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news.New York-based Par Pharmaceutical has received approval from the FDA for its Megace ES compound in the treatment of anorexia, cachexia or unexplained weight loss in AIDs sufferers.
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According to the company, the new Megace ES is an advanced formulation of megestrol acetate oral suspension, an appetite stimulant most commonly prescribed by physicians.
“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, senior vice president, clinical development and medical affairs at Par. “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 nanocrystal technology from Irish drug maker Elan to improve the rate of dissolution and bioavailability of the original megestrol acetate oral suspension product.
Patients taking Megace ES will be able to take a one teaspoon a day, or one-fourth of the volume of the original product, which required one 20 ml cup of megestrol acetate oral suspension daily to receive the drug’s full benefit. Megace ES is also 16 times less viscous than the original formulation.