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Executive Summary

BIO PRODUCTS' Q-VEL QUININE/VITAMIN E COMBO FOR LEG CRAMPS is superior to placebo, quinine sulfate alone, and vitamin E alone, the Ketchum subsidiary maintained in a recent submission to FDA seeking Category I status of the combination in the OTC monograph for treatment and prevention of nocturnal leg muscle cramps. FDA classified both quinine sulfate and vitamin E as Category III in the leg cramp tentative final monograph, published in the Nov. 8, 1985 Federal Register. Bio Products submitted two studies in support of a Category I classification. One trial, a multi-centered, double-blind study, compared the Q-Vel combo product (quinine sulfate 64.8 mg and vitamin E 400 I.U.) to quinine sulfate, vitamin E, and placebo in 205 patients with a history of nocturnal leg muscle cramps. The firm noted that FDA assisted in planning the study protocol. "The Q-Vel combination of quinine sulfate and vitamin E was found to be statistically significantly superior to quinine sulfate and vitamin E alone on 11 of [the] 12 [efficacy] variables plus the patient's global evaluation," the firm reported. All three of the positive treatment regimens in the study "were superior to placebo on the 12 variables analyzed, as well as the patient's global evaluation," Bio Products said. Schering-Plough subsidiary Scholl also submitted a recently completed study in support of Category I classification for its Legatrin (quinine sulfate) leg cramp product. In January, Scholl submitted a study evaluating a 260 mg dose of quinine v. placebo for the treatment and prevention of nocturnal leg cramps. The new study evaluated a 325 mg dose, the highest dose cited by FDA in the TFM as being possibly safe and effective. The Scholl study considered three efficacy variables over a 10 week period: frequency of cramps; severity of cramps; and number of nights per week that cramps occurred. The double-blind study randomized 62 patients to receive either placebo or 325 mg quinine sulfate during weeks three and four. Patients were then crossed over for treatment during weeks seven and eight. The firm reported that "quinine significantly reduced the frequency of cramps compared to placebo when placebo was administered first and quinine second (p < 0.01) [and] there was no difference when quinine was administered first and placebo second." Both "quinine and placebo significantly reduced severity of cramps compared to baseline," Scholl said; however, "there was no significant difference between quinine and placebo with regard to reduction of the severity of cramps." With respect to the number of nights in which cramps occurred, the firm reported that "quinine was significantly better (p < 0.01) in reducing the nights of cramping compared to placebo when placebo was administered first and quinine second; however, there was no significant difference between the two when quinine was given first and placebo second."

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