Annoying tremor? Zuranolone as an oral adjunct to treatment of Parkinsonian tremor: A phase 2, open-label study

[Farooqji]

Highlights

•Zuranolone (SAGE-217) is an investigational oral neuroactive steroid GABAA receptor positive allosteric modulator (PAM).

•Zuranolone was administered for seven days in 14 patients with PD, and reduction of tremor symptoms was assessed.

•The MDS-UPDRS Part II/III tremor score improved 40% (p < 0.0001) from baseline on Day 8.

•The motor score and non-motor and motor EDL scores (MDS-UPDRS Parts I and II, respectively) also improved at Day 8.

•No serious AEs were reported, and no patients discontinued treatment.Zuranolone

sciencedirect.com/science/a...

[healthabc]

thank God! At least there's something to hope for-

[sharoncrayn]

IQ:

RE:SAGE-217

I thought this SAGE THERA/BIOGEN drug "failed" in previous antidepressant CTs (MOUNTATIN). I don't understand the long term implications of using this drug unless it is very specific to PD, which apparently it can be.

Very small (n=14)...7 or 14 day administration test, for late stage PD...extremely positive, unfortunately no lag analysis available.

Long way to go.

Sharon

[Cagey84 in reply to sharoncrayn]

Hi Sharon - it seems there is even longer to go as SAGE-217 is no longer mentioned in the company pipeline for PD - sagerx.com/programs-researc... . The focus is now on depression. Shame.

[sharoncrayn in reply to Cagey84]

CG,

Confusing to say the least, but i thought Biogen bought the rights for $3Billion or entire company.

Besides, the case size was so small and so short, I wonder about "pygmalion" EFFECTS a la DBS, etc. outside a medical center setting. Was it for real? Was the tremor reduction "subjective". 40% is a huge reduction if baseline was significant. Not so much if #s were low to begin with. Very important.

However,

"Subject must have a diagnosis of ET, defined as bilateral postural tremor and kinetic tremor, involving hands and forearms, that is visible and persistent and the duration is >5 years prior to screening." = at least moderate PD IMO.

Sometimes it is simply a $$$ decision.

Sharon