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SEARLE’s MAXAQUIN ONCE-DAILY ORAL QUINOLONE APPROVED

Executive Summary

SEARLE's MAXAQUIN ONCE-DAILY ORAL QUINOLONE APPROVED by FDA Feb. 21 as "the first one-tablet, once-a-day, broad-spectrum quinolone" antibacterial, Searle announced Feb. 24. The product will be available to wholesalers by the end of April. The drug (lomefloxacin) is indicated for "treatment of adults with mild to moderate" complicated and uncomplicated urinary tract infections and acute bacterial exacerbations of chronic bronchitis caused by H. influenzae and M. catarrhalis, Searle said. Searle licensed lomefloxacin from the Japanese pharmaceutical firm Hokuriku Seiyaku. The NDA for lomefloxacin was filed in August 1990. The drug received a "1s" rating from FDA, indicating a new chemical entity with a standard review by the agency. Lomefloxacin is not indicated for lower respiratory infections caused by S. pneumoniae, labeling states, and it has not been shown to be safe and effective in treating urinary tract infections in patients with Pseudomonas bacteremia. Under "Geriatric Use," the label reports that 26% of patients in clinical trials of lomefloxacin were aged 65 or older. "No overall differences in effectiveness or safety were observed between these patients and younger patients." Labeling adds that "no dosage adjustment is needed for elderly patients with normal renal function." Maxaquin is available in 400 mg film-coated tablets. The recommended dosage is one a day for 10 days in bronchitis and cystitis and for 14 days in complicated urinary tract infections. "Lomefloxacin can be taken without regard to meals, the labeling states. However, when taken with food "the extent of absorption is decreased by 12%." Maxaquin is the first oral antimicrobial agent indicated to reduce infectious complications of transurethral surgery, Searle said. The drug is "indicated pre-operatively to reduce the incidence of urinary tract infections in the early postoperative period" (three to five days) after transurethral surgery. The insert advises that a single 400 mg table be taken "two to six hours prior to surgery." University of Florida clinical investigator Ira Klimberg, MD, maintained that lomefloxacin "could be a very attractive therapeutic option by offering dramatic cost savings compared to intravenous antibiotics as well as a simplification of treatment regimens when used in reducing infectious complications following transurethral surgery." Maxaquin appears to have fewer labeled uses than some of the currently marketed oral quinolones. Miles' Cipro, Ortho's Floxin and Abbott's Omniflox labels carry indications for respiratory tract infections including those caused by S. pneumoniae and urinary tract infections including patients with Pseudomonas bacteremia. Cipro, Floxin and Omniflox also are indicated for skin and skin structure infections and prostitis; Maxaquin is not. Only Maxaquin is indicated for surgical prophylaxis. Searle said the product's adverse effects "are minor and mainly nausea, headache, dizziness and photosensitivity." The label notes that the adverse clinical events "with the highest incidence" in study subjects, "regardless of relationship to drug, were nausea (3.7%), headache (3.2%), photosensitivity (2.4%), dizziness (2.3%) and diarrhea (1.4%)."
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