Par: Study shows MA-CS 575 causes faster weight gain than Megace MA-OS 800 in HIV patients

By E. Janene Geiss

Philadelphia, Dec. 19 - Par Pharmaceutical Cos. Inc. said Monday the results of a pilot study showed that 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 oral suspension)

In the 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, according to a company news release.

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, officials said.

Statistical differences in body weight gain were seen between treatments by the first week and were observed for the majority of time points through the 12th week in favor of MA-CS, officials said.

"Despite advances in antiretroviral therapy, significant weight loss remains a common and serious complication for individuals infected with the AIDS virus," Christine Wanke of the Tufts University School of Medicine and senior author of the study said in the release. "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."

The study used a concentrated suspension of megestrol acetate, MA-CS 575 mg/5 mL, formulated using NanoCrystal technology.

MA-OS 800 mg/20 mL is an appetite stimulant approved by the Food and Drug Administration 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 FDA approved Megace ES 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 using NanoCrystal technology have increased absorption, allowing for a smaller dose and volume than the MA-OS formulation, officials said.

The results of the study were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, D.C.

In 2005, Par received approval for and introduced Megace ES, its first branded pharmaceutical product. Through its collaboration with Valeant Pharmaceuticals North America, Par expects to launch a second branded drug, Cesamet, in early 2006.

Par, based in Spring Valley, N.Y., develops, manufactures and markets generic drugs and branded pharmaceuticals for specialty markets.

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