in the lower left-hand corner, there's a link to "download" the coupon. When you click on it, they want some information about you, undoubtedly so they can send you ads... when you fill that out and submit, then you get the coupon.
Fine print says: Offer limited up to one rebate at 12 uses per rebate per patient for the duration of the program. Offer good only in the USA and void where prohibited or otherwise restricted by law, or subject to state sales tax. Coupon not valid for prescriptions that may be reimbursed under a federal or state healthcare program, including Medicare, Medicaid, or any other similar federal or state healthcare program, including any state medical pharmaceutical assistance program. Coupon void in Massachusetts, except for cash-paying patients.
Guy, thanks for the launch date info. I was too cross-eyed after reading the prescription info to see anything else!
guy, I thought it was not going to be available until March 2nd. Let us know if we can actually get it now. I'm also interested in how much it will cost.
Dazed, Yes I'd love to know how much it costs. I don't think I will get it now, I looked up AXONA to see if my pharmacy has it and they didn't. What I think I will do is drop off the script and tell them to call me, email or send me a smoke signal to let me know what it becomes available.
Well, Guy, I trust you've got your 20% off coupon! I thought I was going to be able to talk to my husband's doctor today, at our appointment ... but he had a medical emergency and had to reschedule. Another two weeks. Ah, well, I've got plenty of MCT Fuel, anyway...
I read on the other site that Medicare Advantage plans will not cover Axona. We have a different prescription coverage so I checked to see if our insurance will pay. We order a 90 day supply and they said a 90 day supply would be $228.42. Our insurance will pay $190.35 and our co-pay will only be $38.07 for 90 packets of the powder. It's in their data base but they don't actually have it yet. I'm contacting DH's doctor on Monday to get a prescription.
Imohr, I don't know about Medicare Part D but since the Medicare Advantage Plan doesn't cover it, Medicare Part D may not either. I'm not sure about the difference in these plans. You'll probably have to check. We need Jane...bet she'd know. I don't understand why any insurance would refuse to pay since definite improvement was shown in the clinical trials. The other drugs for AD only claim to slow the disease. GuitarGuy, did you mention in yor email to the insurance company about clinical trials and the improvement rate with Axona?
With the mail-in 90 day prescriptions, coupons are not accepted.
I imagine that the individual insurance companies will decide whether Axona is covered. Medicare Part D is not a Government program per se, the way Medicare Parts A and B are. Instead, each insurance company gets to establish its own formulary and tier set-up.
Dazed, the Government set up the basic rules for Medicare Part D, but you actually buy the policies from private insurance companies. For example, my husband gets his Medicare Part D drug coverage through Humana.
The groundrules do not stipulate which meds have to be covered -- different insurance companies cover different meds. That's why it's such a good thing that the government set up a web-based tool for comparing the different policies. You can enter the meds your husband is currently taking (how much and how often for each) and the tool will calculate for you the total costs for the year -- premiums, co-pay, donut hole combined -- for every policy that is offered in your area. You can sort by cost to find the least expensive overall, you can get information on the insurance company, etc.
just got back from our neuros appt a bit ago. says he was elated DH looks so well this time...hahaa..i said yeah at my expense!" -i told him he keeps me on my toes with his hooliganisms:) i told him about Axona and he is willing to allow us to try it out after its on the market in march. but i had to take DH in to the lab before we left and do full blood work as dr wants to have the befores and afters if i decide to try it. says its important to compare labs after being on it just to be sure things are going ok. everyone can respond differently of course and the liver, kidneys, heart, all organs need to be followed during useage of this new drug. well at least i was 'validated' as my role as poop queen this round..:) i must be doing something right! couldnt believe DH actually followed the drs commands this time! coconut oil anyone??::))divvi
When I picked up my wife's prescriptions today the pharmacist told me that he had already received Axona, so I plan to get a prescription and give it a try.
A while back I took a page out of Sunshyne's book and called Dr. Henderson re Axona. He said the physicians will be given samples, just like all the drug cos. do. So ask your doctor if he has or can get samples before you buy it.
I just received this e-mail about today's launch of Axona - joang
Good morning,
Based on your connection to Alzheimer's disease, I thought you might be interested to know that Axona was launched today. Axona is a first-in-class medical food for the clinical dietary management of the metabolic processes associated with mild-to-moderate AD. Available by prescription, Axona provides an alternative energy source for the brain so that neurons can function properly and patients can improve cognition. Below is a release with more information. Please let me know if you have questions.We would love your help spreading the word about this new treatment to your readers, many of which may be in search of promising new therapies.
Thanks,
Alicia
Alicia Atalla-Mei Assistant Account Executive a: 2001 The Embarcadero , San Francisco, CA 94133 USA o: 415.293.2824 e: alicia.atalla-mei@mslworldwide.com w: mslworldwide.com
******************************************************************************************************************************************************************* Accera Launches Axona TM , First Medical Food Therapy to Help Manage Mild-to-Moderate Alzheimer’s Disease
Broomfield, CO, March 2, 2009 – Accera, Inc., a biotechnology company delivering breakthrough therapies in central nervous system (CNS) diseases, today launched Axona TM in the United States for Alzheimer’s disease (AD). Axona is a first-in-class medical food for the clinical dietary management of the metabolic processes associated with mild-to-moderate Alzheimer’s. Dispensed by prescription, it targets the metabolic deficiencies and imbalances associated with AD by providing an alternative energy source for brain cells.
Axona represents a new approach to helping manage AD symptoms and has been shown in clinical trials to safely improve cognitive function and memory in patients diagnosed with mild-to-moderate AD.
“We are happy to have this new therapeutic approach to add to our management strategies for this terrible disease,” said Jeffrey L. Cummings, M.D., Director, Mary S. Easton Center for Alzheimer’s Disease Research at UCLA, and a consultant to Accera. “By approaching the disease in a new way, Axona addresses a metabolic abnormality of Alzheimer's disease that has not previously been examined. The goal of therapy is to optimize cognitive function. Axona is safe and can be used with other common therapies for Alzheimer’s.”
Alzheimer’s disease is a progressive and fatal neurological disease characterized by a substantial decrease in the brain’s ability to metabolize glucose, which is the brain’s primary source of energy. Known as hypometabolism, this defect may contribute to both the clinical and pathological course of the disease. Axona targets the metabolic defects of glucose utilization in the brain by providing an alternative energy source. Axona is digested and metabolized by the liver to form ketone bodies, naturally occurring compounds produced by the body at low levels. These ketone bodies act as a secondary energy source for the brain to help maintain and improve cognitive function.
“It’s a novel and effective approach to Alzheimer’s disease,” said Steve Orndorff, Ph.D., founder and CEO, Accera, Inc. “Similar to how insulin helps diabetics, Axona supplements energy for the brain so that neurons can continue to function properly and patients can maintain cognition. As a company focused on developing new therapies for central nervous system disorders, we’re very excited about Axona’s potential to help the AD community.”
Axona was evaluated in a double-blind, randomized, placebo-controlled study performed at multiple U.S. clinical centers in a population of 152 patients with probable mild-to-moderate Alzheimer’s disease. Patients taking Axona demonstrated significant improvements in cognitive function by day 45 (as measured by the Alzheimer’s Disease Assessment Scale-Cognitive subscale or ADAS-Cog score). These patients also maintained a slight improvement from baseline after 90 days of daily Axona administration, whereas the placebo group demonstrated a decline. In these trials Axona was demonstrated to be safe, effective and generally well-tolerated. Continued below -
Axona is supplied as a powder formulation in individual packets. Contents should be mixed with water and consumed at breakfast. With simple administration and once-a-day convenience, Axona is complementary to current Alzheimer’s therapies.
About Alzheimer’s Disease AD, the most common form of dementia, is a progressive and fatal disease for which there is no cure. It attacks the brain's nerve cells, resulting in loss of memory, executive function, thinking and language skills. According to recent data, every 71 seconds someone in America develops AD.
In the U.S., 5.2 million people are living with AD, and it has become the sixth leading cause of death. These numbers are expected to increase as the baby boomer generation ages and as medical technology continues to advance. In fact, it is estimated that 10 million U.S. baby boomers alive today will develop Alzheimer’s disease. With the lack of innovative new medications, both patients and caregivers are seeking alternative therapies to improve quality of life.
About Medical Foods A Medical Food is an FDA-regulated product, in a relatively new category of medical protocols defined by Congress as part of the Orphan Drug Act. A Medical Food is formulated to be consumed or administered orally under the supervision of a physician and is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. Medical Foods are often prescription products, but are different than drugs or dietary supplements (also called “nutraceuticals”) in several aspects, such as their claims. Claims for both Medical Foods and drugs must be supported by solid laboratory and clinical data. Medical Food ingredients have Generally Recognized As Safe (GRAS) designation, the highest FDA standard of safety given to foods. Medical Foods, sometimes prescribed in addition to drugs, represent an entirely different scientific and medical approach to managing diseases. # #
About Accera, Inc. Accera, Inc., a privately held biotechnology company, discovers and develops product breakthroughs in treating central nervous system disorders. Accera’s novel therapeutic approaches positively impact patients with neurodegenerative disorders, who are in need of effective, well-tolerated treatments. Through its proprietary scientific platform, Accera is developing therapies that address metabolic deficiencies by providing an alternative energy source to the brain. For more information, visit www.accerapharma.com .
Contacts Media: Investors: Kelley Carpiac Cecelia Heer MS&L Worldwide Richard Lewis Communications Ph: (323) 866-6003 Ph: (212) 827-0020 kelley.carpiac@mslworldwide.com cheer@rlcinc.com
Alicia Atalla-Mei Assistant Account Executive a: 2001 The Embarcadero , San Francisco, CA 94133 USA o: 415.293.2824 e: alicia.atalla-mei@mslworldwide.com w: mslworldwide.com
Ok, now, guys. Those of you who have been treating your spouses for a while with the coconut oil or whatever.. has it really helped at this point? Can you look back and say yes, the changes have been significant? Divvi, has the pooping inappropriately (to say the least) stopped? Are the spouses who didn't speak, now speaking? Seeming more rational?
He's alert---the vacant look is gone. He initiates conversations with others---including strangers, checkouts, etc. He wants to do things rather than just sit--go for walks, go to the mall, etc. I was just thinking this morning that he hasn't been asking repetitive questions. Some things change gradually and until you stop to think about it, you're not aware of the changes.
Yes, it has helped in our situation. Not across the board but little things. More alert, initiates conversations more with others--including strangers, checkouts, etc. , Not as much repetitive questions, signature improved, similar to Lori2. Can put on and tie shoes, take own shower. But there are times during the day when he reverts back but overall I plan to continue the coconut oil or accura. My Neuro wants to see information so I printed some off for him and intend to drop it off to him today.
I am wondering if I discard the coconut oil if I give the accura?
Sunshyne, If I had known your real name, would have told Dr. Henderson you said hi. Didn't know what he would think if I said "Sunshyne sends her regards"! He is an physician, right? I don't think (pardon me Marsh and any other physicians reading this) that most medical doctors are known for a sense of humor. He sounded very nice, though, and a little surprised to hear from me.
I have had DW on MCT for a while (we are on our second bottle). So far I don't see any real change. Maybe she has APOE4. I'll see if I can have her tested.
Well i did see small changes for the better with reg small dose of coconut oil. MCT oil gave my DH the runs super bad with just 2 tablespoons. didnt try again. our neuro is game for the axona but i said i would like samples if he gets them first. he said he would want to 'wait' and not be the guniea pig til others try and we see how they do:) plus lab works prior and after short use to see. DH was recognising some colors and reading some signs as we drive which he didnt do anymore and seems like in better alert mode like imohr says. nothing out of this world but we live with them 24/7 we notice the little things. poop is off/on depending. i just dropped off a pee specimen finally!! after tagging him all morning for one. i am pretty sure he has a dread uti. all the signs. waiting for dr to call us back after lab results today. so poop was there before and after and DH has always been like that only did his own bathroom issues by himself. i am thinking hes had uti for a bit now and with his daily dose of antiobiotics its kept it at bay some but now its fullblown. that makes a huge difference in his cognitiive and ADL habits when hes sick/ so in answer, yes i will continue the coco oil..his bllood work came back ok so colesterol is ok for now. Divvi will try axona further down the road=
My husband is definitely improved in the last month--he gets more done. I don't know if he is rising to the challenge of helping his 97 year old aunt or whether it is the 2 large teasp MCT oil and 1 of coconut oil per day. We talked about Axona and decided tentatively to stay with the MCT oil, on the theory that it is cheaper and almost surely tastes better.
divvi, there's a lot more MCT per tablespoon in MCT oil than there is in coconut oil. 2 Tbsp is a pretty big dose of MCT oil.
The original clinical trial was done with 14g of caprylic acid, which is roughly equivalent to:
5 Tablespoons (15 teaspoons) of MCT Fuel (the orange-flavored emulsion)
2.25 Tablespoons (~7 teaspoons) of coconut oil*
1.5 Tablespoons (4.25 teaspoons) of MCT oil
The final formulation of Axona contains 20g.
Sharan: MCT oil is roughly 2/3 caprylic acid and 1/3 capric acid. Both are medium-chain triglycerides, and their absorption/digestion/metabolism profiles should be similar. Caprylic acid is the active ingredient in Axona. Axona also has other constituents, designed to (a) minimize/avoid gastrointestinal problems,(b) make the caprylic acid more effective, and (c) make it taste good...!
MCT oil is sold by many health food stores. It comes as just oil (which is tasteless) or in an emulsified form (MCT Fuel by Twinlabs) which is sort of orange-flavored. Emulsification makes it easier to absorb/digest and so you have better control of the actual dose your ADLO receives. (Axona is emulsified.)
The MCT oils or coconut oil can cause cramps and diarrhea unless you start out slowly.
We are on MCT oil only (straight and emulsified). Coconut oil just has too much bad stuff in it, IMHO. Husband is more alert, talks more easily, actually looks for chores to do from time to time (he cleaned the bathtub without prompting the other day!!!) When he had been on it just for three weeks, he had an appointment with his neuro, and did surprisingly well on the testing (an extended MMSE, took about 1.5 hours.)
Sunshyne -Why wouldn't it be suitable to just continue with the MCT oil instead of the accura, due to hugh price difference? I show the same improvements you do. Question being - my dh meds are all the expensive ones and keeping costs down is pretty important here. We have shown NO bad side effects from the MCT or coconut oil. I try to substitute the MCT or coconut oil for his butter so usually we have a exchange of oil instead of adding new ones.
lmohr, the caprylic acid is the "best of the best". Between that and the other constituents in Axona, the Axona is quite likely to be a bit more effective.
Plus the quality control during manufacture is likely to be MUCH greater for the Axona. As a medical food, it has to be produced under very stringent conditions. That might become very important for our loved ones who are developing lots of other medical conditions.
But if you're in financial difficulties and just plain can't afford the Axona, I imagine the MCT oil would serve as a reasonable substitute. Certainly much better than going without entirely!
Alzheimer's Daily News announced the launch of Axona, with a link to this page:
http://www.prnewswire.com/mnr/axona/36444/
Not much new, except there are links to a couple of new papers I hadn't seen before ... those of you who are fond of reading the literature might be interested.
I know I asked this before under the coconut oil thread, but received no response. Now Foods has Caprylic acid tablets. Have you checked to see if they appear to be any good?
I just called the Axona folks and they said if you have a prescription you can take it to the pharmacy and they will order it. It should take about 24 hours. So that is what I will do today.
She asked me how I heard about the product and I gave her a short history of what we've all been doing. :>)
How Does FDA Oversee Medical Foods? Until recently, medical foods received little attention. But the number and types of foods marketed as medical foods are increasing. While FDA is working to more clearly define and regulate medical foods, specific requirements for the safety or appropriate use of medical foods have not yet been established. Medical foods do not have to include nutrition information on their labels, and their claims do not need to meet specific standards
I was confused about just what a medical food was so I downloaded the above
bluedaze, what you read was misleading. Medical foods, by definition, are comprised of constituents which have GRAS status (generally recognized as safe) so safety is established. There also has to be a substantial body of scientific and clinical data that demonstrates the efficacy of the medical food for treating a specific disease. And there is a humongous compliance program document (detailing all the quality assurance / quality control mechanisms that have to be followed during their manufacture), just finalized in June of last year.
What has not yet been established is a formal protocol for applying for and receiving FDA approval.
The requirements for medical foods has been changing. In 1996, the FDA published an advanced notice of proposed rulemaking, which stated that medical foods are not meant to be used by the general public and may not be made available in stores or supermarkets. Medical foods are specifically intended for use under the supervision of a doctor, and the FDA believed that, if medical foods were available over the counter, consumers who were not under the supervision of a physician would use them. Further, the FDA believed that Congress intended medical foods to comprise a narrower category of foods for people with particular diseases or conditions who have distinctive nutritional requirements, and that pre-approval should be required to ensure that they are indeed safe and effective for those patients.
However, the FDA did not finalize its proposed rulemaking. This created a very interesting "gray area" in the law.
Ever since the advance notice was published, many manufacturers have been reluctant to enter the medical foods market because of the lack of definitive regulations. Manufacturers do not want to risk investing their time and money developing and marketing a medical food only to have the FDA issue final rules that could eliminate products from the market.
On the other hand, other manufacturers saw the lack of regulations as an opportunity to market products without FDA interference ... getting away with calling something a medical food when, in fact, it does not fit the FDA definition.
The longer the FDA went without formally implementing the new rules, the more manufacturers began to sell products in stores as "medical foods", thinking they could act with impunity. They are making claims about the health benefits of certain products -- specific claims that the products will help treat a disease -- which is clearly against the intent of the proposed rulemaking notice. Sooner or later, the FDA will crack down on them. The FDA already has the authority to do so.
Other organizations, such as Accera, have complied with the proposed rulemaking notice, without waiting for it to be formally adopted, to make sure they meet FDA requirements even before they are actually required to.
Charlotte, I hadn't seen those before. My only concern would be whether the gels dissolve readily and the caprylic acid would be easy to absorb. I don't know why it wouldn't be, mind you, I just don't know whether that's been tested. I assume it has.
Plus, at 1g per gel, you'd have to take 20 of them for a daily dose.
But it's a nice option to have, for those times when we're not going to be in a position to administer a liquid for some reason. I think I'll get some. Thanks.
Sunshyne I had an interesting experience last night. I attended a presentation put on by a large health food chain. This is the program: TONY DeANGELIS Clinical Nutritionist Has advanced degrees in Engineering and Nutrition Registered dietitian 20+Years experience in Clinical Nutrition Has written 900 page,unpublished, nutrition reference manual Was host of West Palm Beach radio show for one year Was president of a cancer victors group for 2 years Numerous published health articles for local papers Currently writing a self-help manual for laypersons wishing to take charge of their health experience. Now comes the scary part. He totally trashed the FDA. Advised the audience to stop taking their statins and osteoporosis meds. Claimed milk was the cause of osteoporosis and to stop taking calcium supplements. I am ashamed of myself for not challenging him but I didn't want to embarrass the store owner. I did tell her how I felt and she didn't dispute me. Point of this post-research for yourself what the "experts" tell you. This is a good reason why we keep your around. Your research is totally sound. Thank you
Bluedaze, it's a good thing you kept your mouth shut. Anyone with any sense would have reacted as you did. The rest would have gotten upset with you, you would have gotten all stressed out, and you wouldn't have managed to do any good, anyway.
Periodically, we have a quack like that pop up on the Alz Assoc discussion forums. The caregivers who want to believe do, no matter what. Drives me bonkers. Sometimes I say something, sometimes I just throw up my hands and hope they don't influence other caregivers to do something really dumb. Fortunately, over there, sooner or later the quack steps over the line and starts actually trying to sell something (like a 900 page, unpublished, nutrition reference manual ... love it!) and then Admin lands on them, because that's against the rules.
Sunshyne, I'm glad I found you over here....I need your input. DH's neurologist does not approve of my giving him the MCT Fuel due to plaque build up in his arteries. Instead she wants him on Neurostin. He had improvement in the past two weeks on the MCT and he told her that he would try this new "stuff" but that his mental health was as important as his physical health!! (I posted this on a separate thread here and I'm repeating myself, but I was so proud of him!) A couple of weeks ago he would not have been able to put all those thoughts together.....and forcefully, I might add!! So, he will try the new "stuff" and we'll see. Do you have any thoughts on the caprylic acid as an addition? I suppose I should just follow her advice and give it a try, but he is doing so well and I'm so afraid this will not be as good...
The neuro is wrong about the MCT Fuel posing a cardiovascular health problem. She is having a knee-jerk reaction to the words "triglyceride" and/or "saturated fat".
Both of the MCTs in MCT Fuel are considered to be "neutral" with regard to having any impact on cardiovascular risk factors. In fact, the FDA has granted caprylic acid "generally recognized as safe (GRAS)" status, which is rarely granted. (I need to see if capric acid has that status, too ... it is metabolized pretty much the same way.)
I would need to look at Neurostin a little more closely, but first blush, I did not see anything there that has been shown in clinical trials to improve cognitive function in AD patients. Caprylic acid, on the other hand, has been.
I also didn't see anything that looked incompatible with MCT Fuel, at first blush, but let me dig a bit deeper. Right now, I've gotta go feed my husband! I look into it more in the morning.
Thanks, Sunshyne, my first thought was you! I think you're right on the "knee-jerk" reaction. Same as the reaction when I tell them about DH's problems with statin drugs. I KNOW the MCT Fuel has helped him. He has 3 T. each day and I can see the difference.