Pfizer, the maker of Lipitor, is pushing forward with efforts to sell its drug to patients without a doctor’s prescription, according to the Wall Street Journal.
The company recently launched a 1200-patient study to investigate whether patients could successfully take over-the-counter (OTC)atorvastatin to lower their LDL-cholesterol levels. Patients in the trial, which is currently recruiting at 35 US pharmacies, would get their own blood tests and would make decisions based on those results.
A positive study would determine whether Pfizer will file for regulatory approval of its OTC medication, according to the Journal.
Simvastatin has been available OTC at the 10-mg dose in the UK for nearly 10 years. Merck has gone before the US Food and Drug Administration three times since 2000, but the agency has turned away its drug, lovastatin (Mevacor) 20 mg, each and every time. Merck sought approval of OTC lovastatin in moderate-risk patients and aimed to market its drug to the “motivated health-conscious consumer.”
Like Merck, Pfizer says an OTC Lipitor would close the gap for people at risk of cardiovascular disease but who are not currently taking the lipid-lowering therapy.
Dr Neil Stone (Northwestern University Feinberg School of Medicine, Chicago, IL), the chair of the American College of Cardiology (ACC)/American Heart Association (AHA) guidelines for the treatment of cholesterol, told the Journal the new guidelines do not support OTC use of statins. In fact, the new guidelines don’t recommend treating to LDL targets any longer but instead recommend a moderate- or high-potency statin based on patient’s 10-year risk of cardiovascular disease.
Given that Pfizer is investigating the feasibility of just a 10-mg dose of Lipitor, undertreatment is a concern. “There’s a chance that a lot of people would take less than needed,” Dr Steven Nissen (Cleveland Clinic, OH) told the Journal.
At one stage, Lipitor was the world’s biggest-selling drug, with sales peaking at $13 billion in 2006, but since the patent expired sales have declined to $2.3 billion in 2012, reports the Journal.