This is a note to those who are enrolled in Impax Lab's IPX066 Open Label Extension Study or anyone else who is concerned about the ethics of PD trials.

IPX066, is an extended release formulation of Carbidopa/Levodopa. I've been taking it for over a year and it has resulted in a significant improvement in the quality of my life.

From what I've heard, it has worked well with others and it's just a matter of time before it is approved for sale.

Unfortunately, I just learned that Impax Labs has not agreed to continue to provide IPX066 until it is available on the open market. This will force me and other enrollees to go back to using an inferior drug like Sinemet, which has a number of nasty side effects, including dyskinesia.

If you agree with me that the sponsor should continue to provide the study drug until FDA approval to those trial participants who request it, then it might be helpful if you wrote a note to the sponsor requesting that they change their policy.

You can write to the study director, Dr. Jeff Mulchahey. He can be reached at *edit* contact poster for details .

The details of this trial can be found at clinical trials.

that IPX066, this "new" extended-release carbi/levo formulation, was tested versus a placebo in one trial, and against immediate-release carbi/levo in an ongoing extension of the Phase III trials.

Not surprisingly, the results of the test versus placebo were a substantial (approx. 35%) improvement in the UPDRS parts II and III, reaching the targeted endpoints projected for the trial.

No results have been reported yet for the extension trial versus immediate release carbi/levo.

I wonder if this drug could reach the target endpoints if it were tested versus the already available controlled release formulations, either Merck's Sinemet CR or a generic.

One thing seems clear: If IPX066 is approved by the FDA, GSK and IMPAX will be marketing it at a major price increase over the available comparable drugs.

It is to be hoped that those of us who are successfully using existing controlled release formulations will still be able to obtain them

Thanks RLSmi for your post.

1. Regarding the comparison of IPX066 to currently available drugs, according to Impax, IPX066:

A. Provides rapid initial increase in concentrations comparable to Sinemet and Sinemet CR; and
B. Maintains sustained concentrations for a prolonged duration vs. Sinemet, Sinemet CR and Stalevo.

There's a chart in a presentation they made at a Jefferies conference that shows the data.

You can google "IPX066 Jefferies" to find it.

2. I see no reason why the availability of IPX066 will in any way affect the availability of existing drugs. Also, you're right that IPX066 most probably will be higher priced.

3. I participated in the ongoing double blind trial in which IPX066 was compared to Sinemet. It was very obvious to me when I had taken IPX066 and when I had taken Sinemet. IPX066 was far better at eliminating my PD symptoms and one dose lasted about 50% longer. BTW, I previously tried Stalevo, but had to drop it due to severe side effects. From what I can recall, IPX066 worked much better than Stalevo.

4. Finally, my main reason for posting this topic is not to compare one drug vs another, but to raise the ethical question of whether a drug company should continue to provide a trial drug to test volunteers if it is working far better than available alternatives. I feel very strongly that the drug company has this obligation in return for the test participant taking whatever risks are involved in the test program. I hope you agree with me and will contact Impax Labs to support this position. Thanks.

I did recognize that the primary purpose of your post was to call attention to the questionable (at least) ethics of refusing you who participated in the IMPAX trial access to a drug that seems to be highly effective in treating your symptoms.

I definitely will contact IMPAX and protest their lack of compassion in withholding IPX066 from trial participants who experienced very positive results and who wish to continue to use it for your own benefit.

In view of the past history of big pharma in such situations, I would be cautious about holding my breath while waiting for them to grant such compassionate access.

Robert

I really appreciate your support. Hopefully, many others will contact Impax.

Yesterday's press release from the company states that it has had success in its two double-blind trials and that it will file for FDA approval in the 4th quarter of 2011. This implies that approval will probably not be granted until late 2012.

Please contact the company and request that they extend the open label study until FDA approval is received.

Thanks again for your help.

I agree with you concerning availability of this drug when the study ended. It seems unethical to give patients an improved medicine then "pull the rug from
underneath them" after the trial is over. Especially since the improvement was
noticed the first time I took a dose.
If Impax labs does not want to give us compassionate medicine, then at least
let us have access to buy it with our neuro's prescription. But at least let us
have that option, don't just drop us. IPX-066 pushed my dosaging back to what
it was 6 years ago, 3X daily, as opposed to what i'm taking today, 5X a day.

That is despicable and they will say you did it for mankind. This isn't going to help us anytime soon [where have i heard that before]?

http://healthpolicyandreform.nejm.or...979&query=home

time and my study meds are runnine out. If you have been in this study join us snd contact Impax about having our trial meds cut off.
geraldo