No generic substitute for Megace ES

Megace ES is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in AIDS patients.1 A reformulation of megestrol acetate oral suspension, Megace ES has demonstrated improved bioavailability for subjects in the unfed state vs. original formula Megace®.*

Megace ES and original formula Megace are not therapeutic equivalents.3 In addition, there is no generic substitute for Megace ES.3 For your AIDS patients who have lost interest in eating or are experiencing unintended weight loss, Megace ES can help them improve their appetite and gain weight, which can lead to an enhanced sense of well-being.1

Megace ES is unique and differs from original formula Megace in the following ways:

NanoCrystal® technology

Megace ES has improved on the micronized formulation of original formula Megace by utilizing NanoCrystal Technology.4 Through this technology, NanoCrystal particles are created, which are up to 50 times smaller than the micronized particles in original formula Megace. These small particles are produced and stabilized, resulting in an aqueous dispersion of the drug.4

The resulting dispersion provides increased surface area of the total drug, which leads to improved solubility and increased absorption.4 This improves bioavailability and allows for the ability to deliver the drug in a smaller volume per dose compared with original formula Megace.

Megace ES Has Greater Absorption Than Megace® in the Unfed Condition

• Megace ES offers improved bioavailability in the unfed condition vs. original formula Megace1

• There was comparable bioavailability between Megace ES and original formula Megace in the fed condition1

In clinical studies, the “fed” condition means a subject consumed a high-calorie, high-fat meal.16

• The high-calorie meal was 800-1000 calories

• The high-fat meal contained at least half of the meal’s total calories from fat


FDA example meal

An FDA example meal shown at right is 2 eggs fried in butter, 2 strips of bacon, 2 slices of toast with butter, 4 ounces of hash brown potatoes, and 8 ounces of whole milk.16


 

Less Volume and Reduced Viscosity With Megace ES

Megace ES has 75% less total volume per dose compared with Megace 800 mg/20 mL.1,17 Megace ES is also 94% less viscous than original formula Megace.6 This may be important for patients who are struggling with their ability and desire to eat.

• Megace ES is substantially less viscous than some common OTC products, including Mylanta®‡6

• Lower viscosity may make Megace ES easier to take and may be important for patients who have trouble swallowing

*Megestrol acetate oral suspension.

Clinical significance unknown. Megace ES has improved absorption over original formula Megace in people who have not eaten (the unfed state). For people who have eaten (fed condition), Megace ES and original formula Megace have similar absorption into the body. The fed condition is achieved by subjects eating a high-calorie (800-1000 calories) and high-fat (approximately 50% of total calories) meal.16

Mylanta is a registered trademark of Johnson & Johnson-Merck Consumer Pharmaceuticals Co.

 

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