Rytary Reformulation

[Blackfeather]

Is Rytary being reformulated to last 8 hours per dose? Anybody know anything about this?

mdedge.com/clinicalneurolog...

[sharoncrayn]

This experimental reformulation was examined in a Phase 2 clinical trial that goes back to 2015-2017. Too small in participation numbers to be truly significant. Personally, I don't see the value of this reformulation of a drug that is already a reformulated drug.

For the uninitiated, the issue in PD pharmacology isn't about extending the time of levodopa per se. The issue is: is any reformulation more effective at reducing or minimizing PD symptoms (i.e. more "on" time) than the original drug that has been approved and is the improved performance truly significant.

Further concerns center around the results from the ASCEND trial (for the current Rytary reformulation) and its relatively high percentage of adverse events. Adverse events totaled approximately 20% which is not trivial. Therefore, it remains to be seen whether or not this reformulation in an eventual Phase 3 trial would exceed that level. My assumption is that it probably would.

Sharon

[TR8Man in reply to sharoncrayn]

Sharon - Just to be clear, are you saying the percentage of Adverse Events would exceed 20% in a Phase 3 Trial?...or am I confused...?....so, what is the motivation for continuing with additional trials? Either way, thank you for your work. Being new to PD and Rytary, I have a lot to learn.....

[sharoncrayn in reply to TR8Man]

TR8man:

I am assuming that if they held a Phase 3, (I haven't heard or read about it) it wouldn't surprise me if the percentage of adverse events met or exceeded 20% given the attempt to extend the duration of the levodopa effect from the current formulation. Furthermore, some of these adverse events in ASCEND trial were significant events. They weren't trivial.

" Six serious adverse events were recorded,

including atrial fibrillation, constipation, gastroenteritis, dehydration,

hyperkalemia and sciatica during CLERC treatment..."

Whether or not these adverse events were due to the "exclusion/intrusion" criteria or the drug itself or some combination is difficult to know without much more information.

Significant adverse events were also found with males using Stalevo (significant incidence of prostrate cancer) in that drug's most recent clinical trial although it is still popularly prescribed in the UK and EU.

[TheLordsWeapon]

very interesting, first ive heard of it,t thx