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Acerus Announces Publication of Study Results Demonstrating Effectiveness of NATESTO® Regardless of Baseline Symptom Severity
“Acerus continues to achieve important scientific milestones related to the global evolution of NATESTO®. With the publication of the study entitled Efficacy of Nasal Testosterone Gel (NATESTO®) Stratified by Baseline Endogenous Testosterone Levels, 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.
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. Patient data from the phase 3 study was classified based on the degree of testosterone deficiency demonstrated by patients at study entry. 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. 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. 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. 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.
“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. “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. 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
“Acerus continues to achieve important scientific milestones related to the global evolution of NATESTO®. With the publication of the study entitled Efficacy of Nasal Testosterone Gel (NATESTO®) Stratified by Baseline Endogenous Testosterone Levels, 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.
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. Patient data from the phase 3 study was classified based on the degree of testosterone deficiency demonstrated by patients at study entry. 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. 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. 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. 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.
“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. “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. 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
