Solvay Pharmaceuticals submits supplemental NDA for AndroGel

Solvay Pharmaceuticals, Inc., has announced that it submitted a supplemental New Drug Application (sNDA) for AndroGel (testosterone gel) 1% CIII to the U.S. Food and Drug Administration (FDA) for treatment in male adolescents ages 13-17 years old with primary or secondary hypogonadism.

Solvay Pharmaceuticals also is seeking an additional indication for AndroGel in the treatment of Constitutional Delay in Growth and Puberty (CDGP) in male adolescents.

Solvay Pharmaceuticals proposes to market the product under the trade name AndroGel PD for these two indications. As part of the application for new indications, the company has requested a review of the application for Pediatric Exclusivity designation. If granted, this would extend patent protection for AndroGel by six months.

While hypogonadism is commonly associated with men ages 45 and older, it can occur in males of any age, including teens between the ages of 13-17 years old. More than 32,000 males between the ages of 13 and 17 may require testosterone therapy to initiate puberty. Combined with Klinefelter's syndrome alone, the potential population exceeds 50,000 adolescent males.

In teenage boys, low testosterone levels may prevent the development of secondary sexual characteristics such as body and facial hair. Muscle mass, bones and genitals may not develop normally, and teenagers' voices may fail to deepen. Hypogonadism can be the result of genetic conditions, such as Kallmann's syndrome and Klinefelter's syndrome, which occur at birth. Other hormone deficiencies, such as luteinizing hormone deficiency, and testicular failure also can lead to hypogonadism in teens.

CDGP is typically defined by short stature and impaired bone growth of at least one year, and a positive family history of delayed growth and pubertal development.

"AndroGel is recognized as a well-tolerated, easy-to-use, safe and effective testosterone therapy for adult men," says Alan Rogol, M.D., Ph.D. and Professor of Pediatrics at the University of Virginia. "For the adolescent population, the potential availability of AndroGel represents marked progress in the treatment of hypogonadism and CDGP."

The sNDA submission is based on two studies that evaluated AndroGel in more than 80 male adolescents with hypogonadism and CDGP for up to six months. AndroGel is a once-daily, clear, odorless topical testosterone gel approved by the FDA in 2000 for replacement therapy in men ages 18 and older for conditions associated with a deficiency or absence of endogenous testosterone. It also is the most prescribed form of testosterone therapy in the United States.

"AndroGel provides an easy alternative to deep muscle injections of testosterone for teenage boys," said Laurence Downey, M.D., president and CEO of Solvay Pharmaceuticals, Inc. "We believe that doctors and teenage boys who are waiting for convenient testosterone treatment will regard AndroGel as an alternative to existing therapies."

About the studies: -- Eighteen investigators enrolled more than 80 patients, ages 12-18 years old, in a 6-month, multi-center, open-label observational study. Patients were diagnosed with primary or secondary hypogonadism or CDGP. Patients were treated with AndroGel starting at 0.5g per day and increasing dose as indicated (up to 2.5g with a maximum titration of no more than 5g), based on the clinical need of the patient. Investigators reported increases in serum testosterone levels and clinically meaningful changes in secondary sexual characteristics like growth velocity, bone maturation and hair development as a result of treatment. The most common treatment-emergent adverse events, which were mild, included headache, cough and upper respiratory infection. It was concluded AndroGel was well-tolerated in these patients. -- Six investigators enrolled 17 patients, ages 12-18 years old, at six study centers for 12 days. Patients were treated with AndroGel at 0.5g, 1.5g and 2.5g per day, and pharmacokinetic parameters were evaluated. Male adolescent patients diagnosed with primary or secondary hypogonadism or CDGP maintained stable concentrations of testosterone throughout dosing intervals with AndroGel. There were no serious or significant adverse events during this study. The most common treatment-emergent adverse events included headache, vomiting and decreased hemoglobin. Study findings showed that patients responded well to AndroGel. About Low T

It is estimated that hypogonadism, also known as low testosterone (low T), affects more than 13 million men age 45 and older. Because symptoms of low T are subtle and often overlap with other common medical conditions, low T is frequently undiagnosed. Signs and symptoms include low sex drive, erectile dysfunction, fatigue, depressed mood, reduced muscle mass and strength, increased fat body mass and decreased bone mineral density. In younger men, low testosterone levels may reduce the development of body and facial hair. Muscle mass, bones and genitals may not develop normally, and younger men's voices may fail to deepen. Men with chronic conditions, such as obesity, diabetes and hypertension, also are more likely to have low T compared to other men. Below normal levels of testosterone can be confirmed by a simple blood test. Testosterone treatment is designed to elevate a hypogonadal male's testosterone levels into the normal physiologic range, which may alleviate symptoms related to low T. As with any medication, patients should work with their physician to weigh treatment benefits and risks.

AndroGel is a once-daily, clear, odorless topical testosterone gel approved by the U.S. Food and Drug Administration (FDA) in 2000 for replacement therapy in men ages 18 and older for conditions associated with a deficiency or absence of endogenous testosterone. AndroGel is the first testosterone gel to be approved by the FDA. It also is the most prescribed form of testosterone therapy in the United States.

AndroGel is the first and only FDA-approved testosterone gel available in a non-aerosol, metered-dose pump, which is designed to deliver 1.25 grams of testosterone gel per pump depression. AndroGel also is available in 2.5 and 5 gram packets. This gives patients two convenient ways for using AndroGel and offers physicians added flexibility to dose it from the starting dose of 5g per day to 7.5g or from 7.5g to 10g per day as needed.

Patients using AndroGel should wash their hands with soap and water after applying the gel and cover the application area with clothing to avoid contact with others until the gel has dried (4,7, A).

Androgens are contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. Geriatric patients treated with androgens may be at an increased risk for the development of enlarged prostate and prostate cancer. AndroGel is not indicated for use in women, has not been evaluated in women, and must not be used in women. Please refer to the AndroGel prescribing information for complete safety information.

Information about AndroGel may be found online at: http://www.androgel.com/. Unimed Pharmaceuticals, Inc., a wholly owned subsidiary of Solvay Pharmaceuticals, Inc., holds the exclusive rights to AndroGel in the United States.

http://www.solvay.com/.

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