Psycho-Babble Medication Thread 1102732

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SAGE-217 does well in phase 3 clinical trial

Posted by Hugh on January 10, 2019, at 9:35:57

After two weeks of treatment with SAGE-217, 45% of patients achieved remission (HAMD-17 <7) compared with 23% of patients who received placebo (p=0.0122); at the end of the four-week follow-up, 53% of patients receiving SAGE-217 achieved remission compared with 30% of patients who received placebo (p=0.0102).

"These are strong and consistent data demonstrating a rapid, stable, and clinically meaningful improvement in PPD depressive symptoms in the SAGE-217 treatment group compared to placebo," said Jeff Jonas, M.D., chief executive officer of Sage. "This is our fifth consecutive positive study in mood disorders with our investigational medicines that utilize our innovative approach to GABA receptor modulation. Data from the ROBIN Study, along with earlier data from our studies with ZULRESSO in PPD and SAGE-217 in major depressive disorder, all point to the promise that our approach may hold - not only in changing the way PPD and MDD are treated, but also in potentially improving the lives of patients suffering from these mood disorders. The team at Sage has shown what rethinking CNS really means."

Complete article:

https://www.businesswire.com/news/home/20190107005377/en/Sage-Therapeutics-Announces-SAGE-217-Meets-Primary-Secondary

 

Re: SAGE-217 does well in phase 3 clinical trial

Posted by Hugh on January 10, 2019, at 10:03:10

In reply to SAGE-217 does well in phase 3 clinical trial, posted by Hugh on January 10, 2019, at 9:35:57

This clinical trial was for postpartum depression. The positive results mean that it's likely that SAGE-217 will be approved by the FDA later this year. If this happens, it can be prescribed off-label for major depressive disorder, bipolar I/II, and insomnia. (There are currently SAGE-217 clinical trials underway for these disorders.)

If it's approved by the FDA, SAGE-217 will be the first truly new class of antidepressant to appear since the SSRIs were introduced over thirty years ago.

Based on the results of earlier clinical trials, it appears that SAGE-217 might only have to be taken once a month, or even less frequently.

 

Re: SAGE-217 does well in phase 3 clinical trial

Posted by Lamdage22 on January 11, 2019, at 6:48:26

In reply to Re: SAGE-217 does well in phase 3 clinical trial, posted by Hugh on January 10, 2019, at 10:03:10

Sweet. Looking forward to that!

 

Re: SAGE-217 does well in phase 3 clinical trial

Posted by Hordak on January 12, 2019, at 7:49:38

In reply to Re: SAGE-217 does well in phase 3 clinical trial, posted by Lamdage22 on January 11, 2019, at 6:48:26

I hope their claims are not exaggerated...

 

Re: SAGE-217 does well in phase 3 clinical trial

Posted by Hugh on January 16, 2019, at 9:22:14

In reply to SAGE-217 does well in phase 3 clinical trial, posted by Hugh on January 10, 2019, at 9:35:57

This is an interview with Jeff Jonas, CEO of Sage.

https://www.youtube.com/watch?v=hb8eMwyGjiQ


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