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Animals were fasted overnight, then administered capsules containing formulated test substances or the same peptides s.c
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Results from 327 women demonstrated: Significant increases in satisfying sexual events compared to placebo at 1.25 mg and 1.75 mg doses Improved Female Sexual Function Index total scores (mean improvement of 3.6 points vs 1.9 for placebo) Reduced sexual distress as measured by Female Sexual Distress Scale scores Dose-dependent response with optimal effects at 1.75 mg Two Phase 3 trials (RECONNECT studies) enrolled over 1,200 premenopausal women with acquired, generalized HSDD and confirmed efficacy at the 1.75 mg dose administered subcutaneously at least 45 minutes before anticipated sexual activity
The biosimilar applicant has 60 days to respond with its own patent list and claim charts explaining why each patent is invalid, unenforceable, or not infringed
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