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Nuedexta Clinical Trials

The Clinical Trails of Nuedexta Medication

Handsome young doctor holding clipboard and analyzing the results of clinical trials with elderly patient. Isolated on white background.

Nuedexta is a drug which is being used to treat people who are suffering from a condition known as Pseudobulbar affect. Nuedexta is still quite a young, and untested drug, and there are a series of clinical trials being performed at the moment to determine the effectiveness and safety of the drug.

The Nuedexta clinical trials have, so far, been quite positive and promising. It should not be long before the drug is prescribed commonly to treat people with PBA. There are always safety concerns with new medications, and the outcomes of the clinical trials so far are being watched quite closely.

Nuedexta Has Been Licensed for Marketing in Some Parts of the World

Neudexta was given a marketing license in 2013 by the EMA. The license was withdrawn for EU marketing in 2016 and did not get licensed at all for marketing in the UK. For it to be licensed, it will need far more testing than it has had so far. The drug is still available in the USA.

Effects of Nuedexta Studied in Clinical Trials

One of the most recent Nuedexta clinical trials focused on the effects of the drug on nursing home patients who suffered from PBA. The experiment spanned six months and looked at a total of 125 patients across several states. Unfortunately, evidence from this study was inconclusive because there was difficulty recruiting patients, so the study was terminated before the six month period was up.

Another study looked at the safety and tolerability of Nuedexta for managing PBR in people who had suffered from a range of conditions, including traumatic brain injury and dementia, as well as strokes. This study spanned 12 weeks and used a 20mg dose of Nuedexta. The study engaged 367 participants and showed promising results across several outcome measures relating to emotional episodes and other difficulties.

Nuedexta is Often Mis-Prescribed

red pills or capsules in blue background

Clinical trials have been promising when Nuedexta has been tested for PBA alone. However, there are some concerns about the safety of the drug and the way that it is prescribed. Recent research and studies into the prescription of the medication indicate that doctors often prescribe it to people who have dementia, Parkinson’s, or another underlying condition. This is concerning because the drug has not been tested for use in this way. It is uncertain whether there may be interactions between Nuedexta and other drugs, or whether it may have unexpected impacts on people who are suffering from other conditions. This is something that the medical community is calling for further research.

Technically, prescribing Neudexta for PBA that is associated with other underlying conditions is off-label. This is something that a lot of doctors and consultants overlook, but it should be a matter of significant concern given the potential for the drug to have unwanted side-effects.

Indeed, Medicare has asked that insurance companies monitor the prescription of Nuedexta. That’s because it is being marketed aggressively for dementia patients. Though, it has not been properly tested and trialed for that kind of use. It is also being marketed for Alzheimer’s. Other drugs are likely to be far better suited for managing the symptoms that people living with Alzheimer’s are experiencing. People who use Nuedexta for Alzheimer’s are more likely to experience falls, and other secondary issues, including UTIs, than those who are given more appropriate drugs.

One challenge that doctors face is that there are not many options for managing the behavioral issues associated with Alzheimer’s and dementia. It can be tempting to use something like Nuedexta, which may help with those issues in the short term. Unfortunately, Nuedexta is just a band-aid for such problems, and it is not going to manage the condition itself. In the vast majority of cases, it would be better for doctors to find ways to proactively slow the progress of Alzheimer’s or to find ways for the patient to cope with dementia without using an off-label drug that has not been tested for that kind of application. Doctors and nursing home workers are encouraged to avoid this kind of excessive over-prescription until more data is clarifying the safety of the drug.

Nuedexta Reviews and Testimonials

What Users of Nuedexta Have to Say

Nuedexta is what many might refer to as the drug of choice for treating Pseudobulbar Affect, also known as PBA.  That reference is typically given by the medical community.  The real question is, “what are users saying about the medication?”  What kinds of reviews and testimonials are available regarding the use of Nuedexta.  Let’s provide some of what the Nuedexta subscribers are saying here.

Before getting into the comments of these patients let briefly discuss some of the background and uses of the medication as well to put the testimonials in context.  This will also help provide a little more reference for the statements these users have made.

We are going to make the assumption that there is already an understanding of what some of the side effects, uses of the medication, cost and other items are related to the medicine to avoid unnecessary dialog.  However, if you’ve reached this article without knowledge of that detail, you can read more about those things here.

Now for the Nuedexta reviews

In looking at various locations and the testimonies provides, the following is what patients taking the medication have to say:

For Pseudobulbar Affect “I started nuedexta almost two months ago due to severe mood swings, angry outbursts and frequent crying episodes. Thanks to this medicine, these behaviors have pretty much stopped. I do think for two generic drugs, that the price should be lower.”

This review was offered by a commenter going by the name of riverrat on April 18th of 2016. Ten out of a possible ten was given by this reviewer, and the comment was found on the website.  Here is another from that site.

For Pseudobulbar Affect “I have MS and my mood swings were unbearable. I feel like this drug has balanced out my brain. Not only am I no longer sad and suffering, I think more rationally. I am going through a very stressful time in my life. Normally I should just want to lay in bed and cry. This drug has put ME in control of my emotions! I have tried a variety of anti depressants.. They made me feel numb . I hated them. This drug is different!!! I also have a history of self medicating with alcohol to cope with my anxiety when a very stressful situation occurs. Since I have started this med, I have no desire or urge. I’m not one to get online and write a review.. But I feel like this is helping me live again.. And I want to share the word!!”

This reviewer gave an 8 out of a possible 10 rating.  The reviewer was belladonna4880, and the review was provided on August 29th, 2015. also offered some oral reviews on their website.  In these reviews, the age and gender of the patient are provided.  Here are a couple of the most recent ones.

“I have Multiple Sclerosis. I started taken this Medication, due to uncontrollable crying. After 2 months, taking Nuedexta ONCE a day, I started to have INCREASED SPASTICITY in my hands & right calf & foot. My psychiatrist, NEVER informed me about this side effect. Just make sure, you speak with a PHARMACIST, BECAUSE most doctors don’t know anything about the medications they prescribe!! TRUST ME on that, I’m a RN.”

The ease of use rating given by this review was a four out of possible five stars.  However, the other ratings were not as positive.  For effectiveness and satisfaction, this rater gave both a 1 out of 5 stars.  No names were attached to this review.  The rater was a female between 45 and 54 years of age.

“I was on Neudexta for about a year and was in control and felt like I could do anything without fear of crying. But then I started to itch all over my body. After about a week, an itchy rash appeared. After an appointment with my neurologist he advised me to discontinue the drug. The itching and rash disappeared and the crying came back. I have other allergies that cause anaphylaxis so I stopped taking Neudexta.”

This reviewer gave 5 out of 5 stars for effectiveness, ease of use, and satisfaction.  Again, there are no names offered with the review and it was provided by a female between 65 and 74 years of age.

More Nuedexta Testimonials reports these evaluations from Nuedexta patients.

newton 1971 says: “This has been a miracle drug for myself as I no longer have the outburst of unexpected crying and or laughter.”

His rating for effectiveness is 4 out of 4.  He also gives 1 out of 4 for side effects which indicate none. His evaluation was presented May 14th, 2017.
cruiser reported, “When I first took it it was great. Now some of the crying is coming back. I wish I could find something else.”

For effectiveness, he gave 2 out of 4 possible and as far as side effects he gave a rating of 1 out of 4 indicating no side effects.  He review was written October 10th, 2008.

There are other reviews of this medication available by those who have researched the subject.  However, these reviewers don’t necessarily have personal experience in using the drug.  An example of this review can be found at

Have you taken this medication?  This community would appreciate reading your Nuedexta review.  Comment below with your review of Nuedexta to help our readers.

Is Nuedexta A Psychotropic Drug?

Nuedexta as a Psychotropic

Can Nuedexta be classified as a psychotropic drugA psychotropic drug is a type of drug that is used to treat psychiatric conditions. Doctors prescribe some psychotropics fairly commonly. Ambien is a popular sleep aid; Prozac is a popular anti-depressant. It’s not unusual to see people taking psychotropic drugs on a regular basis.
Some people have wondered whether Nuedexta, a drug that is used to treat neurological conditions, qualifies as a psychotropic. It’s true that this medication commonly addresses issues with the brain. However, most people do not consider it to be mind-altering.
What Is Nuedexta?
If Nuedexta isn’t a psychotropic, then what is it? It’s classified as a central nervous system or CNS agent. It can affect the brain because it impacts the nervous system.
Why Isn’t Nuedexta A Psychotropic?
Generally speaking, Nuedexta isn’t used to treat any psychiatric conditions. More often than not, it treats medical problems. A prescription of Nuedexta is for people that experience uncontrollable crying or laughing because of a neurological disorder. It’s easy to mistake those kinds of symptoms for psychiatric problems, but they certainly aren’t the same thing.

Who Is Being Prescribed Nuedexta?
Nuedexta is commonly used to treat people with ALS, or Lou Gehring’s Disease. This drug has helped a lot of individuals to reduce the severity of their symptoms. This medication is also being prescribed to Alzheimer’s patients. Drugs like Nuedexta can treat some common neurological symptoms.
More recently, people have been using Neudexta to help adults with autism. Because autism is a neurological disorder, it has been quite useful. It has even been prescribed to people with brain injuries. If someone experiences the PseudoBulbar Affect, a neurological condition that causes people to experience involuntary episodes of laughing or crying, it is likely that they will be given this drug.

It is unlikely that the classification of this medication will be fall under a psychotropic listing at any point in the future. Even if it is used to treat psychiatric conditions at some point, the drug will remain a CNS agent. There is no reason for experts to change its classification.
If you believe that you would benefit from taking Nuedexta, you should talk to your doctor about it. Tell them that you have heard Nuedexta has a positive effect on people that experience the PseudoBulbar Affect. See if your doctor thinks this drug would help you.
Like any other drug, Nuedexta does have said effects. With that said, early testing surrounding this drug has been extremely positive. If you are a patient that would benefit from Nuedexta, it is likely that your doctor will be willing to prescribe it to you.
Now that you know a little bit more about psychotropics and Nuedexta, you are ready to have a conversation with your doctor. Don’t be afraid to talk to your doctor about medications that might help you. After all, managing your health is part of your doctor’s job.

Can Nuedexta Cause Headaches?

It is estimated that approximately 2 million people in the United States are affected by a condition, known as the Pseudo-Bulbar effect. It results in bouts of inappropriate and uncontrollable crying or laughing. Typically, it is associated with a brain injury or other conditions, such as Parkinson’s disease, Alzheimer’s, Lou Gehrig’s disease, stroke and multiple sclerosis. Your doctor may prescribe Nuedexta to treat the symptoms of this condition.

Many people who have been prescribed Nuedexta are wondering if headaches are a side effect of the medication. Other individuals who may already be taking the drug and have a headache wonder if it is associated with the medication or if it is just a random event. Taking a closer look at the side effects can help answer that question and see if it is something that should be discussed with your physician.

There are some side effects that may be associated with using Nuedexta, including dizziness, diarrhea, vomiting, coughing, weakness, and drowsiness. Although headaches are not typically listed as one of the primary potential side effects of this drug, it has been reported by some individuals. According to at least one study, approximately 13% of those who use Nuedexta report a headache as a side effect. Does that mean that it is likely that you are going to have this problem as well?

Before the time that your physician prescribes Nuedexta, he will discuss your current medical condition and any other medications that you are using. Knowing this information can help to reduce the possibility of side effects, including a headache. At times, drug interactions can lead to unexpected side effects, which is something that the doctor is trying to avoid by having a list of medications that you are taking. The same can also be true for your current medical condition, as there may be certain factors that could increase your possibility for headaches.

Another issue that may be associated with using Nuedexta are some severe drug interactions. These are also things that need to be checked on prior to the time that you are provided with a prescription. For example, Nuedexta may not work well with certain tricyclic antidepressants, digoxin or aliskiren. There may also be other medications that affect how quinidine, one of the medications in Nuedexta, is removed from the body. Using this drug along with a MAO inhibitor could cause potentially fatal drug interactions.

One of the most important things to keep in mind is that all side effects should be discussed with your physician if they become a problem. Regardless of whether it is a headache, nausea or any other problem you are experiencing, your doctor may be able to come up with a solution to reduce the issue or to remove it altogether. Headaches are not typically a severe side effect, but if they should happen become serious, you should seek medical attention without delay. More than likely, you will be able to use Nuedexta without headaches, but you should always watch for the potential problem.

What is Nuedexta and Is It Available in the UK?

Nuedexta is a drug that is used to help people to manage emotional outbursts. It is often used to manage uncontrollable crying. Some individuals who suffer from MS benefit from taking Nuedexta, and the drug has been approved for use in the United States since 2010 but has taken longer to be approved in other parts of the world.

In the United Kingdom, Nuedexta was approved for use to treat certain MS symptoms in 2013, but it is a prescription only drug, and its use is limited to the treating of things like uncontrollable emotional outbursts in MS sufferers. Around ten percent of people who live with MS suffer from uncontrollable bouts of tears or laughter, which are disproportionate to the person’s real emotional state. The condition can be embarrassing, confusing and even distressing for both the sufferer and for the people who care for them or work with them.

The condition is known as Affective Release, and it is thought to be caused by the MS-related nerve damage that builds up over time. MS can damage the nerves in the brain that control both the way emotions form and the way they are regulated, which is what causes the disproportionate expression of emotion.

One difficulty surrounding Affective Release is that it makes it hard to tell when someone with MS is feeling troubled, and this means that real issues are not taken as seriously as they might be. Nuedexta helps to regulate the mood and the expression of emotion in people with MS, and this means that it is easier for those people to express difficulties and to get help when they need it.

Nuedexta can help individuals who have Affective Release, and the PseudoBulbar Affect because of other medical issues as well, but this is something where exploration is still occurring in the UK. In the United States, Nuedexta has been tested extensively, and it has been found that within one week of taking it, sufferers experience 44 percent fewer episodes of uncontrolled laughing or crying, and within 12 weeks, they experience 82 percent fewer episodes. Almost one-third of people who take the drug find that they completely stop experiencing events within the first two weeks of taking the drug.

Nuedexta is just one example of a new, life-changing drug that has come on the market in the last few years. Drugs like this need to be monitored carefully and extensively tested before they are released onto the market because there are so many risks associated with them. While Nuedexta is generally considered to be safe, the FDA and similar organisations in the UK, India, and Europe are concerned about making sure that drugs are as safe as possible. This safety measure means ensuring that they are not addictive and that they are not going to cause any lasting harm or interact with other medications. It takes many years to put a drug through that approval process.