LTS to Manufacture New Levodopa Capsule Formulation for Intec Pharma

Parkinson's Therapy Levodopa's New Formulation to Be Made by Germany's LTS

This new pill tecnology will, to use a hackneyed expression, be a game changer. This will be better than the Neuroderm pump. What kind of time frame are we looking at before it is available?

What strikes me about this report of a new formulation of L/C is that the ratio of carbidopa to levodopa, is not fixed:
- For low levodopa doses (500mg/day) the ratio is 1:5 (cf 1:4 which is nowadays the norm).
- For high doses (1000mg/day) the ratio is 1:10.
Perhaps carbidopa levels are something that we should consider?

Intecpharma write:

[1] "The AP-CD/LD doses tested were 50/250 mg for 7 days (Group 1), 50/375 mg for 7 days (Group 3), 50/375 mg for 21 days (Group 4), and 50/500 mg for 21 days (Group 6) administered BID (twice a day).

The primary end-point of the study was to evaluate the change in the Total daily OFF Time between AP-CD/LD and current optimized LD treatment. Total OFF Time was decreased, with the AP-CD/LD, by 44% and 45% in groups 4 and 6 respectively.

The reduction in total OFF Time was achieved without increasing the ON Time with Troublesome (TS) Dyskinesia in group 4 and with decreasing Total ON Time with Troublesome Dyskinesia in group 6, resulting in an increase of Total Good On Time of 2.1h and 2.7h, respectively, in comparison to current optimized LD treatment."

[2] "The results demonstrated that plasma concentrations of carbidopa and levodopa were similar, with no statistically significant differences in all PK parameters measured, when AP-CDLD was taken with various food compositions. This suggests that the treatment with AP-CDLD, intended to be taken b.i.d (two times a day) or t.i.d (three times a day) with food, is independent of the food content."

References:

[1] AP – CD/LD - IntecPharma

[2] Topline Results of a Food Effect, Pharmacokinetic Study of AP-CDLD 5/5mg for the Treatment of Parkinson's Disease Symptoms - IntecPharma

John

Doesn't suprise me. I take one half of a 10/100 CD/LD pill with a single capsule of mucuna (100 mg. LD) several times/day (usually 6) ....I tried taking carbidopa only with mucuna and didn't feel the mucuna take effect. although the ON time duration is only 2-3 hours... I am so glad I experimented as I think I don't do as well with higher CD doses.

MD

not sure if "better" is the right term, the pump bypasses the digestive system so if that is where the problem lays, i.e. slow gastric emptying, leaky gut,etc. i would speculate the pump would be better than this accordion pill. and i have to assume that the pump delivered l-dopa dosage will get to the brain sooner than anything you take orally so i would expect you would reach "ON" sooner. the drugs for the pump are at least 3x more expensive though.

i'll throw this out, to make the old time regular release (IR) and controlled release(CR) 100% more "USEFUL" as you progress, encourage competition among generic manufacturers and less consolidation, what are there, 3 generics left after TEVA sold their generic C/L and you can't get that formulation anymore, please correct me if i'm wrong. sounds trivial but not to me. but more importantly, what a lot of us could benefit from is a good rescue drug like inhaled l-dopa and the sublingual apomorphine strip, something that bypasses the digestive system. that would be the cheapest improvement. at my stage of pd, where i'm taking just C/L - battling to try to tolerate pramipaxole but it's not looking good - food is my worst enemy. now maybe these yet to be released products are greatly affected by food, they still have to run interference thru any amino acids similar to l-dopa that is in your blood, but i'm assuming they will benefit you, especially if you take them 30-40min before eating and give them a head start. so you could conceivably work out a routine with regular IR and CR and the "rescue" drugs if/when they come to market. just amazes me how much these new C/L drugs cost, isn't RYTARY something like $800/month?