July 29, 2015
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK -- Pfizer will not bring an over-the-counter version of Lipitor to market after clinical trials showed patients were unable to take the medication without a doctor’s assistance, Bloomberg reported this morning.
During the Phase III, actual use clinical trial patients were unable to not only take the dosage of the OTC drug, but to monitor their cholesterol levels and take appropriate medical action if necessary, Pfizer said. Pfizer began its study in 2013 with 1,311 patients and it was concluded in December of 2014. Trial patients were recruited through a toll-free telephone call and those selected were directed to a pharmacy to receive a 10 milligram dose of the drug.
“Based on dialogue with the FDA about the program and analysis of this data, the program was terminated,” Pfizer said when it announced the termination of the project this week when it reported its second quarter financial results.
Steven Nissen, department chair of cardiovascular medicine at the Cleveland Clinic, told Bloomberg that it’s difficult for him to teach physicians in training which patients should be prescribed statins such as Lipitor and understood why it was difficult for the general public to follow the trials’ rules of treatment.
“Self-treatment of something as serious as a lipid disorder is not an appropriate course of action,” Nissen said.
In May, a Pfizer poll showed 38 percent of respondents said they lacked the confidence to pick the right over-the-counter drug for treatment. Additionally, 59 percent of respondents said they sought physician’s advice on choosing the right over-the-counter medication.
In 2014, the Journal of the American College of Cardiology issued new guidelines for the administration of statins, which includes an assessment of a patient’s total cardiovascular risk before prescribing the statins to treat high cholesterol. Lipitor, once the world’s best selling drug, lost more than $10 billion in sales last year as the drug has faced increased competition from generics. Patents for Lipitor ran out in 2011. Sales for the drug peaked in 2006, hitting nearly $13 billion. Last year the drug generated $2.06 billion in sales.
Despite Lipitor having lost sales over the past few years, Bloomberg’s analysts said the drug is still projected to be a “blockbuster for years to come.” Sales are estimated to be $1.74 billion through 2020, with the bulk of sales outside the United States.
It has been a difficult road for some drug companies to gain over-the-counter approval for medications. In 2007, an advisory panel for the U.S. Food and Drug Administration recommended against approval of an OTC form of Merck & Co.’s lovastatin, a cholesterol drug. Most of the drugs that have jumped to OTC status have been used in the treatment of allergies or heartburn. Since 2010, eight drugs have switched from prescription to over-the-counter, including Allegra, Flonase and Nexium, Bloomberg noted.
