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Executive Summary

Procter & Gamble is seeking a cholesterol-lowering indication for its OTC laxative Metamucil via inclusion in the Final Monograph for OTC laxative drug products. In a Sept. 1 letter to FDA, P&G requested that the agency, on the basis of a new clinical data submission, "provide for psyllium hydrophilic mucilloid to be indicated as an adjunct to dietary program for the reduction of elevated serum cholesterol levels." Psyllium hydrophilic mucilloid, a soluble plant fiber, is the active ingredient in Metamucil and has Category I status as a laxative under FDA's Tentative Final Monograph for OTC laxative drug products. In support of the anticholesterol claim, P&G presented results of a randomized, double-blind, placebo-controlled clinical study of 27 males with serum cholesterol levels between 200-300 mg/dL. Half received Sugar Free Orange-flavored Metamucil, 4.3 g/t.i.d., with the other half receiving placebo. The two-center study was conducted by James Anderson, MD, University of Kentucky Medical Center. After eight weeks of treatment, the serum cholesterol of the Metamucil group had fallen from baseline by 14.8%, while declining 3.5% in those taking placebo. Low-density lipoprotein cholesterol levels declined 20.2%, compared to 2.7% in the placebo group. "The reductions in total cholesterol became progressively larger with time," the firm said, "and this trend appeared to be continuing at week eight." In addition, patient body weights did not significantly decrease during treatment, indicating that serum cholesterol reductions were not correlated to weight loss. However, high-density lipoprotein cholesterol was unaffected by Metamucil, results show, as patients in both the drug and placebo groups experienced a 6.6% reduction from baseline. The study was presented at the most recent annual meeting of the Federation of American Societies for Experimental Biology, held March 30-April 2 in Washington, D.C. ("The Pink Sheet" April 6, T&G-9). "The cholesterol-lowering effect of psyllium hydrophilic mucilloid in this study," P&G stated in the letter to FDA, "is comparable to the 10-20% reductions in cholesterol levels reported for currently available anticholesterol agents such as the bile acid sequestrants (cholestyramine and colestipol), nicotinic acid and probucol." In addition, P&G suggested professional and consumer package labeling for psyllium hydrophilic mucilloid products marketed as OTC anticholesterol agents. Proposed consumer package labeling for the OTC anticholesterol agent would include the following language: "to be used in conjunction with a dietary program, as recommended by a health professional, to reduce elevated serum cholesterol." The labeling, P&G said, should also include the precaution: "Elevated serum cholesterol is a potentially serious condition which must be diagnosed by a health professional. Periodic check-ups are recommended to ensure proper response to therapy." P&Gs Metamucil submission comes at a time of heightened public awareness about cholesterol, which along with smoking and hypertension, has been identified as a contributing factor to heart disease. By choosing the OTC monograph rather than the NDA route for its anticholesterol claim, the firm is apparently banking on its muscle as a marketer of consumer health products and the strength of the Metamucil brand. The market for an OTC cholesterol-lowering agent is a potentially large one. At a Sept. 2 press conference announcing the approval of its new prescription anticholesterol drug, Movacor (lovastatin), Merck estimated that about 10% of the U.S. population, or about 24 mil. individuals, have elevated serum cholesterol levels. One hurdle that P&G faces concerns FDA's stated position that for products to be approved for OTC use, consumers should be able "to recognize the symptoms they intend to relieve with an OTC drug product." Nevertheless, FDA has pointed out that "self-diagnosis of the condition causing the symptoms is not a necessary prerequisite to the OTC availability of drug products." "We seek exemption from the position that symptoms must be recognized," P&G stated. "A key factor in curbing the incidence and mortality of coronary heart disease will be early diagnosis and effective treatment . . . before the onset of symptoms. It is important that effective therapy be available to nonsymptomatic patients who have been diagnosed, through screening programs or normal check-ups, as having elevated serum cholesterol." The company also provided a cost analysis of Metamucil compared to currently available prescription cholesterol-lowering drugs. "Based on the 10.2 g/day dose of psyillium recommended in this submission, the monthly cost of Metamucil for cholesterol reduction is $11-12," P&G maintained. "The monthly cost of prescription products (based on an average of the recommended dose range) is at least three times higher than Metamucil."

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