Acerus Announces Canadian Commercial Launch of NATESTO
In a pivotal Phase III study, NATESTOTM demonstrated statistically significant improvements versus baseline in symptoms associated with hypogonadism, including sexual function and mood as soon as 30 days after initiating treatment. The Phase III findings are suggestive of an excellent safety profile and the product was well tolerated by patients.
NATESTOTM is self-administered via a pocket-sized,
travel-friendly nasal dispenser that facilitates rapid, on-the-go, TRT
dosing. This novel delivery system will enable men to take their therapy
in mere seconds, without worrying about the risks associated with
transference of testosterone to women or children. NATESTOTM
is also the lowest dose testosterone gel replacement therapy to be
approved in
“The availability of NATESTOTM in
Richard
Casey, Urologist and Director at
The prescription testosterone replacement market in
“This truly is a momentous event for Acerus,” said
Tom Rossi, President
and Chief Executive Officer of Acerus. “The commercial launch of NATESTOTM
in
About the NATESTOTM Phase III Study
NATESTOTM was evaluated in a multicentre, open-label, 90-day treatment period followed by two sequential safety extension periods of 90 and 180 days that enrolled 306 hypogonadal men, with a mean age of 54 years (range 28-80 years). During the initial treatment period (Days 1-30), 228 patients and 78 patients were treated with 22 mg and 33 mg of testosterone daily, respectively. On Day 45 of the trial, patients were maintained at the same dose or were titrated to three times a day, based on an assessment of 24-hour average serum testosterone concentration. At Day 90, the majority of patients had met the primary endpoint with an average serum total testosterone concentration within the normal range.
Secondary endpoints included assessments of sexual function and mood. Treatment with NATESTOTM produced significant improvements from baseline in erectile function, intercourse satisfaction, orgasmic function, sexual desire and overall satisfaction. In addition, the overall mean summary scores showed a significant increase in positive mood versus baseline.
The incidence of adverse events with NATESTOTM was low.
Prostate-specific antigen (
About NATESTO™ (Testosterone) Nasal Gel
NATESTOTM is approved and available in
NATESTOTM is also available in
About Acerus
Acerus markets ESTRACE® in
For more information, visit www.aceruspharma.com
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Notice regarding forward-looking statements:
Information in this press release that is not current or historical
factual information may constitute forward-looking information within
the meaning of securities laws. Implicit in this information are
assumptions regarding our future operational results. These assumptions,
although considered reasonable by the company at the time of
preparation, may prove to be incorrect. Readers are cautioned that
actual performance of the company is subject to a number of risks and
uncertainties, including with respect to NATESTOTM, and could
differ materially from what is currently expected as set out above. For
more exhaustive information on these risks and uncertainties you should
refer to our annual information form dated
References:
1. NATESTO™ Product Monograph,
2. Mulligan T, Frick MF, Zuraw QC, et al.
Prevalence of hypogonadism in males aged at least 45 years: The HIM
study. Int J Clin Pract 2006;60:762-769.
3. Bebb R. Testosterone
deficiency: Practical guidelines for diagnosis and treatment. BCMJ
2011:Vol. 53, No. 9.
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