Pfizer has begun a clinical study in their attempt to obtain FDA-approval for over-the-counter (OTC) atorvastatin (Lipitor) in a 10mg dose. The medication is a statin that lowers LDL cholesterol, and is the largest selling drug of all time.
The study will involve 1,200 patients, enrolling them at U.S. pharmacies to determine whether they can follow instructions on the package that advise them to check their LDL levels regularly and take appropriate action as directed by those test results.
Patients know that most OTC drugs work because they relieve symptoms quickly, but high cholesterol has no symptoms. The only way to know the drug is working is to periodically get blood tests to check cholesterol levels. Determining whether people will actually follow through on this instruction is the goal of the study.
Lipitor is a type of drug known as a statin, which are a class of drugs that people typically take to lower blood cholesterol. Statins work by blocking the action of a chemical in the liver that makes cholesterol.
Another statin, Simvastin (Zocor) has been available OTC in a 10mg dose in the U.K. for nearly 10 years.
Although cholesterol is necessary for normal cell and body functions, levels that are too high can cause atherosclerosis, a condition where plaque builds up in arteries and blocks blood flow. Reducing blood cholesterol lowers the risk atherosclerosis and consequently reduces the risk of heart attack and stroke.
Side effects of statins may include headache, abdominal pain, diarrhea, and nausea, but it is widely believed that the benefits of the medication outweigh risks.
New lipid guidelines were released last year that do not rely on lipid measurements. Instead the guidelines are centered on an overall assessment of risk, based on the patient’s 10-year risk of cardiovascular disease.
Guidelines co-author Neil Stone says the new guidelines insist on a patent-clinician discussion before the statin prescription is written, a provision that makes an OTC version of the drug difficult.
But removal of specific cholesterol targets could actually make it easier to take an OTC statin, according to other doctors. Patient could buy an OTC statin once they know they are in a risk group identified by the new guidelines, without concern for hitting a specific target.
Efforts to get OTC statins approved have been unsuccessful in the past. Merck has tried several times to get OTC approval for lovastatin (Mevacor). But Pfizer may have a better chance, since Lipitor has been studied extensively. In addition, they are seeking approval for only lowest prescribed dose (10 mg). Prescription doses may be as much as 80mg.
Pfizer has studied thousands of patients taking the drug for multiple years, in many randomized clinical trials. As a result of these studies, which have demonstrated the importance of statins in the treatment of cardiovascular disease (CVD), statins have become a foundation in any CVD treatment regimen.
At its peak in 2006 Lipitor sales reached almost $13 billion. Since the patent expired sales have dropped to only 15% of 2006 levels. OTC approval will help Pfizer recapture sales lost to generic drugs made by other manufacturers.
In the past, OTC status has gotten FDA approval for many drugs to OTC status, such as Zantac and Prilosec, for ulcer and heartburn, and anti-allergy drugs such as Claritin and Zyrtec. Approvals for the switch from prescription to OTC is restricted to drugs that have been used extensively, have well understood side-effects, and are determined to be relatively safe by FDA. It is Pfizer’s contention that Lipitor fits these criteria and should therefore be approved for over-the-counter status.
Insurance companies will see a positive effect from OTC approval, since they do not pay for over-the-counter drugs. Approval will have a mixed benefit to patients. While it will be easier for them to purchase a statin over-the-counter, they will have to pay the full cost out-of-pocket, meaning they may not save any money.
If Pfizer gains approval, over-the-counter Lipitor in a 10mg dose may be available as early as 2016.
By Beth A. Balen