MEGACE Now Approved for AIDS: New Formulation

MEGACE (megestrol acetate), a drug long approved as a
palliative treatment for certain cancers, was approved by the
FDA on September 10 for treatment of unexplained significant
weight loss, or loss of appetite, in persons with AIDS.
Because of the large doses used with AIDS (which are
inconvenient to take with the MEGACE tablets previously
approved), a new oral suspension form was also approved on
September 10. It should be in pharmacies within the next few
weeks.

In controlled studies, weight increased by an average of 7.8
to 11.2 pounds in high-dose groups, and 4.2 pounds with a
lower dose, compared to a weight loss of about two pounds
with placebo. Also improved were appetite, caloric intake,
and sense of well being. The weight gain was shown to include
lean body weight and muscle mass, not just water.

However, a followup study a year later found no difference in
survival between the treatment and placebo groups. And
impotence occurred in as many as 12 percent of the patients
at the highest dose; it appears to be reversible when the
drug is discontinued.

A suggested starting dose for most patients is 800 mg per
day, reduced to 400 mg after one month. In practice,
according to Jamie Von Roenn, M.D., lead investigator of a
MEGACE trial, patients are likely to start with the high dose
until they gain weight, then reduce the dose to maintain the
weight.

According to Bristol-Myers Squibb, the price to wholesalers
will be $4.15 per day or less; we do not know what dose was
used for this computation. For patients who need the drug but
cannot pay, physicians can call 800/788-0123 to apply for
free drug when no third-party options are available.