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Executive Summary

PROCARDIA XL IS BEING DISCOUNTED 18% TO PROCARDIA on an AWP and patient cost-per-day basis during its launch period, and a "relative discount will probably remain" as a switch inducement for physicians and patients, Pfizer VP for Medical Affairs John Jefferis, MD, said during an Oct. 4 press "teleconference" introducing the extended release form of nifedipine. Procardia XL, approved Sept. 6 for angina and hypertension, is available in bottles of 100 in 30, 60 and 90 mg tabs at average wholesale prices (AWPs) of $ 84.24, $ 151.59 and $ 181.91, respectively. The AWP cost-per-day of a recommended starting dose for Procardia XL is $ 1.05, compared to t.i.d. Procardia at $ 1.28, according to data available from Pharmaceutical Data Services' Alpha National Prescription and Sales Report for the week ending Sept. 12. The patient cost-per-day for the once-a-day nifedipine tablets is $ 1.21 compared to $ 1.47 for t.i.d. Procardia capsules, according to PDS. The cost-per-day assumes patients are started on the same dosage of the XL as the t.i.d. form. Pfizer's price formula for Procardia XL is a fine calculation taking into consideration competing cardiovascular therapies and potential generic competition. Procardia XL falls below (on a patient per-day cost basis) Cardizem SR and Cardizem but above the ACE inhibitors and beta blockers. While priced at a discount to the original Procardia version, the product will command a premium to generic versions of the standard release nifedipine. Pfizer is further inducing patient switchover to Procardia XL by focusing on its reduced side effect profile and its constant dose level from the Alza GITS delivery system. Pfizer found that the most common side effects with Procardia XL were headache and edema; however, in a study of 776 patients, edema led only 2.7% to withdraw from the medication. Procardia patients have greater incidences of vasodilator-related side effects, including headache, flushing and dizziness, which were reduced by 50% in Procardia XL patients. Procardia XL did not elevate heart rates and did cause a fall in blood pressure upon standing, two important considerations for elderly patients, the firm noted. The drug does not elevate cholesterol levels and does not affect glucose or potassium levels, making it a favorable monotherapy for hypertensive patients and an advantageous therapy for diabetic patients with angina and/or hypertension. Procardia XL also appears to lessen the incidence of painless and painful ischemia early in the day, the so-called "a.m. surge," because its extended-release mechanism eliminates the peaks and troughs in dosing found in products which must be taken more than once a day, Pfizer said. Studies "are still in progress," on the drug's effect on the a.m. surge, George Vetrovec, MD, told the teleconference. Vetrovec is director of the adult cardiac catheterization lab at the Medical College of Virginia and the Veteran's Administration Medical Center in Richmond, Virginia. The next step would be to see if Procardia XL lessens morbidity from the a.m. attacks, he said, noting that those studies are also "in progress."

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