MEDICINAL FOODS FIELD IS FERTILE GROUND FOR OTC PRODUCT DEVELOPMENTS, THOMPSON MEDICAL EXECUTIVE TELLS P-A ANNUAL MEETING: SEDATIVE TRYPTOPHAN IS EXAMPLE

Tryptophan as a daytime sedative, hypnotic and sleeping aid is an example of the potential for new OTC products which could develop out of the "medicinal foods" category, Thompson Medical VP-Scientific Director Harold Silverman told the Proprietary Association annual meeting on May 12. "Tryptophan has waffled out there in the wind [between being viewed as a good or a drug] for a number of years," Silverman said. He maintained, however, that "the research is there" to support its use in the sedative/hypnotic drug class. Glucomannan and fiber were cited by Silverman as "very useful as bowel regulators, certainly as obesity preventives, and definitely to control cholesterol." He noted that Procter & Gamble could pioneer the OTC fiber cholesterol control use with a claim for Metamucil ("The Pink Sheet" April 6, T&G-9). The medicinal foods category, Silverman said, is "particularly interesting" as a source for future OTC products. "There are in this area a number of useful, interesting products which border on whether or not they are drugs or foods, but [which] have dramatic impact benefiting the health of the person who utilizes them in an appropriate way." Silverman did not specifically refer to P&G's "fat replacement" product, polyester sucrose. However, that product, which P&G intends to clear through FDA as a food additive, could exemplify a new generation of foods with medicinal/preventive claims which have substantial drugstyle clinical study backgrounds. P&G recently announced filing a food additive petition for the ingredient under the generic name of olestra ("The Pink Sheet" May 11, T&G-1). Silverman urged the OTC industry "not to default" to the food industry in educating the consumer about the benefits of new preventive products. "This is an area were we have done some, but we haven't done anywhere near enough. The food industry is doing an awful lot" in the area, Silverman said. To indicate the growing popularity of the OTC/medicinal food category, Silverman cited calcium for moderate osteoporosis, omega-3 fish oils for protection against cardiovascular disease, atherosclerosis, and rheumatoid arthritis, and lecithin (phosphatidyl choline) to delay or prevent Alzheimer's Disease. Silverman maintained that there have been "some elegant papers" to suggest the usefulness of the ingredient in that role. In addition to the medicinal foods, the Thompson Medical scientific director suggested a number of categories and product packaging and dosage formulations that could offer new OTC products. For example, Silverman touted the reformulation of charcoal as offering a product with "untold uses" for an entrepreneurial formulation firm. "It is dirty and inelegant, but it is more effective than simethicone for gas," Silverman contended. Charcoal is also useful, Silverman said, for helping to ameliorate the problem of diarrhea and "very quickly and very effectively reducing blood pressure, decreasing overall cholesterol and increasing high density lipoproteins." He also mentioned the combination of bismuth subsalicylate and attapulgite as a potentially interesting product for the antidiarrheal class. He maintained that P&G's efforts to move bismuth subsalicylate into Category I will be successful and will provide the possibility of combining two antidiarrheals, each of which work in a different fashion. "I submit," Silverman said, "that in accordance with the OTC combination policy, it is perfectly logical to put these two products together with electrolytes and we would have indeed a superior product to treat diarrhea." In the oral health care field, Silverman sees significant potential for antigingivitis treatments. He noted, for instance, that a product exists in Europe for providing peroxide to the teeth to help inhibit the development of gingivitis. Arguments could be made, Silverman suggested, for use of chlorhexidine in the oral cavity. The product is available OTC for use in ophthalmic products, Silverman observed. "I submit that a very good case could be made for chlorhexidine to be used on an OTC basis in the oral cavity since it is used in the mucus membrane of the eye." Silverman further predicted that Rx periodontal mouthwashes will soon be moved to OTC use. New niche indications for existing OTC ingredients include the potential use of phenylpropanolamine, pseudoephedrine, and ephedrine to treat eneuresis. He said that is an area for "development of a solid, ethical proprietary drug." To facilitate new categories for the self-medication industry, Silverman declared that the industry must work to educate the consumer "away from the concept that OTCs are safe regardless of how they are used, and that they may do some benefit -- sometimes -- but that they are not, in any real sense strong medicine." Silverman said the industry should try to portray the similarities between OTC medications and Rx drugs and point out that OTCs are in many ways "comparable" to Rx products.