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FDA Approves Megace ES for Anorexia in AIDS Patients

WOODCLIFF LAKE, N.J., July 06, 2005 -- Par Pharmaceutical Companies, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved Megace ES (megestrol acetate), a concentrated oral suspension for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS). The approval of Megace ES represents the first branded pharmaceutical product developed by Par to be approved for marketing by the FDA. New Megace ES is an advanced formulation of megestrol acetate oral suspension, the appetite stimulant most commonly prescribed by physicians. Megace ES can be taken without regard to meals and is dosed at one-fourth the volume of the original product.

"Unintended weight loss and cachexia, also known as wasting, have been shown to be determining factors in progression of disease in AIDS patients," said Lynn Kramer, MD, senior vice president, clinical development and medical affairs. "For patients who have difficulty swallowing a large dose, or those with a lack of appetite who cannot eat without the help of medication, the approval of Megace ES is a crucial advance."

Megace ES utilizes Elan's NanoCrystal(R) Technology delivery system to improve the rate of dissolution and bioavailability of the original megestrol acetate oral suspension. Recent data have shown that the bioavailability of the original formulation is reduced substantially when taken on an empty stomach. With Megace ES, this reduction in bioavailability is minimized in the fasted state, resulting in improved bioavailability in patients who have not eaten. Megace ES 625 mg/5 mL and megestrol acetate oral suspension 800 mg/20 mL are bioequivalent in a fed state.

Patients taking Megace ES will be able to take a one-teaspoon (625 mg/5 mL) daily dose, or one-fourth of the volume of the original product. Previously, patients had to drink one 20 mL cup (800 mg/20 mL) of megestrol acetate oral suspension daily to receive the drug's full benefit. Megace ES also is 16 times less viscous (10 cP versus 163 cP) than the original formulation.

"Par Pharmaceutical is committed to the science of improving treatment solutions for patients," said Scott Tarriff, president and chief executive officer. "It is gratifying to be able to offer patients this advanced product. Improved bioavailability and reduced volume per dose of Megace ES should allow patients to receive the complete benefit of the therapy."

Efficacy of Megace ES

The FDA approval of Megace ES was based on pharmacokinetic studies demonstrating bioequivalence between 625 mg and 800 megestrol acetate oral suspension when dosed in a fed state. The clinical benefits treating patients with anorexia, cachexia, or an unexplained, significant weight loss have been clearly demonstrated AIDS. one two placebo-controlled, randomized efficacy trials AIDS, effectively stimulated appetite nine out 10 patients, increased mean caloric intake by 646 calories per day, gain 10.7 pounds versus placebo 12 weeks. also reported improved sense well being. second placebo-controlled study, seven experienced appetite, 464 13.3 placebo.

Moreover, a bioavailability study directly comparing the rate and extent of absorption of Megace ES and megestrol acetate oral suspension revealed that the Cmax level with the original formulation was 1,364 ng/mL in fed patients and 187 ng/mL in unfed patients. In contrast, the Cmax level with Megace ES was 1,517 ng/mL in fed patients and 1,041 ng/mL in unfed patients. Further, in unfed patients Megace ES achieved 5 times greater peak plasma levels than megestrol acetate oral suspension. Additionally, the study demonstrated that a lower volume of Megace ES achieved maximum blood concentration more rapidly than the currently available oral suspension products.

About Unintended Weight Loss

Anorexia (a persistent lack of appetite), unintended weight loss, and cachexia (significant weight loss that involves depletion of both fat and lean body mass) represent a serious risk in patients with AIDS. Significant weight loss and cachexia are associated with worsening illness, physical impairment, decreased tolerance of some therapeutic agents, and increased susceptibility to infection.

Important Safety Information About Megace ES

Megace ES and megestrol acetate oral suspension are contraindicated in patients with a history of hypersensitivity to megestrol acetate or any component of the formulation, or patients with known or suspected pregnancy.

Evidence of adrenal suppression has been observed in patients receiving megestrol acetate oral suspension. The glucocorticoid activity of megestrol acetate oral suspension has not been fully evaluated.

Clinical cases of new onset diabetes mellitus, exacerbation of pre- existing diabetes mellitus, and overt Cushing's Syndrome have been reported in association with the chronic use of megestrol acetate.

The most common adverse events (less than or equal to 1% and > than placebo) associated with Megace ES 625 mg/5 mL and megestrol acetate oral suspension 800 mg/20 mL are impotence, flatulence, rash, hypertension, insomnia, fever, decreased libido, dyspepsia and hyperglycemia.

Women who participated in studies (n=10) reported breakthrough bleeding; however, it is unknown if these events are drug -- or disease-related.
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Posted: July 2005