- In a trial of 1,300 patients, researchers found that patients could not comply with the necessary protocol for Lipitor (atorvastatin), which is used to lower cholesterol levels.
- Pfizer was hoping to preserve sales of Lipitor, which lost patent protection in 2011, by making it an OTC drug.
- Pfizer and the FDA discussed the trial failure before deciding to terminate the program.
The strategy of taking an off-patent, former blockbuster prescription drug and redeploying it as an OTC drug sometimes works. In fact, since 2010, eight former Rx drugs have become OTC drugs, including Allegra, Flonase, Nexium and others. However, while it may be relatively easy for a patient to self-administer drugs for allergies or antacid, self-medication with cholesterol-lowering drugs is another thing entirely, as the researchers discovered.
After patients with hypercholesterolemia were recruited for the study via a toll-free number, they were directed to a pharmacy and provided with a 10-mg dose of Lipitor. They were then supposed to start taking the drug, check their cholesterol and take the correct medical action based on the outcome. It turned out that overall, patients were noncompliant—either they could not or would not follow the instructions, and encouraging compliance would require a doctor's assistance.
Generic statins are abound, and are readily available via prescription—along with counseling from a healthcare provider. Since 2010, Liptior's sales have gone from roughly $10 billion to a little more than $2 billion, but Lipitor is still considered a 'blockbuster' in the traditional sense of the word (sales of $1 billion or more). Nonetheless, most of the sales are ex-US and Pfizer has decided to stop trying to use an OTC strategy to regain market share in the U.S.