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MERCK's PLENDIL (FELODIPINE) APPROVED WITH "1C" RATING

Executive Summary

MERCK's PLENDIL (FELODIPINE) APPROVED WITH "1C" RATING from FDA, denoting a new chemical entity with little or no therapeutic gain over existing therapies. Plendil, Merck's first calcium channel blocker, was approved by FDA on July 25 after a review period of three years and five months ("The Pink Sheet" July 29, In Brief). Plendil was approved for once-daily administration of 5-10 mg for treatment of hypertension. The calcium channel blocker "may be used alone or concomitantly with other hypertensive agents," the labeling says. "The recommended initial dose is 5 mg once-a-day" and the maximum is 20 mg a day. Plendil will be available in 5 and 10 mg tablets. Merck is not divulging its marketing plans, launch date or pricing for Plendil. The drug is entering a crowded calcium channel blocker market that includes a number of established once- a-day products such as Pfizer's Procardia XL (nifedipine) and Searle's Calan SR and Knoll's Isoptin SR (verapamil). In addition, Syntex' Cardene (nicardipine) and Sandoz/Glaxo's DynaCirc (isradipine) have been launched in the past two years. After Plendil is administered, "a reduction in blood pressure generally occurs within two to five hours," approved labeling states. "During chronic administration, substantial blood pressure control lasts for 24 hours, with trough reductions in diastolic blood pressure approximately 40-50 percent of peak reductions." Plendil causes "dose-related decreases in systolic and diastolic blood pressure as demonstrated in six placebo-controlled, dose response studies using either immediate-release or extended- release dosage forms," the labeling notes. The precautions section of Plendil's labeling addresses the drug's use in individuals with heart failure. "Although acute hemodynamic studies in a small number of patients with NYHA Class II or III heart failure treated with felodipine have not demonstrated negative inotropic effects, safety in patients with heart failure has not been established." The labeling adds that "caution therefore should be exercised when using Plendil in patients with heart failure or compromised ventricular function, particularly in combination with a beta blocker." At an American Society of Hypertension symposium held in May, Milton Packer, MD, Mount Sinai School of Medicine, discussed the importance that the ability of some antihypertensives to interrupt neurohormonal activity may play in the survival of congestive heart failure patients ("The Pink Sheet" May 27, T&G-7). Packer noted that while first generation calcium channel blockers are neurohormonal activators, some second generation calcium channel blockers, such as felodipine and amlodipine (Pfizer's Norvasc), which are chemically similar, seem to decrease neurohormonal activity. Norvasc was recently recommended for approval for treatment of hypertension and angina by FDA's Cardiovascular and Renal Drugs Advisory Committee ("The Pink Sheet" June 10, p. 3). The most common adverse effects reported with use of felodipine as monotherapy were peripheral edema and headache. Of the 730 patients who received felodipine in the clinical trials, 22.3% experienced edema, and 18.6% had headaches. "Peripheral edema was generally mild, but was age- and dose-related and resulted in discontinuation of therapy in about 4% of the enrolled patients," labeling states. The Swedish company AB Hassle initially developed Plendil. Merck has exclusive U.S. marketing rights under a 1982 joint venture arrangement with Hassle's parent, AB Astra.
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