Data on Nadir Testosterone Levels Achieved by ELIGARD® (leuprolide acetate) for injectable suspension published in Reviews in Urology
CHICAGO, July 24, 2019 (GLOBE NEWSWIRE) -- Tolmar Pharmaceuticals, Inc. today announced the publication of a study of nadir testosterone (T) levels achieved in pivotal trials for ELIGARD® (leuprolide acetate) for injectable suspension. The study, published in Reviews in Urology, was the first to evaluate nadir serum T in patients treated with a luteinizing hormone-releasing hormone (LHRH) agonist, in this case subcutaneous leuprolide acetate. Nadir serum testosterone, or “nadir T,” is the lowest value of testosterone achieved during androgen deprivation therapy, and evidence is accumulating for nadir T levels around advanced prostate cancer treatments.
Testosterone suppression through androgen deprivation therapy (ADT) is the standard of care in management of advanced prostate cancer, as the treatment deprives tumor cells of the fuel they require to thrive. LHRH agonists are the most commonly used drugs for ADT and are foundational throughout the course of a patient’s advanced prostate cancer treatment.
The study reviewed four prospective, open-label, fixed-dose clinical trials of ELIGARD in patients with advanced prostate cancer and no prior use of ADT. While data on nadir T levels have been reported with some therapies, this is the first data published on nadir T levels achieved with LHRH agonist monotherapy.
“This study reflects Tolmar’s ongoing commitment to increased understanding of ADT therapy across the continuum of advanced prostate cancer care through research and peer-reviewed publications,” said Stuart Atkinson, MB ChB, Vice President Medical Affairs, Tolmar Pharmaceuticals, Inc.
About TOLMAR and ELIGARD
TOLMAR is a fully integrated pharmaceutical company focused on the innovative development, approval, manufacturing and commercialization of specialty pharmaceuticals. The Company's lead product, ELIGARD®, is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer.
"TOLMAR" refers to TOLMAR Holding, Inc. and its wholly owned operating subsidiaries, TOLMAR Inc., TOLMAR Therapeutics, Inc., and TOLMAR Pharmaceuticals, Inc. ELIGARD was developed and is manufactured by TOLMAR Inc. TOLMAR global headquarters, product development and manufacturing facilities are based in northern Colorado, while TOLMAR Pharmaceuticals' U.S. commercial business is based in Lincolnshire, Illinois. For more information about the company, please visit www.tolmar.com. Information about ELIGARD is available at www.eligard.com
For more information: http://medreviews.com/journal/reviews-in-urology/vol/20/no/2/effectiveness-subcutaneously-administered-leuprolide-acetate-achieve-low-nadir-testosterone-in-prostate-cancer-patients
Important Safety Information for ELIGARD® (leuprolide acetate) for injectable suspension
ELIGARD® is indicated for the palliative treatment of advanced prostate cancer.
ELIGARD is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs, or any of the components of ELIGARD. Anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have been reported in the literature. Transient increase in serum levels of testosterone during treatment may result in worsening of symptoms or onset of new signs and symptoms during the first few weeks of treatment, including bone pain, neuropathy, hematuria, bladder outlet obstruction, ureteral obstruction, or spinal cord compression.
Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH analogs. Monitor blood glucose level and manage according to current clinical practice. Increased risk of myocardial infarction, sudden cardiac death and stroke has also been reported with use of GnRH analogs in men. Monitor for cardiovascular disease and manage according to current clinical practice. Androgen deprivation therapy may prolong the QT/QTc interval. Consider risks and benefits. May cause fetal harm. Convulsions have been observed in patients taking leuprolide acetate with or without a history of predisposing factors. Manage convulsions according to the current clinical practice.
ELIGARD may impair fertility in males of reproductive potential.
The most common injection site adverse events are transient burning and stinging, pain, bruising, and erythema. The most common systemic adverse events include mild to severe hot flashes/sweats, malaise and fatigue, weakness, myalgia, dizziness, clamminess, testicular atrophy, and gynecomastia. As with other GnRH agonists, other adverse reactions, including decreased bone density and rare cases of pituitary apoplexy have been reported. See package insert for full prescribing and safety information.
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