BRAINTREE LABS' SECOND PRODUCT WILL BE PHOSLO

BRAINTREE LABS' SECOND PRODUCT WILL BE PHOSLO calcium acetate for use in controlling hyperphosphatemia in end stage renal failure. FDA approved the phosphate-binding orphan drug on Dec. 10 after a 19-month review. PhosLo received a 3C rating (new dosage form or formulation representing little or no therapeutic gain). The Braintree, Mass.-based firm has marketed the gastrointestinal lavage product GoLytely since 1984. Braintree is in the process of launching PhosLo via its small detail force and a direct mail compaign to nephrologists, renal clinics and pharmacists. In addition, Braintree will support the PhosLo introduction with a print campaign that breaks in March issues of several nephrology medical journals, including Kidney International and Nephrology News. Braintree's ad agency Larey/Wolf/Swift of New York is handling promotions and advertising. Ads will promote PhosLo's advantages over antacids for phosphate binding, including the absence of aluminum toxicity or constipation with calcium acetate. PhosLo is priced to wholesalers at $ 14.95 per 200 tablet bottle. The recommended starting dose for PhosLo is two 667 mg tablets at mealtimes. Labeling notes that the starting dose "may be increased gradually to bring the serum phosphate value below 6 mg/dl, as long as hypercalcemia does not develop." Labeling adds that "most patients require 3-4 tablets with each meal." The labeling includes a warning that administration "in excess of the appropriate daily dosage can cause severe hypercalcemia" and contraindicates use of the drug in patients with hypercalcemia. One obstacle Braintree faces in introducing PhosLo is the availability of other calcium products marketed as food supplements, including several that have been promoted for phosphate-binding. Last year, Braintree filed a patent-infringement suit versus Ashland, Ore.-based Vitaline Formulas for marketing its calcium product Phos-Ex for phosphate binding in end stage renal failure patients. In August 1990, FDA sent Vitaline a regulatory letter for marketing Phos-Ex for a drug claim without an approved NDA. In addition, FDA sent a reg letter to San Antonio-based Mission Pharmacal on Dec. 28 for promoting its Citrical calcium citrate OTC product line for "use as an aluminum-free phosphate binder in dialysis patients with end-stage renal disease."