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Sage 217 for depression, anyway to try it before approval?

sage 217 depression novel antidepressant

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#1 diegot

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Posted 01 July 2019 - 11:34 AM


SAGE-217 is an investigational medication which is under development by SAGE Therapeutics for the treatment of major depressive disorder, postpartum depression, essential tremor, Parkinson's disease, insomnia, and seizures.[2][3] It is a synthetic, orally active, inhibitory pregnane neurosteroid, and acts as a positive allosteric modulator of the GABAA receptor.

 

I am looking after this compound since more then one year, it seems to be a great hope for all people suffering of depression.

All trials went in a really amazing way, results are great.

Only problem is, how long should I wait to see if this works?

  • 02 May 2019 Sage Therapeutics plans a placebo-controlled re-treatment trial for Major depressive disorder (Monotherapy), in the third quarter of 2019
  • 23 Mar 2019 Sage Therapeutics completes a phase II trial in Bipolar Disorder in the US (NCT03692910)
  • 27 Feb 2019 Sage Therapeutics initiates enrolment in a phase III trial for Major depressive disorder (NCT03864614)

Anybody interested in this compound?


Edited by diegot, 01 July 2019 - 11:35 AM.


#2 Daniel Cooper

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Posted 01 July 2019 - 07:16 PM

In my experience, GABA PAMs used for any significant period of time are bad juju.

 

 

 

 

 


  • unsure x 1

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#3 diegot

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Posted 03 July 2019 - 02:53 PM

Last updates about this new compound, I wonder if after MOUNTAIN Study SAGE 217 will have a chance to get FDA approval for short depression treatment

 

What do you think?

 

 

SAGE-217: The pivotal program evaluating the potential of SAGE-217 as a short-course episodic, rapidly-acting oral treatment for MDD and PPD is progressing on target. This program includes two completed, positive pivotal studies, one in MDD and one in PPD.

  • In January 2019, Sage announced statistically significant top-line results in primary and secondary endpoints from the Phase 3 ROBIN Study of SAGE-217 in women with severe PPD. These results demonstrated a rapid, stable, and clinically meaningful improvement in depressive symptoms in the SAGE-217 treatment group compared to the placebo group after two weeks of treatment. The effect was maintained through the end of the four-week follow-up period. The most common adverse events in the treatment group were somnolence, headache, dizziness, upper respiratory tract infection, diarrhea, and sedation. Two subjects experienced serious adverse events, one in each treatment group.
  • Ongoing or planned studies in the program include:
    • MOUNTAIN Study: Evaluates a dosing regimen of two weeks of 20mg or 30mg SAGE-217 treatment compared to placebo in approximately 450 patients with MDD, with four weeks of blinded follow-up. Top-line data from the study are expected in Q4 2019 or Q1 2020. As a separate observational phase, the Company will continue to follow patients for up to six months.
    • Retreatment studies:These studies are designed to provide longer-term retreatment and follow-up safety and tolerability data.
      • MDD-302 will evaluate fixed interval SAGE-217 monotherapy maintenance (treatment without traditional antidepressants) for up to a year. This placebo-controlled trial is expected to commence in 3Q 2019 and, if successful, is intended to help meet the expected requirements for a New Drug Application for SAGE-217, and enable inclusion of maintenance dosing as part of the label.
      • The SHORELINE Study evaluates 30mg SAGE-217 open-label treatment, treatment-free intervals and as-needed retreatment for return of major depressive episodes over the course of up to a year. Patients will receive an initial two-week course of SAGE-217 therapy and will be assessed every eight weeks for potential relapse of depressive symptoms. Data are expected in 2020.
    • RAINFOREST Study: Evaluates two weeks of 30mg SAGE-217 treatment compared to placebo in approximately 100 patients with MDD and comorbid insomnia. Top-line data are expected in 2020.
  • The Company is also evaluating SAGE-217 in the Phase 2 open-label ARCHWAY Study in approximately 30 patients with bipolar I/II disorder with a current major depressive episode. Primary endpoints are safety and tolerability; secondary endpoints will measure improvements in depressive symptoms and sleep. Sage plans to announce top-line data from this study in July 2019.
  • The Company is also evaluating the potential for development of SAGE-217 in additional affective disorders and expects to provide an update on those plans in July 2019.






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