Auvelity's 12 month Remission Rate of 67-69% vs Most Trials 11-40% | AXSM Message Board Posts


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Msg  1658 of 1769  at  11/28/2023 4:15:01 PM  by

biobetter

The following message was updated on 11/28/2023 4:31:25 PM.

Auvelity's 12 month Remission Rate of 67-69% vs Most Trials 11-40%

>Remission basically means back to normal. This open-label data may help convince insurances to allow patients to stay on Auvelity for up to 1 year.<
"Thase has reported that more than one third of depressed patients will reach remission after acute antidepressant treatment.Citation16 Most clinical trials report remission rates of 22% to 40%, while effectiveness studies including representative samples of depressed patients closer to clinical practice report lower remission rates - around 11% to 30%"
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POSTER PRESENTATIONS
Two posters detailing long-term, open-label studies with dextromethorphan-bupropion have been presented at annual meetings. The first of these posters presented the results from the COMET Phase 3 Trial at the 2021 American Society of Clinical Psychopharmacology Annual Meeting. Patients in this trial were treated with dextromethorphan-bupropion 45−105 mg twice daily for up to 12 months [21]. Inclusion/exclusion criteria were like previously mentioned studies. This trial found a rapid reduction in MADRS total score that was maintained th-rough month 12, with a mean reduction from baseline of 23 points at the end of the study period (n = 611). Clinical response (≥ 50% reduction in MADRS total score) was achieved by 82.8% of patients at month 12, and clinical remission (MADRS total score ≤ 10) was achieved by 69.0% of patients at month 12. The main adverse events (n = 876) experienced were dizziness (12.7%), nausea (11.9%), headache (8.8%), dry mouth (7.1%), and decreased appetite (6.1%). No serious adverse events were reported.
 
The second poster presented the results from the EVOLVE open-label, long-term study at the 2022 American College of Neuropsychopharmacology Annual Meeting. One hundred and forty-five patients in this trial were treated with dextromethorphan-bupropion 45−105 mg twice daily for up to 15 months, with similar inclusion and exclusion criteria as mentioned previously [22]. Significant improvements were reported on MADRS total scores, Cognitive and Physical Functioning Questionnaire, Sheehan Disability Scale, and the Hamilton Anxiety Rating Scale. Significant robust findings on each of these assessment scales were seen by week 1. Similar to the COMET trial, clinical response and remission were achieved at month 12 by 81.9% and 67.5% of patients, respectively. The most common adverse events (n = 146) were COVID-19 infection (8.9%), nausea (8.9%), headache (7.5%), dry mouth (6.2%), dizziness (5.5%), and insomnia (5.5%). The poster reported serious adverse events in 5 patients (3.4%) but did not specify what these adverse events were.
 
Dextromethorphan-bupropion (Auvelity) for the Treatment of Major Depressive Disorder
 
  


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