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MinnieM

05/09/15 11:30 AM

#101531 RE: biodoc #101525

Thanks for taking the time on this.




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Drano

05/09/15 12:45 PM

#101535 RE: biodoc #101525

Excellent summary, biodoc, thanks. (eom)
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To infinity and beyond!

05/09/15 2:32 PM

#101547 RE: biodoc #101525

very helpful summary and nice of you to take the time. I had not seen prev explanations and was just searching around the earlier posts that I mentioned in my prev post.

It is lucky that you have some background in these matters and you are generous with your time.
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frrol

05/09/15 2:58 PM

#101553 RE: biodoc #101525

I don't get the IV con either, but because it's been formulated for pills, creams, and drops. Or am I missing something?
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Tails

05/10/15 10:52 PM

#101720 RE: biodoc #101525

Thanks Biodoc. Very helpful.


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Smooth

05/15/15 2:43 PM

#102522 RE: biodoc #101525

Found this on SAlpha:


Anybody worried about the blood pressure effects with brilacidin? Not bad at 0.6 mpk but significant at 0.8 mpk and serious with 3 day dosing. Think doctors will choose this drug first when there are now quite a few other new antibiotics that have been approved in the past 2 years with clean safety profiles? Perhaps they dosed too high since all three arms in the study gave very similar results.





and was just wondering if your response addresses the blood pressure concern?

• reversible adverse effects
(paresthesia, ? blood pressure and heart rate)
Also addressed. This is a 'con' but doesn't appear to be limiting.
First, note the the systolic blood pressure (SBP)cutoff decreased from 180 to 160 from Phase 2a to 2b. Second, consider that a significant percentage of the population presents to the ER with (SBP) > 160. I'm more interested in the change in SBP during infusion to see if SBP changes are really a con and how significant it might be. I have not found any information suggesting change of heart rate with Brilacidin infusion so I'm not too concerned that this is a problem. Also, most ABSSSI patients have significant fever, which as you know, is usually associated with a more rapid heart rate. Again, is there a change in HR during infusion that is concerning? Neither Phase 2a or 2b in any way suggests that this is a problem so I don't think change in HR is a real 'con.'

Paresthesias are the one adverse effect that I was most concerned about. Apparently, the paresthesias are mild and transient and related to sodium channel blockade. In that the paresthesias don't persist and Brilacidin appears generally well tolerated, I see paresthesia as a 'con' as it is an adverse effect. In that the drug is well tolerated, I see it as a weak con that will not limit Brilacidins clinical usefulness.