box to verify their LDL levels and who consider suitable actions based on the test end result. “It’s our responsibility to show individuals can securely and efficiently use these goods,” a Pfizer executive told the WSJ.

But the examine may supply an response to a query that is no longer being asked. New lipid tips launched last 12 months are primarily based on an overall assessment of chance and do not hinge on lipid measurements. The report estimates guideline co-author Neil Stone: “The new recommendations insist on a patient-clinician discussion before a statin prescription is written.”

But, Loftus writes, “other medical doctors say the elimination of distinct cholesterol targets could make it easier for individuals to consider an OTC statin. Once individuals know they are in a chance group identified by the new guidelines—for which the lower-dose level in in excess of-the-counter Lipitor is appropriate—they could get the product off the shelf and not fret about treating to a particular target.”

The WSJ reports that after peaking at virtually $ 13 billion in 2006, Lipitor sales for Pfizer final yr had been $ two.three billion. An OTC model could bring in an addition $ one billion in sales every single 12 months, Goldman Sachs estimates.

Pfizer Commences Testing For Over-The-Counter Lipitor