NEW YORK, Feb. 9, 1996 -- A novel formulation of diltiazem hydrochloride (TIAZAC(TM))(1) for hypertension is now available from Forest Laboratories, Inc. The new, once-daily calcium channel blocker effectively reduces blood pressure of hypertensive patients over the 24-hour dosing interval with a side-effect profile comparable to placebo, even when dosed up to 360 mg.

Blood pressure normally varies throughout the day and night and is influenced by the patient's own circadian rhythm and external stimuli. In hypertensive patients, blood pressure needs 24-hour control to achieve blood pressure levels that approach treatment goals(2).

Through its unique extended-release, osmotic-driven diffusion system of concentrated diltiazem beads, TIAZAC(TM) delivers smooth 24-hour plasma levels, which are highly correlated with blood pressure measurements. When properly dosed, TIAZAC(TM) provides smooth and predictable 24-hour blood pressure control. A greater blood pressure reduction is achieved with TIAZAC(TM) when blood pressure is at its highest, yet TIAZAC(TM) achieves blood pressure reduction without causing hypotension during periods of lower blood pressure.

"TIAZAC(TM) provided a dose-related diastolic and systolic blood pressure reduction at each dosage level," added Gosse Bruinsma, MD, Medical Director at Forest Laboratories. "In a dose-escalation trial, seven out of ten patients responded to TIAZAC(TM) monotherapy when dosed up to 540 mg."

In clinical studies, doses of TIAZAC(TM) up to 360 mg exhibited a side-effect profile similar to that of the lower doses, and similar to placebo. Moreover, TIAZAC(TM) can be safely dosed up to 540 mg. In clinical trials, absorption of TIAZAC(TM) was not affected by food intake: TIAZAC(TM) can be taken with or without food, even high-fat meals.

"The drug delivers a consistent level of diltiazem well within the therapeutic plasma range, as evidenced by the effective 24-hour blood pressure control that diltiazem achieves," added Joel Neutel, MD, Assistant Professor of Medicine and Head of the Hypertension Research Center at the University of California at Irvine.

TIAZAC(TM), a highly concentrated formulation of diltiazem, enables more drug to be contained inside a smaller capsule. This unique formulation allows for both smaller capsules for a given dosage, relative to the same dose of other once-daily diltiazem products, and for five dosage strengths: 120, 180, 240, 300 and 360 mg. This means that TIAZAC(TM) offers physicians the widest range of available single-capsule dosages among once-daily diltiazems, allowing for maximum dosing flexibility with once-daily therapy.

TIAZAC(TM) offers a significant savings in monthly treatment costs when compared to other leading calcium channel blockers. At the most- prescribed, extended-release diltiazem dose level (180 mg), TIAZAC(tm) costs $27.84 for one month's therapy(3) compared with Cardizem(R) CD at $37.00 and Dilacor XR(R) at $32.72.

In clinical trials, TIAZAC(TM) showed no clinically significant changes in ECG readings, no increases in 2nd- or 3rd-degree AV heart block and no more than a slight decrease in heart rate. TIAZAC(TM) is well tolerated in clinical trials. No reflex tachycardia is associated with chronic use. The most commonly reported side effects were headache, peripheral edema, pain, dizziness and asthenia. First-degree AV-block has been reported infrequently (less than 1%) in clinical trials with other diltiazem products.

In a major comparative trial of single-drug therapy for hypertension, diltiazem showed blood pressure control greater than or comparable to that of six other antihypertensives from different drug classes. African- American patients in the study responded especially well to diltiazem therapy, while Caucasians responded well to all drug classes (except for a lower efficacy shown with hydrochlorothiazide in younger whites).

TIAZAC(TM), as with all diltiazem formulations, should not be used in patients with severe hypotension (less than 90 mm Hg systolic), patients with acute myocardial infarction and pulmonary congestion documented by X- ray on admission, patients with sick sinus syndrome or 2nd-/3rd-degree AV block (unless used with a functioning ventricular pacemaker) and patients who have demonstrated hypersensitivity to the drug. This drug should be used with caution in patients with impaired kidney, liver or heart function.

Forest Pharmaceuticals, a subsidiary of Forest Laboratories, Inc., is an international health care company that develops, manufactures and distributes both branded and generic forms of prescription drug products as well as nonprescription pharmaceuticals sold over-the-counter to treat a wide range of illnesses. Forest is publicly traded on the American Stock Exchange (AMEX: FRX).

(1) Full prescribing information available by calling 212-886-3113.

(2) The Fifth Report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. Bethesda, Md.: National Heart, Lung, and Blood Institute; 1994. US Department of Health and Human Services publication NIH 93-1088.

(3) Monthly costs determined from January 1996 Drug Topics(R) Red Book(R) average wholesale prices (AWP) of TIAZAC(TM), Cardizem(R) CD and Dilacor XR(R) in 90-count bottles.

AWP does not necessarily reflect actual prices paid by consumers or pharmacies.

Price comparisons are not intended to imply similar levels of effectiveness.

TIAZAC(TM), Cardizem(R) CD and Dilacor XR(R) are BC rated. Bioequivalence between these products has not been demonstrated. When switching brands of drugs, additional costs may be incurred for office visits or monitoring.

CONTACT: Joe Berwanger, 212-886-3113, or Douglas Sayles, 212-886-3057, both of GTFH Public Relations (FRX)