Par Pharmaceutical Companies Inc announced that the US FDA has accepted for filing its New Drug Application (NDA) seeking marketing clearance for megestrol acetate oral suspension NanoCrystal Dispersion (NCD).

The assigned filing date for the NDA is August 28, 2004 with a corresponding user fee goal date of April 29, 2005. On June 29, 2004, Par submitted the NDA, pursuant to Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.

The new NCD formulation is a line extension of Par's currently marketed megestrol acetate oral suspension. This advanced formulation utilizes NanoCrystal Dispersion technology to improve the bioavailability of the drug, compared to currently available formulations of the product. NanoCrystal Dispersion is a trademark of Elan Corporation, plc, Dublin, Ireland. If cleared for marketing, megestrol acetate oral suspension NCD is expected to be indicated for the treatment of anorexia, cachexia, or any unexplained, significant weight loss in patients with a diagnosis of AIDS, the company release says.

Megestrol acetate oral suspension is the generic version of Bristol-Myers Squibb Company's Megace Oral Suspension. In 2003, Par licensed the Megace brand name from Bristol-Myers Squibb for its new NCD formulation of the drug.

Megestrol acetate oral suspension NCD appears to achieve therapeutic plasma concentrations in fasting as well as fed subjects. Par's studies have indicated minimal food effect with the new NCD formulation as compared with existing formulations of megestrol acetate oral suspension. This is of particular significance when treating anorectic or cachectic patients who are typically in a fasted state, the release added.