NEWSBRIEF: The U.S. Patent Office has issued a new patent to Chelsea Therapeutics for its drug droxidopa as a fibromyalgia treatment, according to the company. The patent is based on positive results of previous trials and would give Chelsea exclusive rights to produce the drug for a certain period of time, if it receives FDA approval.
Chelsea says it is gearing up to start its second phase 2 trial of droxidopa and has enrolled 120 fibromyalgia patients. The company expects to release preliminary results by the end of 2011.
What is Droxidopa?
Droxidopa is a synthetic version of a substance your body uses to make the neurotransmitter/hormone norepinephrine. Norepinephrine performs several important functions, and your body also uses it to produce dopamine, another important neurotransmitter. Studies have shown that this drug can improve fatigue, weakness, concentration, and orthostatic hypotension (blood pressure drop upon standing, which causes dizziness) in several conditions.
The drug is not yet approved in the U.S. for any use. However, it is currently in phase 2 trials for chronic fatigue syndrome and phase 3 trials for orthostatic hypotension in Parkinson's disease.
Based on typical timelines for drug testing and approval, this drug could be on the market in 3 to 5 years, if current trials are successful.
More Information:
- Positive Results With Droxidopa for Fibromyalgia
- Droxidopa Investigated for Chronic Fatigue Syndrome
- Neurotransmitter Dysregulation in Fibromyalgia & Chronic Fatigue Syndrome
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How could someone get in on the clinical trials for this one? I’m game!
Im game too!
Count me in too!!
Absolutely, me too!
is this trial available in Canada?
Id like to join this trial!
RE: “this drug could be on the market in 3 to 5 years”
Why does everything related to these mierable diseases take so long? ME and FM are the movie Contagion, only in slow motion.
John,
Sadly, that’s just how long it takes drugs to get through trials and the approval process. I read recently that it takes an average of 15 years for drug companies to develop a new compound and get it onto the market.
Faster approval would be great, but we’ve seen the results of some drugs that were rushed — they’re among those that have been pulled off the market for killing people.
But yes, the wait is excruciating for the people who need help!
~Adrienne
LOL, everything in my life is in slow motion! Yeesh, the drug sounds awesome–hope it really works!
I am also game and I live in Ireland, (which may exclude me in any event). However, I cannot but do a bit of wishful thinking.
3-5 years! that’s a long time! how do find out to get in on this trial????
Five years seems like a lifetime.
Something is wrong if it takes that long for a drug that promising to become available! Los Angeles chronic fatigue But if it’s in Phase 3 trials for Parkinson’s, it may not be that far in the future that physicians can prescribe it “off-label” for Fibro.
It’s a waiting game and for most of us we have combined health related issues. It would be great to see if this new drug works, but I don’t think anything that is approved by the FDA, doesn’t have really bad side effects ! Will see…Comments welcomed! Have a blessed day!
I would love to be in a trial of this med. My blood pressure is so low and whenever I stand up after bending I almost black out so that in itself not counting the rest would be wonderful.
I wish it didn’t take so long for the approval although I know there is lots of red tape.
Would be great if it worked and was something that would work for me before I end up disabled by this or have seretonin syndrome or something from too many meds.
I will never do another clinical trail. The last one I did 4 years ago almost killed me and destroyed my liver!
Interesting. It would be interesting to get more info. on how exactly it works on the body and I wonder how it would affect those of us who has rather severe side effects to certain medicines.
Sign me up!
i get itchy aLLERGY EYES! AND FEEL LIKE I HAVE ONIONSIN MY EYES? NOT SO BAD THIS YEaRtoo much rain in pacific NW.Usually the pollen coats the cars so bad u have to take it to a car wash to get it off.
How do you get to to be in the trial for this one?Would love to check this one out????!!!!
Re Allergies, Sinus, itching etc. On the recommendation of my pharmacist & Ear,Nose Throat Specialist I use Paw Paw ointment in my nasal cavity. As spring has just started in Australia I use this daily and have found it a great help. I still get some discomfort from time to time but generally speaking it has helped enormously. Similiarly you can use good old Vaseline or as some-one else suggested KY Jelly. I guess it ‘coats’ the nasal cavity and prevents the pollens etc. from ‘taking hold’.
are there any new drugs being used in trials for the awful pain of fibromyalgia? i am on my last leg here. i cannot take this anymore. there has to be something better than dependence on narcotics and such to try and deal with horrible symptoms of FM. i live alone and simply cannot make it anymore. i get no SSI – i was a stay at home mom and am now divorced. PLEASE PLEASE PLEASE HELP ME!!!
If it is used in Japan or China why cant we get it here?
Isnt it used in Japan for many years now?
I am ready to take anything! I would love to talk to anyone who was in the study. Even if it gave you 40 percent pain reduction that is better than nothing. Especially if combined with safe other meds.
I take Cymbalta, an antidepressant, that has a norepinephrine reuptake inhibitor in it just like the new drug. It has helped me a great deal with Fibromyalgia pain and other symptoms.
-I’d love to be a drug trial, how do you qualify?
I have tried EVERYTHING on the market for FMS/CFS. Now I am on cheapest there is, Methadone and Savella. Still I am in excruciating pain. This new one doesn’t give me hope either. Did any of you who want to be in the clinical treatment read the side effects? Not too great if you ask me.
This is a lifestyle that has to be managed daily by choices and acceptance I believe. Some days you accept it and some days you don’t. Today I was one I had to accept it and deal with the pain.
I’d be willing to be ina clinical for fibro and/or Parkinson’s disease. I have been dx with both.
Thank u for posting this HOPEFUL, news. For 20 yrs now I pray and hope that ONE Day they will find something that works on people with fibro and I pray and HOPE that this drug is it.. I take Cymbolta, Cesamet, and Zopiclone at night but I also take vitamins every day. But for now we have to wait and see if it’s working,so I don’t mind waiding 3-5 years.. I have waided 20 yrs now or 25 yrs as my family would say… There is always HOPE for better and I strongly belive that Better is coming our way!!!!
There’s a HUGE second issue here..COST. I’m on Disability and have Humana RX, with Extra Help from Medicare. They have just dropped coverage of a drug they’ve been paying for over the last 5 yrs, generic Flexeril, Cyclobenzaprine. My mom has the same Humana RX coverage, but not Extra Help from Medicare. They have NOT canceled her coverage of the same drug. The Generic is not expensive, so I dont get it why they’ve dropped it. Anyway, even after approval, the odds are Medicare Part D will not cover this drug for many years and the out of pocket cost I’m sure will be tremendous. As someone also mentioned, there are a lot of people with multiple illnesses, one drug alone for therapy for another illness I have (Costs $48,000 for 48-weeks of TX)…no chance in heck I could afford that. Most Brand Name Drugs under new patents are often excluded by Medicare Part D coverage… That excludes a lot of people being able to afford it.
PS…Rumor has it, there has been $5 billion in cuts made to Medicare. The first time ever.
Try Baclofen. It is a non-narcotic muscle relaxer that has been around for a long time and comes in a generic. Hope that helps!
I will talk to my doctor about this new drug..I’m on Cymbolta and Cesamet…although I do think they help because I get up from bed every day but the pain is still there..Peace
ALWAYS ask for generic, they are so much cheaper and have stood up to 10 years of time . vioxx worked for y OA but it was brand name and did not test the time, instead it was harming peoples hearts and killed a few.The only new drug I would pay brand name price for is cymbalta.I have FM tramadol works the best and is non addictive. when taken with cymbalta the pain relief lasts a lot longer. so I have to take less tramadol.
Now if they would just make a sleeping pill that would work and not make me eat like on ambien does. I want to sleep, not get drowsie but have hunger win over sleep and just get fatter and fatter.
Me to even though in Australia.