NeuroDerm Announces Positive Topline Results of Phase II Trials
 

We've spoken about NeuroDerm and their continuous, subcutaneously-delivered liquid LD/CD product, ND0612, on several different threads recently. So, I figured I would just start this thread with their announcement of Phase Ii results. Not surprisingly, they were great and the company will continue moving forward with more trials that are required for eventual FDA approval.

This was, however, a good news bad news story. The good news was the very positive results with little, if any, side effects (as opposed to Abbvie's Duodopa gel and pump surgery). The bad news is that the company estimates that if everything goes according to plan, the pump and liquid LD/CD will be available for general use in 2018. It just seems to me to be outrageous that it should take so long to test and get an approval for a liquid formulation of a drug that has been available on the market for over 40 years and a basic insulin pump which are used everyday by diabetics. NeuroDerm received their first MJFF grant in 2010. So 8 years to approval, if everything goes right.....hmmmmm, doesn't seem right to me.

Gary

http://www.prnewswire.com/news-relea...280818122.html

I wonder how much of the long approval time is due to just finding enough volunteers?
then you have just plain incompetence from companies like IMPAX labs who can't bring their new extended release C/L to market because of substandard mfg'ing practices.

can't forget that DBS still has a role in advanced PD and hopefully more improvements are in the pipeline.

and lets hope the gene therapy, stem cell, porcine implants and fetal transplant trials that are in process or about to start are successful.

It takes big bucks to pay to play with the FDA.

Yes, it does, and when they complete their IPO over the next few weeks they'll be well funded to see it through the finish line.

This company is no IMPAX, by any means. Way more advanced and professional. But, no doubt finding volunteers is difficult. It really slows down the process.

New Data
 

Neuroderm surged today on the announcement of more positive test results.
They announced that continuous, subcutaneous delivery of the company's proprietary liquid levodopa/carbidopa (LD/CD) product candidates, ND0612H and ND0612L, led to clinically-significant plasma levodopa levels. These results suggest that the high dose version, ND0612H, intended for severe Parkinson's disease patients, may provide an effective therapy alternative to current treatments requiring surgery (say goodbye to Abbvie's duodopa).


The primary endpoints of the IIa study were to assess the safety, tolerability and pharmacokinetics (PK) of six dose regimens of ND0612H and ND0612L, which provide continuous, subcutaneously-delivered liquid LD/CD formulations through a belt-worn pump, in Parkinson's disease patients. Sixteen (16) advanced PD patients, with motor fluctuations, chronically treated with standard of care oral LD/CD, were enrolled in the study and were treated with ND0612L (n=9) or ND0612H (n=7) for eight hours per day, for three consecutive days, with high and low doses of CD, and with adjunct oral entacapone. The pharmacokinetics of LD/CD were assessed and compared to baseline pharmacokinetics of orally administered, immediate release LD/CD tablets. A top-line, intent-to-treat analysis showed that levodopa plasma levels were proportionate to dose and, with ND0612H, achieved maximum daytime concentrations of 1,333ng/ml and 1,436ng/ml (with different CD concentrations in the formulation), and 1,807ng/ml with adjunct dosing of oral entacapone. ND0612L achieved maximum daytime concentrations of 528ng/ml and 477ng/ml (with different CD concentrations in the formulation), and 596ng/ml with adjunct dosing of oral entacapone. Fluctuations in LD plasma levels were markedly reduced when comparing oral LD/CD dosing to ND0612H and ND0612L. Per-protocol analysis, that omitted three data sets from two patients because of concomitant use of oral LD, yielded similar LD plasma values.

Treatment with ND0612L and ND0612H did not raise safety and tolerability concerns, causing only minimal and transient local reactions at the infusion site and no particular systemic adverse events, which corroborates the results obtained in previous studies. All patients completed the study.

"These results add to the growing body of clinical data confirming our thesis that continuous, subcutaneous delivery of LD/CD leads to more consistent therapy, which we expect to have a dramatic effect on patient outcomes and quality of life, replacing in most cases the need for surgical intervention," said Oded S. Lieberman, PhD, CEO of NeuroDerm. "Based on these positive PK results, we will proceed with the clinical development of ND0612H and ND0612L in the United States and the European Union in 2015."


http://ir.neuroderm.com/phoenix.zhtm...cle&ID=2002254