Natesto ”MY-T study” – First Study to Demonstrate Improvement of Low T Symptoms in Men After Switching to Natesto from Topical Testosterone Gels
ENGLEWOOD, CO / ACCESSWIRE / March 19, 2019 / Aytu BioScience, Inc. (NASDAQ: AYTU), a specialty pharmaceutical company focused on global commercialization of novel products addressing significant medical needs, announced two recent publications summarizing findings from the Phase 4, Natesto® ”MY-T study.” The MY-T study is the first clinical trial documenting that patients’ hypogonadal symptoms improved after switching to Natesto from a topical testosterone gel. Further, the results confirmed the majority of patients prefer Natesto over topical testosterone gels and had higher levels of treatment satisfaction.
The MY-T study was a prospective, multi-centered, open-label study investigating symptom improvement and patient satisfaction with Natesto treatment in subjects that have previously been on topical testosterone therapy, and those that were naïve to testosterone treatment. The original articles are entitled, ”MY-T study: Symptom-based titration decisions when using testosterone nasal gel, Natesto®” and ”The MY-T study: Patient satisfaction and preference.”
The two manuscripts were recently e-published ahead of print in the Canadian Urologic Association Journal, and the lead author is Jay Lee, MD, Department of Surgery, Division of Urology, University of Calgary.
This clinical trial is the first to document patient preference of hypogonadal men previously treated with topical testosterone gel (for at least three months), before being switched to the Natesto intranasal application. Twenty-four testosterone-naïve and 93 testosterone-experienced hypogonadal men (total n = 117) were treated with Natesto for either 90 or 120 days. Hypogonadal symptoms were improved by 15% (p < 0.0001) through 90 days of Natesto treatment for all treatment groups.
The testosterone-experienced men were given a treatment satisfaction questionnaire immediately prior to ending their topical testosterone gel treatment, and then subsequently upon switching to Natesto. Within 30 days of beginning Natesto treatment (and continuing through the full treatment period), there was a 20% increase in how ”effective” the subject felt Natesto was compared to the topical gel. Additionally, there was a 30% increase in how ”convenient” the subject felt Natesto was compared to the previously used topical gel.
Overall, 67.2% of Natesto-treated men agreed or strongly agreed that they preferred Natesto over topical testosterone gel. Further, the testosterone experienced subjects reported ease of use, convenience, efficacy/effectiveness, and travel friendliness as primary ”likes” of the Natesto therapy.
The MY-T study’s authors concluded, ”For patients switching from a topical medication to [Natesto] testosterone nasal gel (TNG), effectiveness, convenience and symptoms all demonstrated significant improvements indicating that the divided dose, ultradian profile with TNG is at least, and possibly more, efficacious than the steady state profile provided by topical testosterone. When followed-up 30 days post-treatment, the majority of patients in this study reported having made the switch to TNG as their preferred choice of medication for testosterone replacement.”
Links to the two MY-T study online publications can be found below:
The MY-T study was supported by Acerus Pharmaceuticals.
Aytu BioScience is supporting an investigator-initiated trial studying Natesto’s effects on serum testosterone levels, gonadotropin levels, and semen parameters to assess Natesto’s ability to increase testosterone levels while preserving male fertility parameters.
Complete details on the study can be found at https://clinicaltrials.gov/ct2/show/NCT03203681?term=Natesto&rank=4
About Aytu BioScience, Inc.
Aytu BioScience is a commercial-stage specialty pharmaceutical company focused on global commercialization of novel products addressing significant medical needs. The company currently markets Natesto®, the only FDA-approved nasal formulation of testosterone for men with hypogonadism (low testosterone, or “Low T”). Aytu also has exclusive U.S. and Canadian rights to ZolpiMist™, an FDA-approved, commercial-stage prescription sleep aid indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Aytu recently acquired exclusive U.S. commercial rights to Tuzistra® XR, the only FDA-approved 12-hour codeine-based antitussive. Tuzistra XR is a prescription antitussive consisting of codeine polistirex and chlorpheniramine polistirex in an extended-release oral suspension. Additionally, Aytu is developing MiOXSYS®, a novel, rapid semen analysis system with the potential to become a standard of care for the diagnosis and management of male infertility caused by oxidative stress. MiOXSYS is commercialized outside of the U.S. where it is a CE Marked, Health Canada cleared, Australian TGA approved, Mexican COFEPRAS approved product, and Aytu is planning U.S.-based clinical trials in pursuit of 510k de novo medical device clearance by the FDA. Aytu’s strategy is to continue building its portfolio of revenue-generating products, leveraging its focused commercial team and expertise to build leading brands within large, growing markets. For more information visit aytubio.com.
This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. All statements other than statements of historical facts contained in this presentation, are forward-looking statements. Forward looking statements are generally written in the future tense and/or are preceded by words such as ”may,” ”will,” ”should,” ”forecast,” ”could,” ”expect,” ”suggest,” ”believe,” ”estimate,” ”continue,” ”anticipate,” ”intend,” ”plan,” or similar words, or the negatives of such terms or other variations on such terms or comparable terminology. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: risks relating to the completion and final results of various clinical studies, gaining market acceptance of our products, obtaining reimbursement by third-party payors, the potential future commercialization of our product candidates, the anticipated start dates, durations and completion dates, as well as the potential future results, of our ongoing and future clinical trials, the anticipated designs of our future clinical trials, anticipated future regulatory submissions and events, our anticipated future cash position and future events under our current and potential future collaboration. We also refer you to the risks described in ”Risk Factors” in Part I, Item 1A of the Company’s Annual Report on Form 10-K and in the other reports and documents we file with the Securities and Exchange Commission from time to time.
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