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."