Tolmar Publishes Study in the February Issue of Journal of Urology on the Impact of Late Dosing on Testosterone Suppression with Two Different Leuprolide Acetate Formulations: In Situ Gel and Microsphere - An Analysis of US Clinical Data

BUFFALO GROVE, Ill., April 12, 2021 /PRNewswire/ -- Tolmar Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, announced the publication of a manuscript entitled "Impact of Late Dosing on Testosterone Suppression with Two Different Leuprolide Acetate Formulations: In Situ Gel and Microsphere – An Analysis of US Clinical Data" in the February issue of Journal of Urology.

This retrospective analysis of real-world data is a more detailed follow-up of the results to "The Impact of Late Luteinizing Hormone-Releasing Hormone Agonist Dosing on Testosterone Suppression in Patients with Prostate Cancer: An Analysis of United States Clinical Data," which was published in the April 2020 issue of Journal of Urology. Leuprolide acetate is the most commonly used drug for androgen deprivation therapy (ADT) in men with advanced prostate cancer. The article reported the impact on testosterone suppression of late dosing of GnRH agonists in general.

Androgen deprivation therapy (ADT) is the standard of care for the treatment of advanced prostate cancer. It aims to reduce circulating testosterone (T) to castration levels in order to remove the 'fuel' that simulates cancer cells to grow. The goal is to reduce testosterone (T) to <50ng/dl, however there is a strong body of evidence recommending <20ng/dl as the benchmark.

"This new study reflects Tolmar's ongoing commitment to furthering research on the treatment of advanced prostate cancer through peer-reviewed publications," said David Crawford, M.D., Clinical Professor of Urology, University of California San Diego

This study was supported by Tolmar Pharmaceuticals, Inc. For more information, please click here

About Tolmar and ELIGARD

Tolmar is a fully integrated pharmaceutical company focused on the technology-driven development, approval, manufacturing, and commercialization of specialty pharmaceuticals. The Company's lead product, ELIGARD®, is a luteinizing hormone releasing hormone (LHRH) 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 Buffalo Grove, Illinois. For more information about the company, please visit www.TOLMAR.com. Information about ELIGARD is available at www.eligard.com.

IMPORTANT SAFETY INFORMATION

ELIGARD (leuprolide acetate for injectable suspension) is a medicine for the treatment of advanced prostate cancer. It works by reducing the amount of testosterone in the blood. It is not a cure.

ELIGARD should not be used by anyone who is allergic to any of the ingredients in ELIGARD or to any medicines that reduce testosterone the same way. ELIGARD should not be used by women who are pregnant or may become pregnant. ELIGARD can cause pregnancy loss or harm to an unborn baby if used in pregnant women.

Severe and possibly life-threatening reactions called anaphylaxis have occurred in people receiving ELIGARD.

Increased risk of heart attack, sudden death due to heart problems and stroke have also been reported in men taking ELIGARD. ELIGARD may also affect electrical activity in the heart that can cause an irregular heartbeat. Your doctor will monitor you for heart conditions.

Elevated blood sugar and an increased risk of developing diabetes have been reported in men receiving ELIGARD. Your doctor will monitor blood sugar levels.

ELIGARD causes an increase in testosterone during the first few weeks of therapy and some men may experience new or worsening symptoms of prostate cancer e.g., bone pain, urinary symptoms, or nerve problems such as numbness, during this period. If your cancer has spread to the urinary tract or spine, urinary blockage or pressure on the spine that can lead to paralysis may occur. Your doctor will discuss with you the benefits and risks of taking ELIGARD.

The most common injection site reactions are transient burning and stinging, pain, bruising, and redness. The most common side effects include hot flashes/sweats, fatigue, weakness, muscle pain, dizziness, clamminess, testicular shrinkage, decreased erections and enlargement of breasts. Other side effects, including thinning of bones that may lead to fracture, and rare but serious problems with the pituitary gland in the brain, have been reported with ELIGARD.

Please see Full Prescribing Information for additional important safety information.

Media Contact Information:

Julie Ferguson
[email protected]
(312) 385-0098

SOURCE Tolmar Pharmaceuticals, Inc.