NORTHBROOK, Ill., Dec. 11, 2019 (GLOBE NEWSWIRE) -- Clarus Therapeutics, Inc. today announced the appointment of five senior leaders, each of whom bring valuable industry and category experience to the team. Together they strengthen the companys commercialization capability for JATENZO (testosterone undecanoate) capsules, the first-in-class oral testosterone replacement therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of hypogonadism. See indication and important risk information, including boxed warning below.
Dr. Newmark, Mr. Jaeger, Mr. Rodriguez, Ms. Wright and Mr. Holloway join a management team led by Robert Dudley, Ph.D., Clarus Therapeutics Chief Executive Officer and co-inventor of JATENZO. Dr. Dudleys legacy in mens health includes CEO leadership of the company that developed and launched AndroGel, a product he co-invented and the last major advancement in testosterone replacement therapy delivery.
We are proud to bring Jay, Frank, Jose, LaTonya, and James into an organization that shares their focus on innovation and excellence. They have each demonstrated an ability to connect with medical professionals who are invested in mens health, said Dudley. Their expertise will help us make the long sought-after oral testosterone option widely available to appropriate hypogonadal men.
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
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
The most common adverse events of JATENZO (incidence 2%) are headache (5%), increased hematocrit (5%), hypertension (4%), decreased HDL (3%), and nausea (2%).
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 see accompanying full Prescribing Information, including BOXED WARNING on increases in blood pressure.About JATENZO JATENZO is a first-in-class proprietary oral soft gel formulation of testosterone undecanoate for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
JATENZOs proprietary formulation is built around testosterone undecanoate a testosterone prodrug that the body converts to testosterone. In the JATENZO pivotal inTUne (investigation of its oralTestosteroneUndecanoate) clinical trial, 87% (n=222) of men treated with JATENZO achieved average circulating levels of testosterone in the normal range for men.
About Clarus Therapeutics, Inc.Clarus is a men's specialty pharmaceutical company developing and preparing for the commercial launch of 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.
Media ContactAmir KhanPhone: (212) 462-8767Email: Amir.Khan@Syneoshealth.com
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