CHADDS FORD, Pa., March 3, 2011 /PRNewswire/ -- Endo Pharmaceuticals (Nasdaq: ENDP) announced that FORTESTA™ Gel – recently approved by the U.S. Food and Drug Administration for the treatment of low testosterone, or 'Low T' in adult males – is now available by prescription in pharmacies across the country. The clear, colorless and odorless gel comes in a small (60 g) canister with a pump that delivers 10 mg of testosterone with each actuation (pump). FORTESTA Gel is applied once-a-day with one finger directly to the front and inner thighs – not to the upper body.
The introduction of FORTESTA Gel in the U.S. comes at a time when only about 1.3 million (9 percent) of the estimated 14 million men with Low T are actually receiving treatment.
"We are excited to bring FORTESTA Gel to market in the United States and are confident that once men try it, FORTESTA Gel will quickly become a significant treatment option for many men with Low T," said Julie McHugh, Chief Operating Officer, Endo Pharmaceuticals. "Endo is committed to providing additional treatment options for the millions of men with Low T who are currently not being adequately treated for the condition."
In a 90-day, multicenter, open-label, non-comparative, pivotal Phase III trial involving men with hypogonadism, 78 percent of patients using FORTESTA Gel had an average testosterone blood level within the normal range at day 90. The most common side effect in this trial was application site reactions.
For more information about FORTESTA Gel, visit www.FortestaGel.com.
Important Safety Information for FORTESTA™ Gel
FORTESTA Gel can transfer from your body to others. This can happen if other people come into contact with the area where the FORTESTA Gel was applied. Signs of puberty that are not expected (for example, pubic hair) have happened in young children who were accidentally exposed to testosterone through contact with men using topical testosterone products like FORTESTA Gel.
Women and children should avoid contact with the unwashed or unclothed areas where FORTESTA Gel has been applied. If a woman or child makes contact with the FORTESTA Gel application area, that area on the woman or child should be washed well with soap and water right away.
To lower the risk of transfer of FORTESTA Gel from your body to others, you should: Apply FORTESTA Gel only to the front and inside area of your thighs that will be covered by clothing and wash your hands right away with soap and water after applying FORTESTA Gel. After the gel has dried, cover the application area with clothing and keep the area covered until you have washed the application area well or have showered. If you expect another person to have skin-to-skin contact with your thighs, first wash the application area well with soap and water.
Stop using FORTESTA Gel and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have occurred through accidental exposure to FORTESTA Gel.
Do not use FORTESTA Gel if you have breast cancer, have or might have prostate cancer, are pregnant, may become pregnant, or are breastfeeding.
FORTESTA Gel may harm your unborn or breastfeeding baby. Women who are, or who may become pregnant should avoid contact with the area of skin where FORTESTA Gel has been applied.
Other possible serious side effects include: if you already have enlargement of your prostate gland your signs and symptoms can get worse while using FORTESTA Gel; possible increased risk of prostate cancer; in large doses FORTESTA Gel may lower your sperm count; swelling of your ankles, feet, or body, with or without heart failure; enlarged or painful breasts; have problems breathing while you sleep (sleep apnea); increased red blood cell count; blood clots in the legs (his can include pain, swelling or redness of your legs). Call your healthcare provider right away if you have any of the serious side effects listed above.
Tell your HCP about all of your medications, especially insulin, medicines that decrease blood clotting, and corticosteroids.
The most common side effects of FORTESTA Gel include skin redness or irritation where FORTESTA Gel is applied, increased prostate specific antigen (PSA), and abnormal dreams.
Full prescribing information, including the Medication Guide, is available at www.FortestaGel.com.
About Low Testosterone
Low testosterone or 'Low T,' also known as hypogonadism, is a condition in men characterized by the body's failure to produce normal amounts of the hormone testosterone, a male sex hormone produced by the testes. Low T affects nearly 14 million men in the United States, yet only 9 percent (1.3 million) of men diagnosed with Low T are receiving treatment for the condition. Symptoms associated with Low T include erectile dysfunction and decreased sexual desire, fatigue, loss of energy, mood depression, regression of secondary sexual characteristics and osteoporosis.
Endo Pharmaceuticals is a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics. Endo is redefining its position in the healthcare marketplace by anticipating and embracing the evolution of health decisions based on the need for high-quality and cost-effective care. We aim to be the premier partner to healthcare professionals and payment providers, delivering an innovative suite of complementary diagnostics, drugs, devices and clinical data to meet the needs of patients in areas such as pain, urology, oncology and endocrinology. For more information about Endo Pharmaceuticals, and its wholly owned subsidiary HealthTronics, Inc., please visit www.endo.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect our current views, expectations and beliefs concerning future events, these forward-looking statements involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption "Risk Factors" in our Form 10-K, Form 10-Q and Form 8-K filings with the Securities and Exchange Commission and as otherwise enumerated herein or therein, could affect our future financial results and could cause our actual results to differ materially from those expressed in forward-looking statements contained in our Annual Report on Form 10-K. The forward-looking statements in this press release are qualified by these risk factors. These are factors that, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
For an explanation of Endo's reasons for using non-GAAP measures, see Endo's Current Report on Form 8-K filed today with the Securities and Exchange Commission.
SOURCE Endo Pharmaceuticals