Tolmar Announces Results From Inaugural Landmark Survey of US Physicians To Assess Current State of Testosterone Replacement Therapy (TRT) and the Impact on Practices and Patient Care

Results of survey will be presented by Adrian Dobs, M.D., Professor of Medicine and Oncology, The Johns Hopkins School of Medicine, and Sandeep Dhindsa, M.B.B.S., Director of Division of Endocrinology, Diabetes and Metabolism, St. Louis University School of Medicine, at ENDO 2024 in Boston on June 2.

BUFFALO GROVE, Ill., June 2, 2024 /PRNewswire/ — Tolmar Inc., a fully integrated pharmaceutical company, today announced results from a landmark survey of more than 300 US physicians, revealing barriers to treatment with testosterone-replacement therapy (TRT) among patients and physicians that, if addressed, may improve patient care. Detailed results of the survey will be presented at ENDO 2024, the signature annual meeting in endocrinology, in Boston on Sunday, June 2. The survey was conducted in partnership with the leading online physician community, Sermo.

“Men living with a testosterone deficiency have more treatment options than ever, but this expanded range of choices can be confusing. A key finding in the survey is that 66% of men on TRT switched therapy in the last year in order to find a form of therapy that works best for them. Not surprisingly, much of this is driven by insurance, but there is also a lack of awareness of newer and safe treatment options, like oral therapy, that may improve patient care,” said Sandeep Dhindsa, M.B.B.S., Director of Division of Endocrinology, Diabetes and Metabolism, St. Louis University School of Medicine.

Uncovering Insights Into the Current TRT Landscape
Results from the survey showed challenges and potential solutions to effectively treat men with low or no testosterone. More than one-quarter of patients do not take their TRT as prescribed, according to physicians surveyed. For 71% of patients, oral medication is the preferred choice, but only 22% percent are aware of them. Lastly, half of physicians (50%) are unaware of current oral TRT and its proven safety profile.  

“This reinforces the need for continued education on TRT and the importance of working closely with patients on a treatment plan. With a better understanding of safe and effective TRT options, we can improve adherence, minimize the need to switch treatments and help patients get the care they deserve,” said Adrian Dobs, M.D., Professor of Medicine and Oncology, The Johns Hopkins School of Medicine.

To explore the data driving these insights, visit www.JatenzoHCP.com to download the presentation of results and findings. 

About the Survey
In February 2024, Sermo conducted a survey of 303 physicians, including endocrinologists, urologists, primary care physicians and others experienced in prescribing testosterone-replacement therapy (TRT). The objectives of the survey were to: 1) understand the TRT patient experience and unmet needs; 2) outline prescribing behaviors and barriers across multiple specialties; and 3) uncover barriers to treatment and opportunities for patient and peer education. 

About Tolmar Inc.
Tolmar is a fully integrated pharmaceutical company focused on the development, manufacturing, and commercialization of specialty pharmaceuticals across multiple therapeutic areas, including Endocrinology. Tolmar’s product development and manufacturing facilities are based in Northern Colorado and its executive offices and commercial headquarters are based in Buffalo Grove, Illinois. For more information about the company, please visit www.tolmar.com. 

About Sermo
Sermo is the largest global healthcare research company and the most trusted physician and provider engagement platform. Sermo engages with more than 1.5 million HCPs across 150 countries and has reach into the U.S. Payer market that now exceeds 230M commercial lives covered. For over 20 years, Sermo has been turning physician experience, expertise, and observations into actionable business insights that benefit pharmaceutical companies, healthcare partners, and the medical community at large. Sermo offers on-demand access to HCPs via a proprietary health-tech ecosystem to gain targeted HCP insights that inform strategic decisioning in real-time. To learn more, visit www.sermo.com. 

About JATENZO® 

Indication 

JATENZO® (testosterone undecanoate) capsules, CIII, is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: 

Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range. 

Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations but have gonadotropins in the normal or low range. 

Limitation of use
Safety and efficacy of JATENZO in males less than 18 years old have not been established. 

IMPORTANT SAFETY INFORMATION 

WARNING: INCREASES IN BLOOD PRESSURE

JATENZO can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death. 

Before initiating JATENZO, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled. 

Periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension and re-evaluate whether the benefits of JATENZO outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment. 

Due to this risk, use JATENZO only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies. 

CONTRAINDICATIONS 

JATENZO is contraindicated in men with breast cancer or known or suspected prostate cancer. JATENZO is contraindicated in women who are pregnant as testosterone may cause fetal harm. 

WARNINGS AND PRECAUTIONS 

Check hematocrit prior to initiation and every 3 months while a patient is on JATENZO and if hematocrit becomes elevated, stop JATENZO until hematocrit decreases to an acceptable level. 

If hematocrit increases after JATENZO is restarted, stop permanently. 

Monitor patients with benign prostatic hyperplasia (BPH) treated with androgens due to an increased risk for worsening signs and symptoms of BPH. 

Venous thromboembolic events (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), have been reported in patients using testosterone replacement products like JATENZO. Evaluate patients with signs or symptoms consistent with DVT or PE and, if a VTE is suspected, discontinue JATENZO and initiate appropriate workup and management. 

Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. 

Large doses of androgens can suppress spermatogenesis by feedback inhibition of pituitary FSH. Inform patients of this risk before prescribing JATENZO. Prolonged use of high doses of methyltestosterone has been associated with serious hepatic adverse events. JATENZO is not known to cause these adverse events; however, patients should be instructed to report any signs of hepatic dysfunction and JATENZO should be discontinued while the cause is evaluated. Edema, with or without congestive heart failure, may be a serious complication in patients with pre-existing cardiac, renal, or hepatic disease. In addition to discontinuation of the drug, diuretic therapy may be required. 

Gynecomastia may develop and persist in patients being treated for hypogonadism. 

Sleep apnea may occur in some patients, especially those with risk factors such as obesity or chronic lung disease. 

Changes in the serum lipid profile may require dose adjustment of lipid-lowering drugs or discontinuation of testosterone therapy. Monitor the lipid profile periodically, particularly after starting testosterone therapy. 

Use JATENZO with caution in cancer patients at risk of hypercalcemia. Monitor serum calcium concentration regularly during treatment with JATENZO in these patients. 

Androgens, including JATENZO, may decrease concentrations of thyroxine-binding globulin, resulting in decreased total T4 serum concentrations and increased resin uptake of T3 and T4. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. Depression and suicidal ideation have been reported in patients treated with JATENZO in clinical trials. 

ADVERSE EVENTS 

The most common adverse events of JATENZO (incidence ≥2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%). 

These are not all of the risks associated with JATENZO. For more information, click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure. 

Company Contact:
Steve Yuan
Steve.Yuan@tolmar.com
224.880.1616

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SOURCE Tolmar Inc.