Have you heard of IPX203? Claims to be superior to C/L? and NO dyskinesia?

[PDWarrior1900]

youtu.be/8U7AL_DSA9E(Not working as expected?)

[Boscoejean]

I was wondering whether this was designed to duplicate the levels of levodopa and carbidopa in Sinemet and was reading the research to try to find out what level of each is in this medication. It said in the study that they were using double dummy pills as the placebo. I have to wonder how this went for people who had been taking Sinemet for a while and then went on the placebo pills. It seems like it would be a significant change in their functioning. I have read that Sinemet has to be tapered off if a person needs to discontinue taking it. One question I thought of is if someone was taking this over time would there not be a need to increase the dose as quickly. Another question if the person could be started on a low dose could there be more benefits vs negative effects over time. If the medication is taken every 8 hours does that mean that the person would be taking this medication at bed time and would this have an effect on sleep since I have read that sinemet is sometimes not taken in the evening before bed

[PDWarrior1900 in reply to Boscoejean]

good thoughts.... i don't know if this new drug is still in trials or what... but this recent video caught my attention and I thought I'd share it....

[Boscoejean in reply to PDWarrior1900]

the video was good because the guy was brief and to the point and actually had something to say and didn't drag the whole thing out for an hour or two - I appreciate this kind of presentation

[park_bear in reply to Boscoejean]

They would not and did not use placebo as comparator: " In the RISE-PD study, IPX203 met the study’s primary endpoint by demonstrating a statistically significant improvement in efficacy for IPX203 compared to IR CD/LD."

Also for some of us C/L before bed is helpful.

[Fed1000]

Too good to be true.

[PDWarrior1900 in reply to Fed1000]

i finally checked, it is REAL!

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neurologylive.com/view/fda-...

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"According to an announcement by Amneal Pharmaceuticals, the FDA has accepted its new drug application (NDA) for IPX203, a novel, oral formulation of carbidopa/levodopa (CD/LD) extended-release capsules intended to treat patients with Parkinson disease (PD). The FDA has scheduled a PDUFA date of June 30, 2023, to complete its evaluation of the NDA.1"

[Fed1000 in reply to PDWarrior1900]

They say that with the assumption of the new drug the doses to be taken are reduced with a longer duration of sympton control but the absence of dyskinesias remains to be demonstrated, in my opinion.

[park_bear in reply to Fed1000]

Per link below: " treatment-emergent adverse events (TEAEs). Most TEAEs were either mild or moderate in severity and occurred within the first 90 days of treatment. Of them, the most common were dyskinesia (5.0%),"

[Gallowglass]

be careful of new drugs. PD is big business.

[PDWarrior1900 in reply to Gallowglass]

i rarely get political because i don't want people to get ANGRY with me here...

but I AGREE!... The big pharma/ medical institutions don't MAKE MONEY if we are 'cured' or ... DEAD.

They only only only..... MAKE MONEY ... if they keep us SUFFERING.

[gomelgo in reply to PDWarrior1900]

This is one of the main reasons I am avoiding the meds.

[Bolt_Upright]

AAN 2023: Amneal’s IPX203 shows promise for Parkinson’s disease patients

GlobalData Healthcare: IPX203 is currently under review by the FDA for the treatment of Parkinson’s disease (PD), with a PDUFA date of 30 June 2023. clinicaltrialsarena.com/com...

"IPX203 is an extended-release formulation that consists of a combination of immediate-release (IR) CD/LD granules and extended-release (ER) beads of levodopa. The ER beads are coated with a sustained-release polymer to allow for slow drug release, a mucoadhesive polymer to keep the beads adhered to the area of absorption longer, and an enteric coating to prevent the beads from disintegrating too early in the stomach. In the RISE-PD study, IPX203 met the study’s primary endpoint by demonstrating a statistically significant improvement in efficacy for IPX203 compared to IR CD/LD. IPX203 treatment resulted in 0.53 more hours of “Good On” time than IR CD/LD when comparing change from baseline in both study arms. “Good On” time is defined as the total time with either non-troublesome dyskinesia symptoms or duration without dyskinesia.

In the OLE study data presented at the AAN 2023, the magnitude of efficacy obtained with IPX203 was sustained in patients from baseline to the end of the OLE study. In the study, 52.7% of subjects experienced treatment-emergent adverse events (TEAEs). Most TEAEs were either mild or moderate in severity and occurred within the first 90 days of treatment. Of them, the most common were dyskinesia (5.0%), fall (5.0%), urinary tract infection (5.0%), back pain (3.6%), and constipation (2.6%).

However, some KOLs indicated that the improvement in efficacy with IPX203 compared with IR CD/LD was not significant to impact their treatment patterns, particularly if IPX203 is anticipated to have premium pricing. But IPX203 could be an option for patients who have not had a good experience with Rytary. A further competitive threat to the future of IPX203 and other oral LD/CDs is the development of novel subcutaneous levodopa delivery systems. KOLs showed great enthusiasm for AbbVie’s ABBV-951 and NeuroDerm’s ND0612, which enable continuous infusion of LD/CD and could create additional options to control various motor complications in moderate to advanced-stage patients."

[Gcf51]

OK, I’m not up on what things mean.

The Prescription Drug User Fee Act (PDUFA), date thus serves as a 'best estimate' of when a decision on a New Drug Application or a Biologics License Application would be forthcoming. This response may be a decision to approve the application or a Complete Response Letter (CRL). en.wikipedia.org/wiki/PDUFA...

Could be an approved drug in 10days

[zerynthia]

@@

[katherinecompton22]

The NP at my movement disorder clinic is pretty excited about this med. I participated in AbbVie’s ABBV-951 clinical trial (continuous subcutaneous infusion) and will avoid having to use any pumps as long as I can.

[PDWarrior1900 in reply to katherinecompton22]

thank you for the good feedback! We all wish you SUCCESS!

[Javalove in reply to katherinecompton22]

Am I understanding you to say you would not choose an infusion method of delivery because of your experience? Not familiar with it, just wanting to make sure I’m understanding correctly. Thank you!