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Title: Patients With HIV-Associated Wasting Gain More Weight With Concentrated Form of Megestrol Acetate, Study Shows

"Patients With HIV-Associated Wasting Gain More Weight With Concentrated Form of Megestrol Acetate, Study Shows"

SPRING VALLEY, NY -- December 19, 2005 -- Patients with HIV-associated unintended weight loss were shown to gain more weight, more rapidly when taking a daily regimen of megestrol acetate concentrated suspension 575 mg/5mL (MA-CS 575 mg/5 mL) than those patients receiving megestrol acetate oral suspension 800 mg/20 mL (MA-OS 800 mg/5ml, Megace(R) oral suspension*), according to results of a pilot study presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). In this 12-week study involving 63 patients, both treatment groups demonstrated an increase in body weight; however, the MA-CS 575 mg/5 mL group showed a greater and earlier increase in body weight than the MA-OS 800 mg/20 mL group. There was a 10% increase in the mean body weight from baseline in patients taking MA-CS compared to a 6% increase from baseline in body weight for those taking MA-OS. Further, statistical differences in body weight gain were seen between treatments by week 1 and were observed for the majority of timepoints through week 12 in favor of MA-CS. "Despite advances in antiretroviral therapy, significant weight loss remains a common and serious complication for individuals infected with the AIDS virus," commented Christine Wanke, MD, of the Tufts University School of Medicine and the senior author on the study. "This study demonstrated that, for patients taking MA-CS 575 mg/5 mL, the increase in body weight was greater and occurred earlier than those taking MA-OS 800 mg/20 mL. When treating AIDS-associated unintended weight loss in patients, increasing body weight may help improve the patient's sense of well-being." This study utilized a concentrated suspension of megestrol acetate, MA-CS 575 mg/5 mL, formulated using NanoCrystal(R) Technology**. MA-OS 800 mg/20 mL is an appetite stimulant approved by the FDA for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS). Earlier this year, the U.S. Food and Drug Administration (FDA) approved Megace(R) ES (NanoCrystal megestrol acetate 625 mg/5 mL, Par Pharmaceutical Companies, Inc.) for the same indication as MA-OS 800 mg/20 mL. Megace ES, a concentrated megestrol acetate oral suspension formulated using the same NanoCrystal Technology used to formulate MA-CS 575 mg/5 mL, is bioequivalent to MA-OS 800 mg/20 mL in the fed state. In unfed conditions, the absorption of Megace ES is substantially less affected by food than is MA-OS 800 mg/20 mL. Megestrol acetate formulations utilizing NanoCrystal Technology have increased absorption, allowing for a smaller dose and volume than the MA-OS formulation. In addition to body weight, the study also explored caloric intake, body composition and appetite over the 12-week treatment period. The caloric intake trended higher and the increase occurred sooner for MA-CS 575 mg/5 mL compared to MA-OS 800 mg/20 mL. The increase in both lean body mass and fat mass were similar between the two groups and appetite scores increased comparably in both groups, as well. Adverse events were comparable between the two treatment groups. Important Information Megace ES 625 mg/5 mL and megestrol acetate oral suspension 800 mg/20 mL 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. 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 (>/=1% and > placebo) associated with Megace ES 625 mg/5 mL and megestrol acetate 800 mg/20 mL are impotence, flatulence, rash, hypertension, fever, decreased libido, insomnia, dyspepsia, and hyperglycemia. Women who participated in studies reported breakthrough bleeding; however, it is unknown if these events are drug- or disease-related. * Bristol-Myers Squibb Company ** NanoCrystal(R) Technology is a trademark of Elan Pharma International Limited. SOURCE: Par Pharmaceutical Companies, Inc.

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