Teva announces new efficacy, safety data from OLE study on Austedo tablets

Teva Pharmaceuticals announced new efficacy and safety data from a three-year open-label extension, or OLE, study on Austedo tablets in postmenopausal women with tardive dyskinesia, or TD. These data will be presented at the 2022 American Psychiatric Association, or APA, Annual Meeting, held May 21-25 in New Orleans and online June 7-10. In addition, new data assessing the psychological, social and physical impact of TD on patients and caregivers will also be featured in two posters at APA. In a post-hoc analysis of the long-term OLE study of Austedo, 137 women with TD who were postmenopausal were evaluated to determine the efficacy and safety of Austedo in this patient population. The analysis found Austedo provided improvements in TD-related movements in postmenopausal women. Mean change in total motor Abnormal Involuntary Movement Scale, or AIMS, score, a clinician-rated assessment tool, was -4.5 +/- 0.42 and -7.2 +/- 0.52 at Week 15 and Week 145, respectively. A majority of patients showed improvement across two patient outcome measures, Patient Global Impression of Change, or PGIC, and Clinical Global Impression of Change, or CGIC: For PGIC, 61% and 68% of patients showed improvement at Week 15 and Week 145, respectively. For CGIC, 63% and 82% of patients achieved "much improved" or "very improved" ratings at Week 15 and Week 145, respectively. Austedo safety findings were consistent with findings from the overall OLE study population, with no new safety concerns from long-term treatment. Poster: Long-Term Efficacy and Safety of Deutetrabenazine in Postmenopausal Women with Tardive Dyskinesia. The physical, psychological and social impact of TD was examined in two studies that assessed the burden and stigma of TD, regardless of the underlying condition, from the perspectives of both patients and caregivers in the U.S. Data were collected from a literature review and two online surveys conducted among 269 patients with TD and 162 caregivers. Impact was measured across different domains over the previous seven days in all categories. Findings demonstrate that TD has a significant psychological and social impact on patients and the patient experience can provide insight into stigma associated with TD. Over half of patients reported often/always feeling psychological impacts of TD, such as low self-esteem, fear of being rejected, being anxious/worried, being embarrassed, and being irritable/frustrated/angry. Caregivers rated low self-esteem, fear of being rejected, and being unable to focus as having a higher impact on patients. For social domains, 48.7%-55.8% of patients reported TD often/always impacted their ability to socialize with friends and join social activities, take public transportation, and appear on video, among other domains. Caregivers rated joining social activities, running errands and taking public transportation as having a higher social impact on patients. Over half of patients reported being bothered quite a bit/very much by reactions from spouses, children, classmates or colleagues. Over 90% of patients reported TD impacted physical functioning, with over two-thirds reporting moderate-to-severe impact on 15 of 24 impact measures, including: ability to fall asleep, ability to exercise and do household chores, ability to hold items such as glass or fork, worry about choking and feeling self-conscious about speech difficulties. Caregivers rated ability to fall asleep, do household chores and work due to speech difficulties, as having a greater impact; and worry about choking and trouble eating because of choking as having a lower impact. These findings demonstrate that TD has a substantial burden on patients' physical functioning regardless of the underlying condition, and reinforce the need for healthcare providers to routinely assess the impact of TD symptoms on eating, speaking, sleeping, and other activities of daily living.