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BRISTOL-MYERS SQUIBB'S MEGACE(R) ORAL SUSPENSION APPROVED FOR THE TREATMENT OF SIGNIFICANT WEIGHT LOSS DUE TO AIDS

 PRINCETON, N.J., Sept. 15 /PRNewswire/ -- Bristol-Myers Squibb Company (NYSE: BMY) announced today that it has received clearance from the U.S. Food and Drug Administration to market MEGACE(R) (megestrol acetate) Oral Suspension.
 The drug is indicated for the treatment of anorexia, cachexia or an unexplained, significant weight loss in patients with acquired immunodeficiency syndrome (AIDS).
 The vast majority of people with advanced AIDS suffer significant weight loss which is defined as a loss of more than 10 percent of ideal or usual body weight.
 MEGACE Oral Suspension is a synthetic derivative of the naturally occurring steroid hormone progesterone. Results from a clinical trial comparing 800 mg of MEGACE Oral Suspension daily to placebo showed that patients who received MEGACE(R) Oral Suspension had a statistically significantly larger increase in mean maximum weight change than patients receiving placebo. Patients' assessments of weight change, appearance, appetite, and overall perception of well-being (as measured by a nine question survey) at the time of maximum weight change were also statistically significantly improved in the MEGACE Oral Suspension treated group versus those receiving placebo. The most common adverse events observed at this dosage were diarrhea, rash, impotence, edema, flatulence and weakness. Most of these events were seen with equal frequency among individuals receiving placebo. The complete adverse event profile is listed in the product package insert.
 "Although other substances have been approved to stimulate appetite, MEGACE Oral Suspension is the first drug shown to enhance lean body weight and muscle mass," said Jamie Von Roenn, M.D., associate professor of Medicine, Northwestern University and lead investigator of one MEGACE clinical trial. Severe weight loss may increase patient anxiety, morbidity, and debilitation, according to Dr. Von Roenn. "Patients who take MEGACE Oral Suspension feel that the change in weight has a significant impact on their health. They are less concerned about their weight and believe that there is an improvement in their overall well-being," she said.
 MEGACE(R) Oral Suspension will be manufactured in bottles containing eight ounces at a concentration of 40 mg/ml megestrol acetate. This formulation will provide a single dose of 400 mg or 800 mg in a convenient, easy-to-use dosage cup packaged with each bottle. The lemon- lime flavored suspension can be taken once daily.
 The cost of MEGACE Oral Suspension will depend on the dosage prescribed and duration of therapy. It is anticipated that most patients will begin therapy with MEGACE Oral Suspension at the recommended dose of 800 mg per day, adjust the dose to 400 mg after one month, and continue on treatment for a total of four months. The projected net effective weighted average cost of MEGACE Oral Suspension across all methods of distribution will be approximately $69.88 per
bottle or $3.49 per day of therapy. Assuming six bottles of MEGACE


Oral Suspension will be prescribed over a 120 day period, the average cost of a course of therapy will be less than $500.
 At the full wholesale list price of $83.04 per bottle, which is the highest of the prices Bristol-Myers Squibb will charge for MEGACE Oral Suspension, therapy would cost an average of $4.15 per day. Bristol- Myers Squibb has expanded its Reimbursement Assistance Program to help secure reimbursement for MEGACE Oral Suspension.
 MEGACE(R) Oral Suspension will also be made available free of charge to all patients who do not have adequate insurance coverage and cannot afford the medication. This is in keeping with Bristol-Myers Squibb's long-standing commitment to provide universal access to medication such as MEGACE Oral Suspension regardless of the patients' ability to pay.
 Bristol-Myers Squibb is a research-based, diversified health care company whose principal businesses are pharmaceuticals, consumer products, nutritionals and medical devices. It is among the world's leading makers of cardiovascular, anticancer, anti-infective, central nervous system and dermatological drug therapies, diagnostic agents and non-prescription medications.
 Please see package insert for complete prescribing information for MEGACE Oral Suspension.
 MEGACE(R) (MEGESTROL ACETATE) ORAL SUSPENSION FACT SHEET
 Brand Name Megace(R) Oral Suspension
 Generic Name Megestrol Acetate
 Class of Drug Synthetic derivative of the hormone
 progesterone.
 Formulation Lemon-lime flavored suspension containing
 40 mg megesterol acetate per ml.
 Mechanism of Action MEGACE Oral Suspension stimulates
 appetite by metabolic processes which are
 active at the cellular level. The exact
 mechanism is unknown.
 Indication MEGACE Oral Suspension is indicated for
 the treatment of anorexia, cachexia or an
 unexplained significant weight loss in
 people diagnosed with acquired
 immunodeficiency syndrome (AIDS).
 Dosage The recommended initial dose is 800 mg
 per day. In clinical trials evaluating
 different dose schedules, doses of 400
 and 800 mg per day were found to be
 clinically effective.
 Contraindications As a diagnostic test for pregnancy.
 Known or suspected pregnancy.
 Clinical Activity The efficacy of MEGACE Oral Suspension
 was evaluated in two multicenter,
 randomized, double-blind, placebo-
 controlled trials.
 These studies showed that patients
 receiving MEGACE Oral Suspension
 experienced significantly greater
 increases in mean maximum weight change
 than patients in the placebo treated
 group. Mean weight increased from
 baseline to last evaluation in 12 study
 weeks by 7.8 pounds and 11.2 pounds in
 the 800 mg MEGACE-treated groups, 4.2
 pounds in the 400 mg MEGACE-treated
 group, and decreased in the placebo
 groups by 1.6 pounds and 2.1 pounds.
 Patients' subjective assessment of weight
 gain on their sense of well-being was
 positive, particularly when compared to
 placebo in the two pivotal trials.
 Patients described improved appetites and
 less concern about weight. Overall, they
 described MEGACE| Oral Suspension as
 having been beneficial.
 Results from both trials indicated that
 patients receiving 800 mg per day of
 MEGACE Oral Suspension had a
 statistically significantly larger
 increase in mean maximum weight change
 than patients receiving placebo.
 Adverse Events The most common adverse events observed
 at a dosage of 800 mg per day were
 diarrhea, rash, impotence, edema,
 flatulence and weakness. Most of these
 events were seen with equal frequency
 among individuals receiving placebo. The
 complete adverse event profile is listed
 in the product package insert.
 How Supplied MEGACE Oral Suspension is supplied in
 eight ounce bottles containing 800mg per
 20ml with a calibrated cup providing 10
 ml and 20 ml doses.
 /delval/
 -0- 9/15/93
 /CONTACT: Robert Laverty of Bristol-Myers Squibb, 609-252-5551, or Mary Ellen Hutcherson of Ketchum Public Relations, 202-638-4339, for Bristol-Myers Squibb/
 (BMY)


CO: Bristol-Myers Squibb Company; Food and Drug Administration ST: New Jersey IN: MTC SU: PDT

MP-CC -- PH004 -- 2078 09/15/93 08:40 EDT
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Date:Sep 15, 1993
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