(Bloomberg) — Pfizer Inc. won't bring an over-the-counter version of its cholesterol pill Lipitor to the U.S. market, after a trial found that patients couldn't take the drug correctly without a doctor's help.
Pfizer's decision to kill the over-the-counter program ends a years-long effort designed to preserve sales of what was once the New York-based company's — and the world's — top-selling drug. Since losing patent protection in 2011, Lipitor's sales have fallen from more than $10 billion a year to $2.06 billion last year.
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The 1,300-patient trial studied consumers' behavior to see if they could manage their cholesterol care on their own. Patients were recruited with a toll-free number, then directed to a pharmacy where they could get a 10 milligram dose of the drug. The trial looked at whether they would check their cholesterol after starting the drug, and take the right medical action after getting the results. The tests found that they couldn't.
"It's hard enough for me to teach young physicians in training who to administer statins to, let alone to try to do that for the general public," Steven Nissen, department chair of cardiovascular medicine at the Cleveland Clinic, said in a telephone interview. "Self-treatment of something as serious as a lipid disorder is not an appropriate course of action."
While other drugs have switched from being prescribed by doctors to over-the-counter sales, Lipitor may have been the most medically ambitious.
Since 2010, eight drugs have switched from prescription to over-the-counter, including Allegra, Flonase and Nexium.
Most were allergy or antacid drugs, while Lipitor is designed to help prevent heart attacks and strokes.
Program terminated
"Based on dialogue with the FDA about the program and analysis of this data, the program was terminated," Pfizer said in a statement Tuesday.
Statins, including Lipitor, are among the world's most- prescribed drugs and are taken by millions of Americans. Guidelines issued in 2013 by two major medical associations recommended that doctors assess a patient's total cardiovascular risk, and talk with the patient before starting treatment with a statin.
Since their introduction, many statins have gone generic and are cheaply available with a prescription. "It is very feasible for patients to benefit from these therapies to obtain any one of a handful of statins at a very low cost," Mary Walsh, vice president of the American College of Cardiology, said in a telephone interview. "I don't think there is a specific benefit for a given individual to be able to buy it over the counter without consultation."
Lipitor is still projected to be a blockbuster for years to come — analysts estimate that the pill will have sales of $1.74 billion in 2020. The vast majority of the drug's current sales are from outside the U.S.
"Lipitor continues to be a very important prescription medicine in many markets around the world," Sally Beatty, a Pfizer spokeswoman, said in an e-mail.
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