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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
Acerus Announces Publication of Study Results Demonstrating Effectiveness of NATESTO® Regardless of Baseline Symptom Severity
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<blockquote data-quote="madman" data-source="post: 153673" data-attributes="member: 13851"><p><a href="https://www.businesswire.com/news/home/20190708005166/en/" target="_blank">Acerus Announces Publication of Study Results Demonstrating Effectiveness of NATESTO® Regardless of Baseline Symptom Severity</a> </p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p><strong>“Acerus continues to achieve important scientific milestones related to the global evolution of NATESTO®. With the publication of the study entitled <em>Efficacy of Nasal Testosterone Gel (NATESTO®) Stratified by Baseline Endogenous Testosterone Levels</em>, we now have evidence that the product is effective in patients regardless of the degree of their baseline hypogonadism,” said Ed Gudaitis, President and Chief Executive Officer of Acerus Pharmaceuticals. </strong></p><p></p><p></p><p><strong><span style="color: rgb(184, 49, 47)">This new scientific report describes a post-hoc analysis of data from the pivotal Phase 3 study of NATESTO®, which enrolled 306 patients from 52 sites in the United States, who were treated with NATESTO® for up to 1 year. </span>Patient data from the phase 3 study was classified based on the degree of testosterone deficiency demonstrated by patients at study entry. <span style="color: rgb(44, 130, 201)">Each dose of NATESTO® resulted in a short-term return of testosterone to the upper normal range (800 ng/dL; 28 nmol/L) irrespective of how low the patient’s baseline testosterone was prior to the study. </span><span style="color: rgb(26, 188, 156)">In the patient group with the lowest baseline testosterone level, a mean average serum testosterone level of 295 ng/dL (10.2 ng/dL) was achieved with NATESTO® exposure. As well, statistically significant improvements in symptom relief (erectile function, mood and lean body mass) were observed in these patients. </span><span style="color: rgb(251, 160, 38)">In between NATESTO® doses, all patients in the phase 3 study maintained their natural testosterone at the same levels they had prior to entry into the study, indicating that NATESTO® does not suppress natural testosterone production. </span><span style="color: rgb(44, 130, 201)">Based on the data, Acerus believes that the mechanism of action of NATESTO® is unique whereby the peaks in testosterone generated by NATESTO® dosing provide efficacy and improvement of symptoms, while the time between doses (4-8 hours) allows for the maintenance of testicular testosterone production and sperm production.</span></strong></p><p></p><p></p><p><strong><span style="color: rgb(184, 49, 47)">“The pharmacology of NATESTO® is unique from other testosterone products that treat low testosterone or hypogonadism”, said Dr. Ethan Grober, Associate Professor, Division of Urology, University of Toronto and one of the new study’s authors.</span> <span style="color: rgb(44, 130, 201)">“The release of testosterone with NATESTO® is pulsatile - closely matching the bodies "natural" testosterone release. Consequently, NATESTO® does not suppress a man's natural testosterone level, but simply adds to it to achieve a normal, safe level of testosterone. </span>Furthermore, NATESTO® has been shown to work even in severely testosterone deficient patients, suggesting that a wide range of testosterone deficient patients can be effectively treated </strong></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p></blockquote><p></p>
[QUOTE="madman, post: 153673, member: 13851"] [URL="https://www.businesswire.com/news/home/20190708005166/en/"]Acerus Announces Publication of Study Results Demonstrating Effectiveness of NATESTO® Regardless of Baseline Symptom Severity[/URL] [B]“Acerus continues to achieve important scientific milestones related to the global evolution of NATESTO®. With the publication of the study entitled [I]Efficacy of Nasal Testosterone Gel (NATESTO®) Stratified by Baseline Endogenous Testosterone Levels[/I], we now have evidence that the product is effective in patients regardless of the degree of their baseline hypogonadism,” said Ed Gudaitis, President and Chief Executive Officer of Acerus Pharmaceuticals. [/B] [B][COLOR=rgb(184, 49, 47)]This new scientific report describes a post-hoc analysis of data from the pivotal Phase 3 study of NATESTO®, which enrolled 306 patients from 52 sites in the United States, who were treated with NATESTO® for up to 1 year. [/COLOR]Patient data from the phase 3 study was classified based on the degree of testosterone deficiency demonstrated by patients at study entry. [COLOR=rgb(44, 130, 201)]Each dose of NATESTO® resulted in a short-term return of testosterone to the upper normal range (800 ng/dL; 28 nmol/L) irrespective of how low the patient’s baseline testosterone was prior to the study. [/COLOR][COLOR=rgb(26, 188, 156)]In the patient group with the lowest baseline testosterone level, a mean average serum testosterone level of 295 ng/dL (10.2 ng/dL) was achieved with NATESTO® exposure. As well, statistically significant improvements in symptom relief (erectile function, mood and lean body mass) were observed in these patients. [/COLOR][COLOR=rgb(251, 160, 38)]In between NATESTO® doses, all patients in the phase 3 study maintained their natural testosterone at the same levels they had prior to entry into the study, indicating that NATESTO® does not suppress natural testosterone production. [/COLOR][COLOR=rgb(44, 130, 201)]Based on the data, Acerus believes that the mechanism of action of NATESTO® is unique whereby the peaks in testosterone generated by NATESTO® dosing provide efficacy and improvement of symptoms, while the time between doses (4-8 hours) allows for the maintenance of testicular testosterone production and sperm production.[/COLOR][/B] [B][COLOR=rgb(184, 49, 47)]“The pharmacology of NATESTO® is unique from other testosterone products that treat low testosterone or hypogonadism”, said Dr. Ethan Grober, Associate Professor, Division of Urology, University of Toronto and one of the new study’s authors.[/COLOR] [COLOR=rgb(44, 130, 201)]“The release of testosterone with NATESTO® is pulsatile - closely matching the bodies "natural" testosterone release. Consequently, NATESTO® does not suppress a man's natural testosterone level, but simply adds to it to achieve a normal, safe level of testosterone. [/COLOR]Furthermore, NATESTO® has been shown to work even in severely testosterone deficient patients, suggesting that a wide range of testosterone deficient patients can be effectively treated [/B] [B][COLOR=rgb(44, 130, 201)] [/COLOR][/B] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
Acerus Announces Publication of Study Results Demonstrating Effectiveness of NATESTO® Regardless of Baseline Symptom Severity
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