Keep me posted...


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Pilot Trials in Obstructive Sleep Apnea Completed
Results Do Not Support Continuation of Development Program
SAN DIEGO, CA -- (MARKET WIRE) -- June 27, 2006 -- Cypress Bioscience Inc. announced today that results of recently completed Phase IIa trials do not support continuing a development program evaluating combinations of mirtazapine with another approved drug as potential pharmaceutical treatments for obstructive sleep apnea (OSA).

Cypress and Organon, the human healthcare business unit of Akzo Nobel, had each independently conducted Phase IIa trials that served as the basis for today's announcement. A previous independently conducted small preliminary investigator sponsored pilot trial found that mirtazapine was able to reduce the number of abnormal respiratory events over the course of the night by roughly fifty percent. However, those data were not replicated in the recently completed phase IIa trials.


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Ed,

To follow up on your post, here is the link and article about it, from Reuters:

Click here for link

Quote:

CORRECTED: Cypress stops development of sleep apnea treatment
Wed Jun 28, 2006 5:43pm ET

Corrects paragraph four to show that Cypress and Forest Laboratories Inc. are developing a separate drug called milnacipran for the treatment of fibromyalgia. Makes clear that mirtazapine and milnacipran are different drugs.

BOSTON (Reuters) - Cypress Bioscience Inc. said on Tuesday it is dropping development of its experimental drug to treat sleep apnea after it failed to prove effective in a clinical trial.

Cypress and Organon, a unit of Akzo Nobel, had each independently conducted mid-stage, or Phase II, trials evaluating combinations of the drug, mirtazapine, with another approved drug.

Sleep apnea is a common breathing disorder which affects 15 to 20 million people in the United States and is characterized by brief interruptions in breathing during sleep.



Cypress and a different partner -- Forest Laboratories Inc. -- are developing a separate drug called milnacipran for the treatment of fibromyalgia, a disorder characterized by pain in multiple parts of the body.

The drug failed to show a statistically significant benefit in a late-stage trial for fibromyalgia but the companies are continuing to study it for the disorder.

Milnacipran has been marketed outside of the United States since 1997 as an antidepressant.

Cypress and Organon are exploring other opportunities for collaboration, Cypress said.

(Additional reporting by Tuhin Kar in Bangalore)



© Reuters 2006. All Rights Reserved.

My first post here. Been with the CPAP for several years. Recently my pulmonologist prescribed another sleep study to check setttings. The result was a lighter setting, and so for about a month I've been exhausted, nodding at work during my low metabolic period in the afternoons (not great...I'm an editor).
He suggested Provigil. I readily filled the script for the magic pill (so I thought.)

Took it for three days. Yes, it is a mild "upper," but I was a bit too chatty with folks, by my standards, and it didn't really help. I stopped taking it but by then the itching and swelling were really coming on: swollen eyes and gibletized lips. Couldn't read but boy could I drool. The welts and hives I got used to in about a week, but by then the Prednisone had started to help. Although steroids are never much fun.

So beware the magic pills.

1: Sleep. 2007 Jan 1;30(1):35-41. Links
    Efficacy of mirtazapine in obstructive sleep apnea syndrome.

        * Carley DW,
        * Olopade C,
        * Ruigt GS,
        * Radulovacki M.

    Center for Narcolepsy, Sleep and Health Research, Department of Medical-Surgical Nursing, University of Illinois, M/C 719, Room 910, 40 South Wood Street, Chicago, IL 60612, USA. dwcarley@uic.edu

    STUDY OBJECTIVES: Decreased serotonergic facilitation of upper-airway motor neurons during sleep has been postulated as an important mechanism rendering the upper airway vulnerable to obstruction in patients with obstructive sleep apnea syndrome (OSA). Although serotonin reuptake inhibitors have been shown to produce modest reductions in the apnea-hypopnea index (AHI) during non-rapid eye movement (NREM) sleep, they have not been proven to be generally effective as treatments for OSA. Conversely, antagonists of type 3 (5-HT3) serotonin receptors effectively have been shown to reduce the frequency of central apneas during rapid eye movement (REM) sleep in a rodent model of sleep-related breathing disorder. We sought to determine whether mirtazapine, a mixed 5-HT2/5-HT3 antagonist that also promotes serotonin release in the brain would effectively reduce AHI during both NREM and REM sleep in patients with OSA. DESIGN: A randomized, double-blind, placebo-controlled, 3-way crossover study of mirtazapine in patients with OSA. SETTING: Laboratory studies were conducted in the Center for Sleep and Ventilatory Disorders at the University of Illinois Medical Center. PATIENTS: Seven adult men and 5 adult women with newly diagnosed (treatment-naive) and medically uncomplicated OSA were randomized into the study. INTERVENTIONS: Each subject self-administered oral medications 30 minutes before bedtime each night for 3 consecutive 7-day treatment periods. These treatments comprised (1) placebo, (2) 4.5 mg per day of mirtazapine, and (3) 15 mg per day of mirtazapine. The order of treatments was randomized for each subject, and orders were counterbalanced for the overall study. MEASUREMENTS AND RESULTS: Each subject charted his or her sleep-wake schedule throughout the study and completed the Stanford Sleepiness Scale every 2 hours during the seventh day of each treatment period. Subjects were studied by laboratory polysomnography on the seventh night of each treatment period. With respect to placebo treatment, 4.5 mg of mirtazapine significantly reduced the AHI in all sleep stages to 52%, with 11 of 12 subjects showing improvement over placebo; 15 mg of mirtazapine reduced the AHI to 46%, with 12 of 12 subjects showing improvement over placebo. Sleep fragmentation was reduced only by the higher dose of mirtazapine. Gross changes in sleep architecture were unremarkable. CONCLUSIONS: Daily administration of 4.5 to 15 mg of mirtazapine for 1 week reduces AHI by half in adult patients with OSA. This represents the largest and most consistent drug-treatment effect demonstrated to date in a controlled trial. These findings suggest the therapeutic potential of mixed-profile serotonergic drugs in OSA and provide support for future studies with related formulations. Mirtazapine also is associated with sedation and weight gain-2 negative side effects in patients with OSA. In view of the above, we do not recommend use of mirtazapine as a treatment for OSA.

    PMID: 17310863 [PubMed - in process]

its also associated with causing compulsive eating


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After reading some of the side effects these pills have I'll stay with my CPAP machine. The only side effect from it are some weird marks on my face from the mask. They usually go away after being up for an hour or so.


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for those with CENTRAL apnea, there are several meds which are being used in treatment.  Acetaszolamide (Diamox),  almitrine (Duxil),  medroxyprogesterone, and theophylline.  The last 2 have more side-effects though.


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mom to 25 yr old with severe developmental disabilities
who has chronic insomnia & severe central apnea, & mild cheyne-stokes breathing
AHI 57; began Diamox 09-11-08 and cpap 10-03-08
full-face mask & Resmed Vantage AutoSet @ 10 with EPR 3

sleepydave wrote:

The last two drugs under consideration for treatment of OSA are Mirtazapine (in a small study group, 12 people had their apnea index reduced by half) and a new form of Mirtazapine presently being investigated by Cypress and Organon.

Quote:

The collaborative program (currently in phase IIa) will involve an enantiomer of mirtazapine, ORG 4419, and combinations of mirtazapine with another approved drug to potentially augment efficacy and improve tolerability, with Organon and Cypress jointly selecting the best development candidate based upon various proof of concept trials performed independently by both companies. The companies will also share costs and final responsibility for clinical development activities.

sleepydave

mirtazapine AKA "Remeron," is an antidepressant. Its been on the market since the mid to late nineties and if you want to try it, you can easily get a prescription for it off label. I took it  in 1998 for severe depression and insomnia and its a great antidepressant IMO. It doesnt cause agitation or akathisia like SSRIs can cause.

Drug companies have been looking at Remeron/mirtazapine for years as a possible pill for sleep apnea. What Ive read is that Remeron's effects on the serotonin 3a receptor has some sort of effect  ameliorating sleep apnea.

My sleep is much better when I take Remeron as an antidepressant rather than Zoloft. Remeron doesnt interfere with slow wave sleep and  REM sleep like almost all other antidepressants do, I guess thats the reason my sleep is better on it than an SSRI. That being said however, I dont believe mirtazapine will ever be FDA approved for OSA because of one thing...it causes the worst weight gain of almost any drug there is. Compared to other antidepressants, Remeron will make you  fat as a pig super fast.

I tried going back on Remeron as my antidepressant in Fall 2007, less than two months after starting CPAP. I gained 20 lbs in about two months on mirtazapine. I  wont be going back to it because of the weight gain side effect.

Its sad because while it causes massive weight gain, I found it does dramatically improve sleep quality and found it to make my sleep "deeper" or more restorative.

These other  drugs that are being investigated for OSA  are basically just "me too" versions of Provigil. Just stimulants  to be used as an adjunctive or add on treatment to CPAP. The stimulant type meds will never  treat the underlying OSA, just help residual fatigue, cognition deficts and EDS caused by OSA.

Fred[/b]


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