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ASCOT's MOCTANIN ORPHAN DRUG FOR DISSOLUTION OF GALLSTONES IS APPROVED

Executive Summary

ASCOT's MOCTANIN ORPHAN DRUG FOR DISSOLUTION OF GALLSTONES IS APPROVED and will be fully stocked at whslrs. within the next "two to three weeks," a company spokesperson said. Moctanin (monooctanoin) is now available for direct hospital orders following Oct. 29 approval by FDA, the spokesperson added. The orphan drug represents the Skokie, Illinois-based generic mfr.'s first original NDA approval. According to the FDA-approved labeling, Moctanin is indicated "as a solubilizing agent for cholesterol (radiolucent) gallstones retained in the biliary tract following cholecystectomy, when other means of reducing cholesterol stones retained in the common bile duct have failed or cannot be undertaken." The drug is sold in 120 ml sterile bottle, which represents 24 hour treatment for one patient at a rate of 3-5 ml/hour. Ascot is one of several generic firms to enter the brandname drug marketplace via the orphan drug route. Almost exactly a year ago, LyphoMed received approval to market (ITALICS)Pentam 300 (pentamadine) for pneumocystis carinii, and the firm is also developing quinacrine. Bolar is developing L-5-HTP for post-anoxic myoclonus. Chelsea made a commitment in 1984 in conjunction with Upsher Smith to develop antipyrine for monitoring the liver's drug metabolizing capacity. "Treatment results in complete stone dissolutiion about one-third of the time and in reduction of stone size in approximately another one-third of patients," the indication and usage section of the labeling notes. "When reduced in size these stones may pass spontaneously or may be more susceptible to physical extraction. Complete dissolution is much more likely when there is a single stone (almost 50%) than when there are multiple stones (about 20%)." The labeling contains a bold warning that states: "Moctanin is intended for biliary tract perfusion only and is not for parenteral use." Ascot became involved with Moctanin by responding to a Dec. 10, 1982 Federal Register notice from FDA seeking a sponsor for the compound. The notice pointed out that monooctanoin was being produced at that time in sufficient quantities by Stokely-Van Camp, which held a use-patent on the drug for dissolution of gallstones, and, therefore, the compound would have to be licensed. FDA also noted that sufficient clinical data existed supporting monooctanoin's superior efficacy to current drug therapy, sodium cholate and heparin. However, FDA added that a four week common bile duct perfusion study in dogs would be required of a sponsor that would include gross and histologic examination of the duodenum and stomach and that the reversibility of irritation caused by the drug had to be defined. An obvious marketing tack for monooctanoin, Ascot indicated, is to stress the cost benefit of drug therapy versus surgery. The direct price to hospitals is $55 per 4 oz. bottle, Ascot said. The average wholesale price (AWP) is $65. The FDA approved labeling notes that a recommended course of therapy should run from seven to 21 days, which puts the hospital cost for the drug per patient at between $385 to $1,155. At a company sponsored symposium last May, clinical investigators noted that reoperation can cost over $5,000, percutaneous transhepatic approach over $4,500, endoscopic sphincterotomy $2,300, and basket removal $1,350.
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