Psycho-Babble Medication Thread 1115627

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Short-Course Zuranolone Looks Promising for MDD

Posted by PeterMartin on June 21, 2021, at 21:55:44

Hadn't heard of this before.....hope it works out and becomes available relatively soon....
____

Positive results were announced from a phase 3 study evaluating zuranolone (SAGE-217/BIIB125) for the treatment of adults with major depressive disorder (MDD).

Zuranolone is an investigational oral neuroactive steroid GABA-A receptor positive allosteric modulator that is administered once daily for 2 weeks. The double-blind, randomized, placebo-controlled WATERFALL study (ClinicalTrials.gov Identifier: NCT04442490) included 543 adults 18 to 64 years of age with MDD.

Patients were randomly assigned to receive either zuranolone 50mg or placebo once daily for 14 days. The primary endpoint was the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17) total score at day 15. Key secondary endpoints included the change from baseline to day 15 in the Montgomery-Åsberg Depression Rating Scale (MADRS), the Hamilton Anxiety Rating Scale (HAM-A) total score, and the Clinical Global Impression-Improvement (CGI-I) Response.

Results showed that at day 15, patients in the zuranolone treatment arm demonstrated a statistically significant and clinically meaningful improvement in depressive symptoms as measured by HAMD-17 total score (LS mean difference, -1.7 points; P =.0141). Patients with a response at day 15 retained on average 86% of their HAMD-17 improvement at day 42 (4 weeks after dosing ended).

Zuranolone was also associated with significant improvements in key secondary endpoints including MADRS (LS mean difference, -2.4; P =.0238), HAM-A (LS mean difference, -1.4; P =.0199), and CGI-I response (odds ratio, 1.5; P =.0191).

The most common treatment emergent adverse events observed in patients treated with zuranolone compared with placebo included somnolence (15.3% vs 3%), dizziness (13.8% vs 2.2%), headache (10.8% vs 7.8%), and sedation (7.5% vs 0.4%). There were no signals for withdrawal symptoms or for increased suicidal ideation or behavior.

Additional data from the WATERFALL study will be presented at a future medical meeting

 

Re: Short-Course Zuranolone Looks Promising for MDD

Posted by linkadge on June 22, 2021, at 15:16:46

In reply to Short-Course Zuranolone Looks Promising for MDD, posted by PeterMartin on June 21, 2021, at 21:55:44

Very cool. Nice to see some different mechanisms.

Linkadge

 

Re: Short-Course Zuranolone Looks Promising for MDD

Posted by SLS on June 29, 2021, at 16:07:59

In reply to Re: Short-Course Zuranolone Looks Promising for MDD, posted by linkadge on June 22, 2021, at 15:16:46

> Very cool. Nice to see some different mechanisms.
>
> Linkadge

I had been looking at zuranolone (SAGE-217) beginning in 2019 after the I.V. post-partum drug, brexanolone (Zulresso), was approved. Both drugs were developed by the same drug company as part of a series of related compounds. Zuranolone was the second of the series to be chosen for clinical trials. Hopefully, I will never need it. It was going to be the very next thing I would have tried had I not found success with my current treatment.

Positive allosteric modulators bind to a secondary site on a receptor such that it changes the shape of it. This makes the GABA-A receptor more sensitive to GABA.

These new drugs are related to the progesterone-like substance, allopregnanolone


- Scott

 

Re: Short-Course Zuranolone Looks Promising for MDD

Posted by TriedEveryMedication on July 2, 2021, at 10:07:34

In reply to Short-Course Zuranolone Looks Promising for MDD, posted by PeterMartin on June 21, 2021, at 21:55:44

"A potential limitation of brexanolone is the estimated cost of $34,000 for one continuous infusion,"

 

Re: Short-Course Zuranolone Looks Promising for MDD

Posted by SLS on July 5, 2021, at 11:19:02

In reply to Re: Short-Course Zuranolone Looks Promising for MDD, posted by TriedEveryMedication on July 2, 2021, at 10:07:34

> "A potential limitation of brexanolone is the estimated cost of $34,000 for one continuous infusion,"


Brexanolone (Zulresso) is approved as an I.V. drug, and is approved for postpartum depression only.

Zurazolone is to be taken orally. This is the drug that I had been waiting for a few years. Sage Therapeutic (and Biogen) have conducted a Phase III clinical trial that reports a favorable therapeutic effect. It looks like zuranolone might be approved for postpartum depression, major depressive disorder, and bipolar depression.

https://investors.biogen.com/news-releases/news-release-details/sage-therapeutics-and-biogen-announce-positive-pivotal-phase-3


- Scott

 

Re: Short-Course Zuranolone Looks Promising for MDD

Posted by Ruuudy on July 23, 2021, at 2:55:49

In reply to Re: Short-Course Zuranolone Looks Promising for MDD, posted by SLS on July 5, 2021, at 11:19:02

https://medcitynews.com/2021/06/while-sage-therapeutics-sees-a-window-for-depression-drug-market-is-skeptical/


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