Home » Drug Information » FDA Approved Drugs » 2002
Medical Areas: Endocrinology | Musculoskeletal
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Auxilium Pharmaceuticals
Approval Status: Approved October 2002
Treatment Area: Low Testosterone
Testim is an externally administered testosterone supplement,
indicated for men with abnormally low levels of the hormone.
Testosterone is responsible for normal growth and development of
the male sex organs and for maintenance of secondary sex
characteristics. Abnormally low levels of testosterone are linked
to a decline in energy, decreased muscle mass, reduced bone
density, decreased libido and sexual function, fatigue and
Testim is approved for use in treating men with low testosterone
levels, but has not been clinically evaluated in males under 18
years of age.
Clinical trials of Testim involved 644 hypogonadal men treated
at more than 70 centers in six countries. Auxilium found that
Testim normalized testosterone levels and improved sexual function
and other symptoms associated with low testosterone. Of 192
hypogonadal men who were appropriately titrated with Testim and who
had sufficient data for analysis, 74% achieved an average serum
testosterone level within the normal range on treatment Day 90.
Auxilium's worldwide development program for Testim also
included a placebo-controlled testosterone replacement study, with
over 400 patients at 43 centers in the U.S.
Adverse events associated with the use of Testim may include
(but are not limited to) the following:
- Application site reactions
- Benign prostatic hyperplasia
- Decreased blood pressure
- Increased blood pressure
- Increased hematocrit/hemoglobin
- Hot Flashes
- Increased mood swings
- Smell disorder
- Taste disorder
- Spontaneous penile erection
Mechanism of Action
Testim is a novel, topical gel formulation that supplements low
levels of testosterone in men. Testim (testosterone gel) is a clear
to translucent hydroalcoholic topical gel containing 1%
testosterone and provides continuous transdermal delivery of
testosterone for 24 hours, following a single application to
intact, clean, dry skin of the shoulders and upper arms. One 5 g or
two 5 g tubes contains 50 mg or 100 mg of testosterone,
respectively, to be applied daily to the skin’s surface.
Approximately 10% of the applied testosterone dose is absorbed
across skin of average permeability during a 24-hour period.
The active pharmacological ingredient in Testim is