CHADDS FORD, Pa. (AP) – Endo Pharmaceuticals said it received U.S. approval to market Fortesta gel to treat low testosterone in men, a condition associated with fatigue, depression and sexual problems.
Drug companies are increasingly targeting low testosterone as a potential new market opportunity. About 14 million American men are believed to have irregularly low testosterone levels, though only 1.3 million are being treated, according to the company. The exact science is not completely understood, but researchers believe low testosterone levels can lead to a loss of energy, lower libido and osteoporosis.
Analysts estimate the current U.S. market for testosterone therapies at $1.1 billion. The market size has increased 23 percent since 2005, according to IMS Health, a health data firm.
Last month Eli Lilly & Co. Inc. received Food and Drug Administration approval for its Axiron solution, a testosterone formula applied under the arms. Other gels on the market include Androgel from Abbott Laboratories and Testim from Auxilium Pharmaceuticals. Watson Pharmaceuticals also sells a testosterone patch under the brand name Androderm.
The FDA has placed warnings on all testosterone gels about the risks if the formulas rub off on children. Fortesta’s label will include the same warning, which states: “signs of puberty that are not expected have happened in young children who were accidentally exposed to testosterone through contact with men using topical testosterone products.”
Endo’s Fortesta is applied to the inner thighs instead of the chest, as with older gels.
“We believe that’s attractive because the thigh area is more likely to be covered than other areas,” said Ivan Gergel, executive vice president of research & development for Endo Pharmaceuticals.
Endo studied Fortesta in about 130 men with low testosterone. After 90 days of treatment, 78 percent of the men had testosterone levels within the normal range.
Endo said it plans to launch Fortesta in early 2011. The company licensed Fortesta from ProStrakan Group PLC in August 2009 in a deal that could be worth up to $210 million if Fortesta meets certain sales targets.
Date: December 29, 2010
Source: Associated Press