OBJECTIVES

: To evaluate the usability of abaloparatide solid microstructured transdermal system (ABL-sMTS) as measured by overall persistence, satisfaction, and acceptability of study therapy.

METHODS

: A total of 22 healthy, postmenopausal (PMP) women, aged 50-85y, with BMD T-score < -1.0 and >-5.0 at the lumbar spine or hip were treated in this single-arm open-label study. Subjects were trained to self-administer the ABL-sMTS once daily to their anterior thigh for 5 minutes, alternating sides, for a period of 29 days. ABL-sMTS usability was measured by user error incidence, satisfaction, and acceptability, by subject diary as well as total used ABL-sMTS returned at each study visit. Treatment satisfaction was measured with the psychometrically validated Treatment Satisfaction Questionnaire for Medication short form (TSQM-9) Global Satisfaction and Convenience domains. The TSQM-9 domain scores were calculated according to the User Manual (Version 1.1, October 2018) with higher scores representing higher satisfaction for each domain. Acceptability was measured using a 5-point Likert scale (1=least acceptable/negative; 5=most acceptable/positive).

RESULTS

: All 22 PMP women completed the study. Mean age was 65.2y, mean T-score was -1.32 at the total hip and -1.98 at the lumbar spine. The success rate for self-administration at first application over 29 days was 99.7%. ABL-sMTS adhesion scores were ≥90% throughout the study; none detached prior to completion of the 5-minute wear time. Subjects were satisfied with ABL-sMTS with mean TSQM Global Satisfaction and Convenience scores on day 15 being 64.29 (range 21.4-92.9) and 74.49 (range 38.9-100.0 ) respectively. Overall acceptability was high with the mean acceptability of 4.5.

CONCLUSIONS

: This is the first evaluation of a novel transdermal, self-administered, multi-dose regimen of ABL-sMTS in PMP women with low BMD. Subjects had no difficulty with daily self-administration of ABL-sMTS. Overall satisfaction, convenience and acceptability were high, supporting continued clinical development of ABL-sMTS.