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ExcelFemale
HRT in Women
Development of neuroactive steroids for the treatment of postpartum depression
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<blockquote data-quote="Nelson Vergel" data-source="post: 207892" data-attributes="member: 3"><p>This oral allopregnanone analog sounds promising.</p><p></p><p><strong>Zuranolone</strong>, also known as SAGE-217/BIIB125, is a synthetic investigational neuroactive steroid</p><p>GABAA receptor positive allosteric</p><p>modulator. Similar to brexanolone, zuranolone has affinity for both</p><p>synaptic and extrasynaptic GABAA receptors, although it has been designed with a </p><p>pharmacokinetic provision of oral bioavailability and once-daily dosing.⁸³ The efficacy of</p><p>zuranolone treatment with respect to improving depressive symptoms was demonstrated in</p><p>patients with MDD.⁸⁴ The first randomised, double-blind, placebo- controlled clinical </p><p>trial of zuranolone in PPD included 153 women age 18-44 years who were up to 6 months</p><p>postpartum and who had an onset of symptoms no earlier than the last trimester and up </p><p>to 4 weeks after delivery.⁸⁵ Key entry criteria included a total HAMD- 17 score ≥ 26 and medical</p><p>stability.⁸⁵ Patients were randomised 1:1 to receive either 30 mg of zuranolone or matching placebo capsules for 14 days and were followed for another 4 weeks remaining blind to </p><p>treatment.⁸⁵ Patients treated with zuranolone demonstrated a significantly greater decrease</p><p>from baseline in the primary endpoint of day 15 HAMD-17 total score (least squares mean </p><p>−17.8 vs −13.6 points; P = .003).⁸⁵ At the last assessment point (day 45), a statis-</p><p>tically significant separation between zuranolone and placebo was still observed (P =</p><p>.003).⁸⁵ In addition, day 15 response and remis- sion rates were significantly greater </p><p>in the zuranolone group (72% and 45%, respectively) compared to the placebo group (48% and 23%, respectively; both P < .05).⁸⁵ These positive findings have en- couraged further development of zuranolone for the treatment of PPD. At present, another phase 3 RCT is ongoing in the USA and Europe that is testing the efficacy and safety of 50 mg of zuranolone compared to placebo for the treatment of women with PP</p></blockquote><p></p>
[QUOTE="Nelson Vergel, post: 207892, member: 3"] This oral allopregnanone analog sounds promising. [B]Zuranolone[/B], also known as SAGE-217/BIIB125, is a synthetic investigational neuroactive steroid GABAA receptor positive allosteric modulator. Similar to brexanolone, zuranolone has affinity for both synaptic and extrasynaptic GABAA receptors, although it has been designed with a pharmacokinetic provision of oral bioavailability and once-daily dosing.⁸³ The efficacy of zuranolone treatment with respect to improving depressive symptoms was demonstrated in patients with MDD.⁸⁴ The first randomised, double-blind, placebo- controlled clinical trial of zuranolone in PPD included 153 women age 18-44 years who were up to 6 months postpartum and who had an onset of symptoms no earlier than the last trimester and up to 4 weeks after delivery.⁸⁵ Key entry criteria included a total HAMD- 17 score ≥ 26 and medical stability.⁸⁵ Patients were randomised 1:1 to receive either 30 mg of zuranolone or matching placebo capsules for 14 days and were followed for another 4 weeks remaining blind to treatment.⁸⁵ Patients treated with zuranolone demonstrated a significantly greater decrease from baseline in the primary endpoint of day 15 HAMD-17 total score (least squares mean −17.8 vs −13.6 points; P = .003).⁸⁵ At the last assessment point (day 45), a statis- tically significant separation between zuranolone and placebo was still observed (P = .003).⁸⁵ In addition, day 15 response and remis- sion rates were significantly greater in the zuranolone group (72% and 45%, respectively) compared to the placebo group (48% and 23%, respectively; both P < .05).⁸⁵ These positive findings have en- couraged further development of zuranolone for the treatment of PPD. At present, another phase 3 RCT is ongoing in the USA and Europe that is testing the efficacy and safety of 50 mg of zuranolone compared to placebo for the treatment of women with PP [/QUOTE]
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ExcelFemale
HRT in Women
Development of neuroactive steroids for the treatment of postpartum depression
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