Margaux Guidry*1, Gerwin Westfield1, Alan D Rogol2 and Nathan Bryson3
1Aytu BioScience 2University of Virginia, Charlottesville, VA, 3Acerus Pharmaceuticals, Mississauga, ON, Canada

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Margaux Guidry*1, Gerwin Westfield1, Alan D Rogol2 and Nathan Bryson3
1Aytu BioScience 2University of Virginia, Charlottesville, VA, 3Acerus Pharmaceuticals, Mississauga, ON, Canada

The safety of testosterone therapy (TTh) remains a primary concern when treating men with hypogonadism. Adverse effects of TTh include an increase in hemoglobin and hematocrit, or secondary polycythemia. These increases are as high as 3.5 fold1. If unmanaged, polycythemia could lead to jaundice, pruritus, cerebrovascular accidents, thrombosis, or bleeding2. The thrombotic risks of TTh have become much more of a concern following the release of a new label warning by the FDA in 20143. Patients taking Natesto throughout a one-year safety trial had no meaningful differences in hematologic abnormalities. Natesto is a bio-adhesive testosterone gel for intranasal application that is readily absorbed and rapidly elevates serum T levels as soon as the first applied dose (Avg. baseline 210.4 ng/dL; Avg. Cmax 818.49 ng/dL reached in 40 mins). The safety of Natesto was evaluated in hypogonadal men during a 90-day treatment period in which subjects received an 11 mg dose twice daily (BID, n=120), or three times daily (TID, n=152). A 90-day, open-label, safety extension period for study participants; and an additional 180-day, open-label safety extension period for a subset of 75 subjects. The total duration of study participation for subjects completing all 4 periods was up to 406 days (~58 weeks), depending upon the washout period. There were no meaningful differences in hematologic abnormalities among treatment groups. The mean baseline hematocrit value for the BID and TID groups were 44.8% and 44.7%, respectively. At Day 90, both showed a slight decrease (43.5% and 44.6%, respectively) that can be attributed to blood withdrawal for the PK study. At Day 180 and Day 360, the mean hematocrit values were (45.1% and 45.9%) and (45.5% and 45.2%), respectively. Hematocrit values did not exceed the ULN during treatment in the majority of subjects. A fairly low percentage of subjects overall had either hematocrit or hemoglobin above the upper limit of the normal range. 8 subjects had hematocrit values >54% during the study (after baseline/screening): 3 (2.1%) subjects in the BID group, and 5 (3.0%) subjects in the combined TID group. No hematocrit and hemoglobin value above the normal range was clinically significant. No post-treatment hematocrit value was above 58%. No subjects discontinued the study due to hematologic abnormalities. In conclusion, Natesto permits men to achieve serum total T levels in the normal range while not increasing in hematologic values above the normal range, therefore Natesto is a safe option for patients treated with hypogonadism.

Disclosure: MG: Employee, Aytu BioScience. GW: Employee, Aytu Bio. ADR: Consultant, Aytu BioScience. NB: Employee, Acerus Pharmaceuticals.

Please take note of the Endocrine Society's News Embargo Policy at: https://www.endocrine.org/news-room/endo-annual-meeting

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