Avanir presenting top-line data this week - BioMedReports (subscription) (blog)

[void]

Avanir presenting top-line data this week - BioMedReports (subscription) (blog)
04-12-2010 07:24 AM



Read Full Article Here...


(This thread was automatically posted from Google's RSS feed for news articles containing the term 'Dextromethorphan')

[torque]

Below are the concerns from the Approvable Letter and the answers to them from the STAR trial in the Special Protocol Assessment (SPA).


1) Concern: -Potential for QT interval prolongation

Answer: -New low dose formulations reduced quinidine exposure by 67%, reduced QTc outliers & should increase margin of cardiac safety

- No clinically meaningful changes in QTc, no pro-arrhythmic and no cardiovascular SAEs were seen in STAR trial


2) Concern: -Rate of AEs in “vulnerable” ALS population

Answer: Substantial reduction in rates of common AEs (nausea, dizziness, fatigue, etc.) compared to what was reported previously


3) Concern: -Potential for increased risk of falls

Answer: No difference b/w Zenvia 30/10 mg and placebo reported Incidence of falls


4) Concern: -Potential for respiratory depression in ALS

Answer: -No acute de-compensation of respiratory function observed after initiation of study drug
-Full analysis of nocturnal O2 saturation showed no difference versus placebo

If you've been watching the development of this drug (Zenvia®) it's interesting that potential for intoxication or abuse hasn't been raised as a possible concern yet.

[viscosity]

Seeing as it contains quinidine, I wouldn't think it would be the best choice for recreational use, not to say that someone won't try it. It looks like they’ve used dextromethorphan/quinidine doses of 30/10 and 20/10.
http://www.reuters.com/finance/stock...?symbol=AVNR.O

I'm curious how just DXM would feel like without DXO. It’s a shame dietary levels of quinine in tonic water do not inhibit CYP2D6.

[torque]

...from the bottom link

"This condition needs a therapy," Jung told MedPage Today. "These drugs seem to be effective, and no significant side effects or toxicity issues seem to be noted in the trial."


Jung noted that both drugs are well known. Despite its pedigree in cough medications, she said, dextromethorphan has been "found to be a very significant player in the parts of the brain responsible for behavioral control."

[viscosity]

Originally Posted by torque

dextromethorphan has been "found to be a very significant player in the parts of the brain responsible for behavioral control."

Interesting, I find this to be very true personally.
With regular DXM I have been able to stop taking prescription stimulants entirely (for ADHD). I think it is a field that needs further research, but I imagine the psychomimetic side effects would be a downside for many.