Here is some competition for Delatestryl - which contributed a surprising amount of $ to BTGC the last two Q's.
Newly Approved Drug Therapies Drug Name: AndroGel testosterone gel
Company: Unimed Pharmaceuticals Inc.
Approval Status: Approved February 2000
Treatment for: For replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone
General Information
AndroGel is a hydroalcoholic gel to be applied to the clean, dry skin of the shoulders, upper arms and/or abdomen. The gel is absorbed through the skin and delivers testosterone to the patient for approximately 24 hours. This product is indicated for men with primary hypogonadism or hypogonadotropic hypogonadism which results from insufficient secretion of testosterone and is characterized by low serum testosterone concentrations.
Two types of hypogonadism for which this drug is indicated:
1. Primary hypogonadism: testicular failure; characterized by low serum testosterone levels and gonadotropins (FSH, LH) above the normal range
2. Hypogonadotropic hypogonadism: idiopathic gonadotropin or LHRH deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation; characterized by low serum testosterone levels, but with gonadotropins in the normal or low range
In addition to supplying sufficient amounts of testosterone, AndroGel?, like other drugs in its class, may promote retention of nitrogen, sodium, potassium, phosphorus, and decreased urinary excretion of calcium. Furthermore, it may increase protein anabolism and decrease protein catabolism. This class of drugs (androgens) may also stimulate the production of red blood cells.
Hypogonadism affects approximately 4 to 5 million American men.
Symptoms of hypogonadism include:
Impotence
Decreased sexual desire
Fatigue and loss of energy
Mood depression
Regression of secondary sexual characteristics (growth and maturation of prostate, seminal vesicles, penis, and scrotum; the development of male hair distribution, including facial, pubic, chest, axillary hair; laryngeal enlargement; vocal chord thickening; alterations in body musculature; fat distribution)
Osteoporosis
Clinical Results
227 hypogonadal men participated in a research study investigating AndroGel? 1%. The study was conducted in 2 phases: an Initial Treatment Period of the first 90 days and an Extended Treatment Period of the second 90 days. During both treatment stages, patients were randomized into different AndroGel? dose groups and one non-scrotal testosterone transdermal system group. The first phase investigated 5 G daily and 10 daily of AndroGel? and 5 mg daily of non-scrotal testosterone transdermal system. In the extended treatment phase, groups of patients continued with either 5 G daily or 10 G daily of AndroGel? or 5 mg daily of non-scrotal testosterone transdermal system, and an additional treatment group taking 7.5 G AndroGel? daily was added.
Results of the study showed that serum testosterone concentrations increased to the normal range within first day of treatment with doses of 5 G and 10 G. In patients continuing on AndroGel? 5 G and 10 G, these mean testosterone levels were maintained within the normal range for the 180-day duration of the study. 87% of patients whose data could be analyzed achieved normal serum testosterone level on treatment day 180.
5 G, 7.5 G and 10 G doses of AndroGel? all also significantly increased total body mass and total body lean mass and decreased total body fat mass and percent body fat. Furthermore, with 10 G AndroGel? bone mineral density in the hip and spine increased significantly.
As a result of all doses of AndroGel?, patients showed significant increases in libido and degree of penile erection and significant positive effects on mood and fatigue.
Another research study was conducted in order to investigate whether AndroGel? could be transferred through skin-to-skin contact. AndroGel? patients and their female partners engaged in daily vigorous skin-to-skin sessions. When evaluated, all unprotected females showed testosterone levels >2 times the baseline value at some point during the study. Wearing clothing, on the other hand, during skin-to-skin contact, prevented any transfer of the drug.
Jim |
