Home » Drug Information » FDA Approved Drugs » 2010
Medical Areas: Endocrinology
View By:YearCompanyConditionsTherapeutic AreasDrug Names
Fortesta (testosterone gel)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Endo Pharmaceuticals
Approval Status: Approved December 2010
Treatment Area: hypogonadism
Fortesta is a clear, colorless, odorless, gel containing testosterone, an androgen. Endogenous androgens, including testosterone, are responsible for the normal growth and development of the male sex organs and for the maintenance of secondary sex characteristics. Male hypogonadism results from insufficient production of testosterone and is characterized by low serum testosterone concentrations.
Fortesta is specifically indcated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) and Hypogonadotropic hypogonadism (congenital or acquired).
Fortesta is supplied as a gel designed for topical administration via a metered-dose pump. The recommeded initial dose is 40 mg of testosterone (4 pump actuations) applied once daily to the thighs in the morning. The dose can be adjusted between a minimum of 10 mg of testosterone and a maximum of 70 mg of testosterone.To ensure proper dosing, the dose should be titrated based on the serum testosterone concentration from a single blood draw 2 hours after applying Fortesta and at approximately 14 days and 35 days after starting treatment or following dose adjustment.
The FDA approval of Fortesta was based on a multicenter, 90 day open-label, non-comparative trial in 149 hypogonadal males. Fortesta was applied once each morning to the thighs at a starting dose of 40 mg of testosterone (4 pump actuations) per day. The dose was adjusted between a minimum of 10 mg and a maximum of 70 mg testosterone on the basis of total serum testosterone concentration obtained 2 hours post Fortesta application on Days 14, 35, and 60. The primary endpoint was Cavg, the percentage of patients with steady state serum concentrations within the normal range (greater than or equal to 300 ng/dL and less than or equal to 1140 ng/dL) on Day 90. In patients treated with Fortesta, 77.5% (100/129) had Cavg within the normal range on Day 90. The secondary endpoint was the percentage of patients with Cmax above three pre-determined limits. The percentages of patients with Cmax greater than 1500 ng/dL, and between 1800 and 2499 ng/dL on Day 90 were 5.4% and 1.6%, respectively. No patient had a Cmax greater than or equal to 2500 ng/dL on Day 90. There were no clinically significant changes from baseline for sex hormone binding globulin (SHBG) (slight decrease), E2 (slight increase) and ratio of DHT to total testosterone (slight increase) at Day 90.
Adverse events associated with the use of Fortesta may include, but are not limited to, the following:
- skin reactions associated with the site of application
- prostatic specific antigen increased
- abnormal dreams
Mechanism of Action
Fortesta is a clear, colorless, odorless, gel containing testosterone, an androgen. Endogenous androgens, including testosterone, are responsible for the normal growth and development of the male sex organs and for the maintenance of secondary sex characteristics. Male hypogonadism results from insufficient production of testosterone and is characterized by low serum testosterone concentrations. Fortesta delivers physiologic amounts of testosterone, producing serum testosterone concentrations that approximate normal concentrations in healthy males. Fortesta provides continuous transdermal delivery of testosterone for 24 hours following a single application to clean, dry, intact skin of the front and inner thighs.
For additional information regarding Fortesta or hypogonadism, please visit the Endo web page.