Abbott Receives U.S. FDA Approval for AndroGel® 1.62% to Treat Men with Low Testosterone

New, Low-Volume Formulation to Help Restore Low Testosterone Levels in Men

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Apr 29, 2011, 03:00 ET

ABBOTT PARK, Ill., April 29, 2011 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has approved AndroGel® (testosterone gel) 1.62%, a clear, odorless, gel formulation shown to restore testosterone levels in hypogonadal men with half the volume of gel at the starting dose compared to AndroGel 1%. At the starting dose, the new AndroGel 1.62% contains 40.5 mg of testosterone in two pump presses, whereas AndroGel 1% contains 50 mg of testosterone in four pump presses. Dosage and administration for AndroGel 1.62% differs from AndroGel 1% and the two are not interchangeable. Both AndroGel 1.62% and AndroGel 1% are prescription medications used to treat adult males with low or no testosterone, also known as hypogonadism.

"Low testosterone is a real concern for many men, and it is important that men exhibiting signs and symptoms talk to their doctor about appropriate testing and treatment," said Natan Bar-Chama, M.D., director of Male Reproductive Medicine and Surgery, The Mount Sinai Hospital in New York. "AndroGel 1.62% is an important new option that was shown in a clinical trial to restore and maintain testosterone levels in men for up to one year."

Nearly 14 million men in the United States may have low testosterone levels. The Endocrine Society developed guidelines for the diagnosis and treatment of hypogonadism, which note the normal range for testosterone as 300-1,000 ng/dL.

"AndroGel 1% has been trusted by patients and physicians for more than a decade," said Jim Hynd, divisional vice president, Metabolics, Abbott. "With the approval of AndroGel 1.62%, Abbott now offers another innovation in testosterone delivery for men with hypogonadism to treat their condition."

AndroGel 1.62% is expected to be available to patients in the second quarter of 2011.

About Low Testosterone

Male hypogonadism (or low testosterone) is a condition in which the body does not produce enough testosterone, the hormone that plays an important role in a man's growth and development. Signs and symptoms associated with male hypogonadism include erectile dysfunction and decreased sexual desire, fatigue and loss of energy, depressed mood, osteoporosis and a diminishment in the physical characteristics of a man, such as decreased body hair.

About the AndroGel 1.62% Clinical Program

The FDA approval of AndroGel 1.62% was based on a two-phase, 364-day controlled clinical study. The first phase was a multi-center, randomized, double-blind, parallel-group, placebo-controlled study of 274 hypogonadal men. All eligible patients received AndroGel 1.62% (dosed at 20.25 mg, 40.5 mg, 60.75 mg, or 81 mg) or placebo once daily and returned to the clinic for periodic testosterone assessments. The primary endpoint was the percent of patients achieving normal average testosterone levels (300-1,000 ng/dL) on day 112. A total of 191 patients agreed to continue in an open-label, active treatment maintenance period of the study for an additional 182 days.

The study found the majority of hypogonadal men (82 percent) who took AndroGel 1.62% achieved a normal average testosterone level at day 112. For those taking AndroGel 1.62%, the average testosterone level achieved at day 112 was 561 ng/dL.

During the open-label active treatment maintenance period, 78 percent of men who received AndroGel 1.62% for one year had an average testosterone level in the normal range at day 364. The most common side effects reported with use of AndroGel 1.62% are increased prostate specific antigen (a test used to screen for prostate cancer), mood swings, high blood pressure, increased red blood cell count, and skin irritation where AndroGel 1.62% is applied.

AndroGel 1% and 1.62% Use

AndroGel® (testosterone gel) 1% and 1.62% are prescription medicines used to treat adult males who have low or no testosterone. It is not known if AndroGel is safe or effective in children younger than 18 years old.

AndroGel 1% and 1.62% Important Safety Information

Signs of puberty that are not expected have happened in young children who were accidentally exposed to testosterone through skin-to-skin contact with men using AndroGel. Women and children should avoid contact with the unwashed or unclothed application area where AndroGel has been applied. If a woman or child makes contact with the AndroGel application area, the contact area on the woman or child should be washed well with soap and water right away.

Stop using AndroGel and call your healthcare provider right away if you see any signs and symptoms of puberty in a child, or changes in body hair or increased acne in a woman, that may have occurred through accidental exposure to AndroGel. AndroGel must not be used in men with breast cancer, known or suspected prostate cancer, or in women who are pregnant, may become pregnant, or are breastfeeding. AndroGel may harm the unborn or breastfeeding baby.

AndroGel can cause serious side effects, including worsening symptoms of an enlarged prostate, possible increased risk of prostate cancer, lower sperm count, swelling of ankles, feet, or body, enlarged or painful breasts, problems breathing during sleep, and blood clots in the legs. The doctor should be notified about all the medicines taken by the patient especially insulin, medicines that decrease blood clotting, or corticosteroids. AndroGel is flammable until dry. Let AndroGel dry before smoking or going near an open flame.

The most common side effects reported with use of AndroGel 1.62% are increased prostate specific antigen (a test used to screen for prostate cancer), mood swings, high blood pressure, increased red blood cell count, and skin irritation where AndroGel 1.62% is applied.

The most common side effects reported with use of AndroGel 1% are acne, skin irritation where the gel is applied, increased cholesterol levels, increased prostate specific antigen, increased red blood cell count, and increased liver function tests.

Dosage and administration for AndroGel 1.62% differs from AndroGel 1%. AndroGel is not interchangeable with other topical testosterone products.

For additional safety information about AndroGel 1.62%, please see the medication guide at (http://www.rxabbott.com/pdf/androgel1_62_medguide.pdf) or full Prescribing Information at (http://www.rxabbott.com/pdf/androgel1_62_PI.pdf).

For additional safety information about AndroGel 1 %, please see the medication guide at (http://www.rxabbott.com/pdf/androgel_medguide.pdf) or full Prescribing Information at (http://www.rxabbott.com/pdf/androgel_PI.pdf).

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information are available on the company's website at www.abbott.com.

SOURCE Abbott