New drug for OI will seek FDA approval this year

[urbantravels]

OK, that's a bad headline, a drug can't "seek" much of anything on its own. But anyhoo, the drug in question is droxidopa or L-DOPS, it's been mentioned by Dr. Peter Rowe as a widely used treatment for orthostatic intolerance in Japan and other countries, said to be well tolerated. The company that makes it will be presenting it to the FDA for approval later this year, per Bloomberg:

http://www.businessweek.com/ap/financialnews/D9MM7E2G0.htm

Chelsea Therapeutics will seek federal approval for its blood pressure drug, the company said Monday, sending shares jumping nearly 25 percent.

Northera is designed to treat neurogenic orthostatic hypotension, which is a drop in blood pressure. The product is Chelsea's lead drug candidate and the company does not yet have a product on the market.

Chelsea Therapeutics International Ltd. has previously said it hopes to launch the drug in early 2012. Meanwhile, the company will continue to study the drug as a potential treatment for neurogenic orthostatic hypotension from Parkinson's Disease.

Shares rose 98 cents to $4.96 in afternoon trading. The stock has traded between $1.94 and $8.20 over the last 52 weeks.

The active ingredient in Northera is droxidopa and Chelsea is also studying droxidopa as a treatment for fibromyalgia, a chronic disease that causes muscle pain and fatigue.

 

[leaves]

Nice!! Thanks !

 

[TinyT]

Sweet! Let's bring it to Australia!

 

[SpecialK82]

Great news - I know someone that was in the trials here in the US, she had severe OI and she said that it helped a great deal but that it made her extremely nauseated. She said about 25% of the people in that trial had this side effect.

I am excited this is coming to market - I think if we can tolerate standing, this illness would be much more tolerable.

 

[toddm1960]

I wonder overall what percentage of OI has hypotension or hypertension? It seems 95% of research is focused on hypotension, this drug is another example.