Midodrine In The News Again Today

[MightyMouse]

From

http://everythinggold.blogspot.com/2010/12/chelsea-therapeutics-nasdaqchtp.html

Chelsea Therapeutics (NASDAQ:CHTP) Regulatory Timelines Accelerated

With Study 306 no longer considered pivotal for Droxidopa NDA, the timeline for Chelsea Therapeutics (NASDAQ:CHTP) should be shrunk by a quarter.

Needham said, "Chelsea management announced this morning that, as a result of recent pre-NDA meetings with the FDA, the company now plans to submit a Droxidopa NDA based on data from only the first two Phase 3 trials (Studies 301 and 302). The ongoing Study 306 is no longer considered a pivotal study. This is expected to accelerate regulatory timelines by about a quarter, allowing NDA submission in 2Q11. The news appears to reflect interest by the FDA in finding a suitable replacement for midodrine, which the FDA is seeking to pull from the market. We caution investors, however, that outcome of the ongoing Study 306 is still likely to influence FDA review. Consequently, although we are favorably inclined with respect to Study 306 outcome, clinical trial risk (in addition to regulatory risk) still must be factored in the stock."

[dsdmom]

Great find! Must be why my neurologist mentioned that he thought droxidopa would be approved next year. I'm looking forward to this one...he thinks it will be a good one (he's participating in the studies).

[Sophia3]

I'm CONFUSED. IT says Midodrine in the title but the post/link do not mention it.

Please ENLIGHTEN me.

And is this drug OFF the market again. I don't currently use it but LOVED.IT!

[Chaos]

This is the new drug that many of us wouldn't tolerate because of its effects on the catecholamines, right? Would not be a good one for many of us who rely on Midodrine, or at least that was how it seemed given the discussions last time the FDA threatened to remove Midodrine.

[MightyMouse]

Sophia, read again. It says that they intend to approve droxidopa as a substitute for midodrine. This would tend to lead one to assume that one would substitute b/c the other isn't an option. Also, a news article I got last week indicated Shire is probably going to drop production of midodrine. We'll see what happens is all I can say.

Nina

[iheartcats]

Isn't this dependent on studies and approval? It could get approved much later this year so I hope they continue Midodorine at least through 2011!

[sandymbme]

I can only just barely stay conscious with 10mg of midodrine 3x a day! It keeps my bp hovering around 100/60 seated, 85/55 or so standing. I really don't know what I'll do without it! My bp was so wildly out of control without it, almost died one hospitalization because my bp literally flatlined! Crap!

Sandy

[Crow]

Chelsea Thereputics clinical trial of their orthostatic hypotension drug failed:

http://www.reuters.com/article/2011/02/02/chelseatherapeutics-idINSGE7110AP20110202

[Crow]

Jim Cramer linked to this on twitter:

Chelsea Tries Spin Job on Failed Drug Trial

http://www.thestreet.com/story/10992990/1/chelsea-tries-spin-job-on-failed-drug-trial.html

[Noreen]

Jim Cramer linked to this on twitter:

Chelsea Tries Spin Job on Failed Drug Trial

http://www.thestreet...drug-trial.html

Thanks for posting the links.

I found this quote to be almost laughable, however, as I have lost faith in the FDA.

" raising obvious concerns that the drug will not fare well under a stringent review by U.S. drug regulators."

[green]

This seems like seriously bad news for Droxidopa.

CHTP has had to change the endpoint twice now - originally they tried to use a measure of dizzyness as the endpoint, then they used a broader measure of OI symptoms, now they want to use # of falls?

It seems to me that this would be bad science - if you tried to change what variable you were measuring after you had done the study. I suppose that since # of falls was a secondary endpoint, this is not what they were doing. They had already decided to measure # of falls before they did theexperiment. But it still seems fishy. What stops a company from declaring many secondary endpoints and then adopting whichever one they want as the primary in retrospect?

It's like if I were to say:

"I either have the power to make a flipped coin come up heads two times in a row OR I have the power to make it come up tails two times in a row, OR I can make the coin come up heads once and tails once."

Then you do the experiment, and I say

"See? I told you I had the power to make the coin come up [whatever combination it came up as]"

It doesn't seem right to me. They shouldn't be allowed to keep changing around their measurements.

[Crow]

Shire Lends Support to World Rare Disease Day 2011

http://multivu.prnewswire.com/mnr/prne/shire/47608/

LOL

[Birdlady]

From one of the articles,

Last December, the U.S. health regulator told the company that it does not need further efficacy studies for the drug and could file for approval based on the combined data from its completed late-stage studies -- 301 and 302 -- in 2011. [iD:nSGE6BJ08R]

Right here shows you the way drugs are approved in this country is a joke. First they can change what the original hypothesis says and any other studies that show their drug isn't working, don't even have to be submitted to the FDA! WHAT? It is no wonder many drugs which are dangerous slip through the cracks. Also why many drugs that actually do nothing, but cause side effects slip through as well. They are allowed to do anything they want apparently

I don't take midodrine because it did not help me, but I am curious to see what happens with all of this. You certainly don't want an ineffective drug taking midodrine's place if they do decide to stop producing it.