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New Drug Delivery System Approved for Testosterone Suppressor Agent
These new features include: a smaller 21-gauge needle for improved patient comfort; reconstitution without the use of a needle; and a shield covering the needle both before and after drug administration. The system is specifically designed to encourage compliance with OSHA (Occupational Safety and Health Administration) regulations within the medical community.
"At Watson, we understand what matters most for the physicians who prescribe our products and for the patients whose lives are impacted by them. Through these types of innovations, we are committed to developing effective, safe and convenient treatments that improve the lives of patients with urological conditions," said Edward Heimers, Jr., Executive Vice President and President of Watson's Brand Division. "The new MIXJECT(TM) drug delivery system was designed with a smaller needle size and updated features that promote OSHA compliance based on the needs and suggestions from our customers in collaboration with our partner, West."
TRELSTAR(R) is a synthetic hormone known as a luteinizing hormone releasing hormone (LHRH) agonist, which suppresses the production of testosterone in the testicles. The growth of the prostate is regulated in part by the level and activity of testosterone. TRELSTAR(R) is available in a 4-week depot formulation (TRELSTAR(R) DEPOT) and a 12-week long-acting formulation (TRELSTAR(R) LA), offering an alternative treatment for prostate cancer when orchiectomy (removal of the testicles) or estrogen administration are either not indicated or unacceptable to the patient. TRELSTAR(R) does not require refrigeration and should be stored at controlled room temperature.
TRELSTAR(R) offers reliable, sustained testosterone suppression and durable reduction in PSA (prostate-specific antigen) levels. Clinical studies with patients receiving TRELSTAR(R) demonstrated that greater than 94 percent of all patients maintained castrate testosterone levels (50 ng/dL) from months two through nine. In that time period, the mean testosterone concentrations were maintained below 20 ng/dL in 96 percent of patients treated with TRELSTAR(R) DEPOT and 92 percent treated with TRELSTAR(R) LA. PSA levels in these studies also were reduced by 97 percent through month nine. Patients participating in clinical trials reported that TRELSTAR(R) administration was well tolerated, with a low incidence of injection site pain.
Important Safety Information
In clinical trials, the most common adverse events occurring in patients were hot flushes, skeletal pain, impotence and headache. As with all LHRH agonists, triptorelin causes an initial transient increase in testosterone levels and may initiate or worsen symptoms during this transient period. Rare post-marketing reports of anaphylactic shock and angioedema have been reported. TRELSTAR(R) is contraindicated for use in women who are or may become pregnant. For additional information, please discuss with your physician or contact Watson Medical Communications at 866-75-J3315.
About Prostate Cancer
Prostate cancer is the most common cancer in men in the U.S., excluding skin cancer, and is estimated to account for 25 percent of all new cancers diagnosed in men. According to the American Cancer Society, approximately 186,320 new cases of prostate cancer are expected to be diagnosed in 2008 in the U.S.; 28,660 men with prostate cancer are expected to die this year(1). The majority of cases diagnosed are in men over the age of 65. Prostate cancer can be detected early through regular digital rectal examinations and PSA testing. Low PSA levels typically are found in the blood of healthy men; the amount of PSA in the blood normally increases in the presence of prostate cancer.
Source: Watson Pharmaceuticals