JATENZO is the first and only FDA-approved oral testosterone replacement therapy of its kind
Coverage effective December 1, 2020 on the Express Scripts National Preferred, Basic and High Performance Formularies
NORTHBROOK, Ill., Dec. 07, 2020 (GLOBE NEWSWIRE) — Clarus Therapeutics, Inc. today announced that Express Scripts, Inc, one of the leading pharmacy benefit managers (PBMs) in the United States will now cover JATENZO® (testosterone undecanoate) capsules, CIII. JATENZO is the first and only FDA-approved oral testosterone undecanoate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).1,2 Important Safety Information, including Boxed Warning, is provided below. Limitations of use: Safety and efficacy of JATENZO in males less than 18 years old have not been established.
“This partnership with Express Scripts meaningfully enhances the coverage of JATENZO for patients, and provides appropriate hypogonadal men additional access to an oral testosterone replacement therapy option,” said Dr. Robert Dudley, Chief Executive Officer of Clarus Therapeutics, Inc. “We believe this improved access to JATENZO will give physicians, and their appropriate patients, a convenient oral option for testosterone replacement therapy, and an alternative, not only for new patients, but for those patients who are dissatisfied with their current treatment options.”
As of December 1, 2020, nearly 99 million commercial lives, or 61.4% of lives in the U.S., now have access to JATENZO with the addition of Express Scripts. Clarus is committed to working with payers to further broaden JATENZO access for patients and to support patients and providers who desire an oral testosterone replacement therapy option. Clarus also offers patients financial assistance through its JATENZO GO program, where eligible patients with commercial insurance may pay as little as $0 for their monthly prescription of JATENZO. For eligible patients with commercial coverage for JATENZO, their first prescription is free while waiting for insurance verification and prior authorization appeals. Patients can find out more by calling 1-844-269-2795 or visiting the JATENZO website at www.Jatenzo.com for all eligibility requirements.
About Hypogonadism
Hypogonadism is a clinical syndrome that results from a failure of the testes to produce physiological concentrations of testosterone.3 According to current clinical guidelines from the Endocrine Society and the American Urological Association, diagnosis of hypogonadism is determined by both the identification of symptoms and/or signs consistent with the condition, and measurement of low morning total serum testosterone concentration, defined as <300 ng/dL, on 2 separate days.3,4
About JATENZO
JATENZO is the first and only FDA-approved oral testosterone undecanoate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).1,2
JATENZO’s proprietary formulation is built around testosterone undecanoate—a testosterone prodrug that the body converts to testosterone.1 In the JATENZO pivotal inTUne (investigational testosterone undecanoate) clinical trial, 87 percent of hypogonadal men treated with JATENZO achieved a mean total testosterone concentration in the eugonadal range at the end of treatment.1 The efficacy and safety of JATENZO was evaluated in 166 adult, hypogonadal males in a 4-month, open-label study. The primary endpoint was the percentage of patients with mean plasma total testosterone concentration (Cavg) over 24 hours within the normal eugonadal range on the final PK visit of the study.1
About Clarus Therapeutics, Inc.
Clarus is a men’s specialty pharmaceutical company developing and commercializing JATENZO, a product protected by patents issued in the United States and in other major pharmaceutical markets around the world. Clarus owns the worldwide, royalty-free commercialization rights for JATENZO. For more information, please visit: www.clarustherapeutics.com.
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:
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
CONTRAINDICATIONS
JATENZO is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate, in women who are pregnant, in men with a known hypersensitivity to JATENZO or its ingredients, or in men with hypogonadal conditions that are not associated with structural or genetic etiologies as JATENZO has not been established for these conditions and there is a risk of increased blood pressure with JATENZO that can increase the risk of MACE.
WARNINGS AND PRECAUTIONS
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%).
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
The safety and efficacy of JATENZO in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses.
There have not been sufficient numbers of geriatric patients involved in controlled clinical studies utilizing JATENZO to determine whether efficacy or safety in those over 65 years of age differs from younger subjects. There is insufficient long-term safety data in geriatric patients utilizing JATENZO to assess the potentially increased risk of cardiovascular disease and prostate cancer.
Please click here for full Prescribing Information, including BOXED WARNING on increases in blood pressure.
Media Contact
Rozita Passarella
Vice President, Marketing
Clarus Therapeutics, Inc.
Email: RPassarella@clarustherapeutics.com
Phone: 847.562.4300 (ext 204)
____________________________________________
1JATENZO (testosterone undecanoate) [prescribing information]. Clarus Therapeutics, Inc.
2US Food & Drug Administration. FDA Approved Drug Products. Available at: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206089. Accessed October 1, 2019.
3Bhasin S, et al. J Clin Endocrinol Metab. 2018;103(5):1715-1744.
4Mulhall JP, et al. J Urol. 2018;200(2):423-432.
© 2020 Clarus Therapeutics, Inc. All rights reserved.
CLA-US-0006 11/2020
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