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Montelukast's (Singulair) unexpected benefits
Larrytherunner
Posted: Thursday, April 12, 2018 3:53 AM
Joined: 2/26/2016
Posts: 243


I am 70 years old now, and I have been taking the anti-inflammatory drug montelukast for over 2 years , and I have been posting the results on this board. Within a week after I started taking this drug, my extreme mental fatigue and occasional confusion disappeared, and I was completely back to normal.

 

I have discovered some added and unexpected benefits that I would like to mention:

 

Benign prostate enlargement. Before taking this drug, I had been experiencing symptoms of this condition which is often seen in older men. I had difficulty urinating, and I was taking several medications which did not work and which I discontinued. After taking montelukast for about 3 months, the symptoms started to go away. For the last year and a half, I have been symptom free. It makes sense because inflammation is a probable cause of this condition, and the prostate contains luekotriene producing mast cells and luekotriene receptors. Montelukast blocks inflammation causing luekotrienes from entering cells with luekotriene receptors.

 

Muscle aches due to exercise. I started running daily more than 55 years ago when I joined my high school track team, and I continued to run on the track team in college. I have continued to run daily up till now. About 3 years ago, I thought I was going to have to give up jogging and start walking because my legs were giving me so much pain. After I started taking montelukast, the muscle pains went away. Again muscle also contain mast cells producing leukotrienes and also leukotriene receptors. I am still running about 2 miles every morning morning. The muscle pains in my legs are gone and I feel like 20 years younger when I run. 

 

Better sleep. I have mentioned this before in my posts. Before taking montelukast, I couldn't sleep very soundly and I was feeling sleep deprived. I also rarely had dreams. After taking the drug, I sleep much more soundly and often have dreams, and I feel much more rested. Evidently reducing brain inflammation can improve sleep.

 

You might ask, if montelukast is a widely prescribed drug for the prevention of asthma attacks, why haven't people noticed its beneficial effects on other conditions. One reason is that the recommended adult dosage for asthma is very low - only 10 mg once a day. I myself am taking 40 mg (20 mg twice a day). Since the drug has to cross the blood brain barrier to treat Alzheimer's and dementia, 10 mg a day is probably not enough to make much difference. Other conditions may also require higher than 10 mg a day. So people taking the low dosage may not see much change in other conditions.

 

A reason that montelukast is not being considered for repurposing is that big pharma is not interested in paying for clinical trials for inexpensive off patent drugs. There is a lot of repurposing trials going on right now, but they are for high priced on-patent drugs and high priced biologics and cancer drugs.

 

Still there a small drug company in Canada, Intelgenx, run by research scientists (not finance people) that is sponsoring a clinical trial on montelukast for Alzheimer's and dementia under the supervision of the Canadian government. Hopefully we should get a progress report before the end of the year. When this drug becomes more widely prescribed in higher doses, then we will find out more about its anti-inflammatory uses and how it can treat other medical conditions and even slow down the aging process. 

 

I predict that montelukast and other leukotriene blocking drugs will eventually become as common as statins in preventing diseases. Big pharma may not be interested in these drugs because the big money is not there, but once montelukast becomes the standard for Alzheimer's and dementia treatment, governments around the world will begin looking into doing clinical trials for leukotriene blocking drugs for other diseases.


Serenoa
Posted: Thursday, May 10, 2018 3:47 AM
Joined: 4/24/2012
Posts: 484


This is great information. Glad you're doing well and that you are keeping us updated on your experience with Monteleukast.
Larrytherunner
Posted: Saturday, May 12, 2018 12:42 PM
Joined: 2/26/2016
Posts: 243


Thanks, Serenoa. I am sure that you have noticed recently that there are a lot of research articles coming out that identify inflammation as a main cause of Alzheimer's and dementia. I think that from my own experience that leukotriene blocking drugs like montelukast (Singulair) will prove to be effective treatments. We will see when we get some results of the montelukast trials at the end of 2018 or beginning of 2019 in Canada.
Iris L.
Posted: Saturday, May 12, 2018 9:50 PM
Joined: 12/15/2011
Posts: 17587


Thank you for the thorough update, Larry.  When I broached the subject with my neurologist, he was not interested, saying that results were inconclusive.  I am interested in the Canadian results.  

Iris L


markus8174
Posted: Tuesday, May 15, 2018 10:30 AM
Joined: 1/25/2018
Posts: 712


Iris L. wrote:

Thank you for the thorough update, Larry.  When I broached the subject with my neurologist, he was not interested, saying that results were inconclusive.  I am interested in the Canadian results.  

Iris L

This response, although very common, makes me crazy! "We don't have any conclusive proof this treatment will be of any benefit" AAAUUGHHH! There are few side effects to this medication, it has been proven safe at much higher doses than the usual 10mg/day, and it may help! What is wrong with trying it. At worst, it will do nothing for the AD. If there are intolerable side effects- stop the drug- you are no worse off than before. It's cheep compared to many of the other drugs used in the treatment of AD. And lastly it may be THERAPUTIC, not just palliative like Namenda and Aricept who do nothing to stop the illness. They just mask the symptoms until they can't, and your loved ones takes the fast slide down the rabbit hole. My doctor was willing to prescribe the 10mg/day- no higher. I guess I'm thankful for that crumb, but my DW is too far gone for me to take a trip to Mexico to pick up a supply without a US prescription. There is no one to stay with her for even a few days, and airfare, hotel, finding a pharmacy willing to sell, getting back through customs, renewing my passport....the cost of the drug, with these added, gets very high for a few unconfirmed reports of improvement. I just wish our doctors would recognize that a small chance of improvement beats no chance at all. (Especially with such a low risk medication.) 

Larrytherunner
Posted: Thursday, May 17, 2018 6:44 AM
Joined: 2/26/2016
Posts: 243


Iris, I am not surprised that your neurologist won't prescribe it. I have received a number of replies to some of my posts and it is the same story. I feel lucky that I am now living in a country where I don't have to have a prescription.

 

About the time that the patent for Singulair was about to expire, Merck applied to the FDA for over-the-counter status. Even though it had a very good safety record, it was turned down mainly because the FDA board was concerned that consumers would mistakenly think it is a rescue medication for asthma attacks, where as it is supposed to be used to prevent or reduce the number of attacks. I think that if it had become over-the-counter, it would have become widely used today for Alzheimer's and other conditions as word got around.

 

I think it is necessary to look at the neurologist's situation. Many of his/her patients take a lot of drugs with possible serious side effects, and many patients are not in good health. What happens if a patient has a serious medical emergency and the patient or relatives are seeking to blame the doctor? When a patient is taking a lot of drugs, in most cases, it is difficult to pin the cause on a particular drug with certainty. So what the lawyers often do is look into the patient's prescription history and look for some action that is not generally accepted. A neurologist has only a very limited number of drugs that he/she can prescribe off label that are generally accepted as a treatment for the symptoms related to Alzheimer's and dementia. If the neurologist strays from that list, he/she is taking a big legal risk. It is possible that the medical group that the neurologist belongs to has a policy not to write prescriptions for off label drug treatments that are not generally accepted. Malpractice insurance companies may also have counselled them against this practice.

 

I think that you might be better off seeing a GP or internist. They would be more familiar with this drug, and they would likely know how it works and its safety record. Still, a lot has to do with the personality of the physician, and also the group he/she belongs to. In the case of Dr Rozin, he was running a study on the drug, and no doubt, the patients or legal guardians had to sign papers informing them of the risks, so he was legally covered. 

 

If the early results of the clinical trial in Canada turn out to be positive, it might be better to go to a physician who is not a neurologist. It may take years to complete the trial and still more years for neurologists to start prescribing it because is not being marketed by a big pharma company with lots of money for advertising and for lobbying doctors.

 

Iris, thanks a lot for your interest. I will keep you informed about the trials.


Larrytherunner
Posted: Thursday, May 17, 2018 10:12 AM
Joined: 2/26/2016
Posts: 243


Markus, I agree with you one hundred percent. Why shouldn't your wife be able to try a drug as safe and commonly used as montelukast (Singulair).

Going to Mexico might not be the best way, unless you live near the border and can drive across. Even if you can buy the drug there, you might get stopped at the border coming back and have your drugs confiscated. I don't know if they would recognize a prescription from a Mexican doctor. 

Why not do your own clinical trial? Get a prescription for 3 months (12 weeks) and let her take 2 X 10mg twice a day for 3 weeks. From my experience with this anti-inflammatory drug, I got full benefit after only one week. It works amazingly fast. 

If it works for her, you will need to get prescriptions from 3 more doctors (for reduction of asthma attacks) to maintain the 40mg a day level. This drug is so common that I doubt any doctor is going to question your intent. You can say that you have previously taken it and want to start back again. Since there is really no common test for asthma, they will take your word for it. And don't go to a neurologist. Go to a GP, family physician, internist, etc.

I know that you don't like doing it this way, but it is the only practical way I can think of, unless you want to move overseas. I hear Costa Rica is really nice.

Good luck, Markus


Iris L.
Posted: Friday, May 18, 2018 12:15 AM
Joined: 12/15/2011
Posts: 17587


Markus, I am a patient myself, with a diagnosis of cognitive impairment nos.  I am on Exelon patch and Namenda XR since 2009.  Markus and Larry, I was a physician in my career life.  I know all about the legalities of prescribing medications.  No doctor would prescribe a medication for asthma without seeing signs of asthma.  At least, not in California, the most litigious state.  But I'm glad you reminded me.  Tijuana is just down the road, two hours away.  I'll keep that in mind.


Iris L.


CathieJ
Posted: Tuesday, June 19, 2018 12:32 AM
Joined: 3/2/2018
Posts: 2


I just joined this site and noted interesting information from users regarding Montelukast. I am the caretaker and wife of a husband who is suspected to have FTD. In the past, I have taken this (Singulair) prescribed for my asthma, and am confident in its safety.

We are scheduled to see his pulmonary doctor pertaining to sleep apnea Thursday. I hope to run this information by the doctor, in hopes he will consider a trial dose for some period. Because it would be for off label use, I am not overly confident in a positive response.

Does anyone have any suggestion asto how to handle approaching this doctor? If one cannot get their doctor to agree to this, I suppose the only other way to get this is to go to Mexico or Canada, assuming it is possible to buy it there.

I would appreciate any suggestions members here might be willing to offer.

Thank you.

 


Larrytherunner
Posted: Tuesday, June 19, 2018 10:43 AM
Joined: 2/26/2016
Posts: 243


As you have read, I have been taking montelukast (Singulair) for over two years, and I am completely back to normal after being diagnosed by doctors in Ghana as having dementia due to aging. I discovered this drug during my internet research, and it is the only drug I have taken for this condition. Back then you could only find animal research experiments for treating dementia with montelukast, but now there is a clinical trial under way under the supervision of the Canadian government.

You can ask your pulmonary doctor for a prescription, but the chances of getting one for your husband are slim. You might ask for one for your self, since you have had asthma. 

I would suggest that you get a prescription from a GP or family practice physician, perhaps outside your medical group. Get a three month prescription or more. Normally for asthma, the standard dosage is 10 mg per day. I don't know why Merck picked such a low dosage, but just about every anti-inflammatory drug requires at least twice a day dosage unless it is a time-release capsule.

Have him take 10 mg twice a day for about two weeks and see how he feels and if there is any improvement.

In the beginning, I took 10 mg once a day and it only worked for about half of a 24 hour day. I switched to 10 mg twice a day, and I was feeling normal again for the entire 24 hour day. I switched to 20 mg twice a day when I was able to get the generic here in Ghana. My extreme mental fatigue is completely gone and I sleep much better, and there are other benefits that I have already mentioned. 

You have a big advantage in that you have had asthma and can get a prescription. If you find that your husband is benefiting, you can see a second doctor to get another 10 mg a day, making 10 mg twice a day. Thanks and good luck.


baystate
Posted: Thursday, July 26, 2018 10:35 PM
Joined: 1/25/2017
Posts: 3


you could always buy online w/o a prescription fro druggist in India
xiaofeng
Posted: Thursday, October 25, 2018 2:04 PM
Joined: 9/12/2018
Posts: 61


baystate wrote:
you could always buy online w/o a prescription fro druggist in India

my friend in Japan did. but I have yet to see one that ships to USA. or even better for me , China. I guess there is a risk of authenticity. 


Larrytherunner
Posted: Saturday, October 27, 2018 11:56 AM
Joined: 2/26/2016
Posts: 243


Xiaofeng. I am sure that your father will have no problem getting montelukast in China. This is a very common drug available all over the world. Last time I checked, there were more than twenty manufacturers of this drug, with some located in China. This is one reason it is so cheap.

The problem in America is that the drug is not FDA approved for Alzheimer's and it is not supported by a major pharmaceutical company for off label use. Therefore American physicians are reluctant to prescribe it for Alzheimer's.

Your father is living in China so there is no reason to buy it from India and ship it to the US. The shipping would be costly and it would likely be seized by US customs if there is no accompanying prescription.   

Since your father is living in China, I am sure your family over there would have no problem getting montelukast for him. He can go to a private doctor if he wants. Perhaps you can write a letter addressed to a doctor saying that montelukast is in clinical trials in Canada for Alzheimer's/dementia and include an article from the internet about it. I have traveled around the world and have found that the vast majority of doctors are very willing to write a prescription for a medicine that could help. American doctors in general are the most strict when it comes to writing prescriptions for off label use, and that is because of the American legal system, where doctors are often sued by their patients. Good luck to you and your father.


Michael King
Posted: Tuesday, April 9, 2019 11:33 AM
Joined: 4/9/2019
Posts: 3


xiaofeng,

Has your father been taking Montelukast? And if so can you share the results? Thanks!


sixcats
Posted: Thursday, December 26, 2019 12:02 AM
Joined: 8/25/2018
Posts: 19


Larrytherunner, I so need to connect with you regarding Singulair. How can I message you? Really could use your input and advice. Molokai 16
Lxy
Posted: Wednesday, January 1, 2020 10:16 PM
Joined: 1/20/2018
Posts: 20


I have a question about having someone in another country buy Montelukast and mail it to us here in the USA. 

Would there be a problem with US customs inspecting the package and then seizing it?


BadMoonRising
Posted: Wednesday, January 8, 2020 6:20 PM
Joined: 4/22/2017
Posts: 334


https://www.clinicaltrials.gov/ct2/show/NCT03991988

Recruiting for Montelukast study at Emory University.


Brezze23
Posted: Friday, January 10, 2020 1:20 AM
Joined: 9/7/2019
Posts: 39


3 years ago, the USA border honored prescriptions from other countries. I am not sure now . But one can find out. Some people have friends or relatives  who live in USA border towns who can mail them the medicines they need. Hope this help.
Brezze23
Posted: Friday, January 10, 2020 1:50 AM
Joined: 9/7/2019
Posts: 39


I do not know how to transfer a link. Apparently  medicines  can be brought from Mexico  as long as they are not FDA controlled  like opioids.  The cost of a box of 30 10mg box is 288 pesos about 15.50 dollars. H
Larrytherunner
Posted: Friday, January 10, 2020 11:28 AM
Joined: 2/26/2016
Posts: 243


Lxy, my earlier post was removed, so this is the short version. A person can send prescription drugs from a foreign country if you include a prescription from a doctor in that country. You are limited to a three month supply. Unfortunately a three month supply of montelukast for asthma is only three boxes (30 tabs of 10 mg per box). If you are taking montelukast twice a day for alzheimers, it will last only 45 days.

 

DHL does a great job getting through customs. I don't know if regular mail would make it through customs. FedEx does not allow prescription or non-prescription deliveries.

 

If someone is bringing it across the border, this person still needs a prescription, and the 3 month supply restriction still applies.

 

 

 


HowDoYouDeal
Posted: Thursday, January 16, 2020 11:54 AM
Joined: 2/17/2019
Posts: 380


Singulair is being reformulated to treat Neurodegenerative Disease

 

INTELGENX PROVIDES UPDATE ON PHASE 2A MONTELUKAST VERSAFILM™ CLINICAL TRIAL

January 23, 2019

Eight Alzheimer’s Disease Patients Randomized to Date with Two Additional Sites Expected

SAINT LAURENT, Quebec, Jan. 23, 2019 (GLOBE NEWSWIRE) -- IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT) (“IntelGenx”), a leading oral drug delivery company, today provided an update on its Phase 2a study of Montelukast VersaFilm™ in patients with mild to moderate Alzheimer’s Disease (AD).

To date, seven study sites across Canada have randomized eight subjects, many of which commenced dosing in late-2018. IntelGenx sponsored study sites are actively screening for new patients and IntelGenx expects enrollment to accelerate following the holiday season hiatus. In addition to opening its planned eighth trial site, IntelGenx is preparing to open an additional site in Montreal, bringing the total number of sites to nine.

“We are looking forward to commencing patient recruitment at our eighth site in the coming weeks, as well as opening an additional site in Montreal by the end of first quarter 2019,” said Dr. Horst G. Zerbe, President and CEO of IntelGenx. “Although in its early stages, this is an exciting trial for IntelGenx as we work with our study sites to achieve a shared goal of finding a treatment that benefits patients living with this most unfortunate and debilitating disease.”

“Unlike traditional dosage forms, our Montelukast VersaFilm™ is engineered to deliver Montelukast with an improved bioavailability, which may be more efficacious than known Montelukast dosage forms in crossing the blood-brain barrier,” contends Dr. Zerbe.  “As a result, our VersaFilm™ technology has the potential to be broadly applicable to a wide variety of other pharmaceutical treatment options.”

The randomized, double-blind, placebo-controlled Phase 2a “proof of concept” study will enroll approximately 70 subjects with mild to moderate AD. The study will evaluate the safety, feasibility, tolerability, and efficacy of Montelukast buccal film following daily dosing for 26 weeks.

About Montelukast VersaFilm™

Montelukast is a leukotriene receptor antagonist that was approved by the U.S. Food and Drug Administration in 1997 for the treatment of asthma and seasonal allergic rhinitis. IntelGenx is working to repurpose Montelukast as a therapeutic to treat neurodegenerative diseases by re-formulating the drug into an oral film-based product. IntelGenx's proprietary VersaFilm™ technology is especially suited for special needs patient populations, and the Montelukast VersaFilm™ product offers many distinct advantages over tablets for Alzheimer’s Disease patients, including the avoidance and minimization of first-pass-effects, ease of administration, improved API bioavailability, lower dosing and toxicity, better acceptability and improved compliance.

In a recent Phase 1 study, IntelGenx demonstrated that an oral film formulation of Montelukast is safe and tolerable in healthy subjects, reduces the first-pass-effect and has a 52% higher bioavailability compared to the regular Montelukast tablet, demonstrating a clear advantage of delivering Montelukast via film. IntelGenx's oral film also crossed the blood-brain barrier, an essential feature for treating degenerative brain diseases.

About IntelGenx

Established in 2003, IntelGenx is a leading oral drug delivery company primarily focused on the development and manufacturing of innovative pharmaceutical oral films based on its proprietary VersaFilm™ technology platform.

IntelGenx's highly skilled team provides comprehensive pharmaceuticals services to pharmaceutical partners, including R&D, analytical method development, clinical monitoring, IP and regulatory services. IntelGenx's state-of-the-art manufacturing facility, which was established for the VersaFilm™ technology platform, offers by supporting lab-scale to pilot- and commercial-scale production. More information about the company can be found at www.intelgenx.com.

Forward Looking Statements

This document may contain forward-looking information about IntelGenx's operating results and business prospects that involve substantial risks and uncertainties. Statements that are not purely historical are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. These statements include, but are not limited to, statements about IntelGenx's plans, objectives, expectations, strategies, intentions or other characterizations of future events or circumstances and are generally identified by the words "may," "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," "could," "would," and similar expressions. All forward looking statements are expressly qualified in their entirety by this cautionary statement. Because these forward-looking statements are subject to a number of risks and uncertainties, IntelGenx's actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed under the heading "Risk Factors" in IntelGenx's annual report on Form 10-K, filed with the United States Securities and Exchange Commission and available at www.sec.gov, and also filed with Canadian securities regulatory authorities at www.sedar.com. IntelGenx assumes no obligation to update any such forward-looking statements.

Each of the TSX Venture Exchange and OTCQX has neither approved nor disapproved the contents of this press release.  Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Source:  IntelGenx Technologies Corp.

For more information please contact:

Stephen Kilmer
Investor Relations
(514) 331-7440 ext 232
stephen@intelgenx.com

Or

Andre Godin, CPA, CA
Executive Vice-President and CFO
IntelGenx Corp.
(514) 331-7440 ext 203
andre@intelgenx.com

IGX Logo Medium Size.jpg

Source: IntelGenx Technologies Corp.

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BadMoonRising
Posted: Thursday, January 16, 2020 7:59 PM
Joined: 4/22/2017
Posts: 334


Update: Jan 15, 2020

http://www.intelgenx.com/investors/press-releases/press-release-details/2020/IntelGenx-Receives-Health-Canada-Authorization-to-Proceed-with-New-Amendment-for-Montelukast-VersaFilm-Phase-2a-Trial/default.aspx

“We are delighted with Health Canada providing the authorization for IntelGenx to proceed with our amended protocol, which enables us to continue the BUENA trial at an increased daily dose...”    "In addition, we continue to evaluate the trial’s expansion to the United States via a potential Investigational New Drug Application filing with the U.S. Food and Drug Administration.”



Larrytherunner
Posted: Friday, January 17, 2020 10:08 PM
Joined: 2/26/2016
Posts: 243


I am certainly glad that Intelgenx has gotten approval for higher dosages. My experience is that one 10 mg tablet per day is not enough to get the full benefit.

Emory University has already gotten FDA approval for up to 40 mg per day. Hopefully by the end of the year, we will get some positive results from both trials.