Intuniv: One Step Closer To FDA Approval for ADHD
ByThirty percent of children with AD/ADHD cannot tolerate taking stimulant medications.
For these individuals, the recent news that Shire is one step closer to gaining FDA approval for its time-released non-stimulant INTUNIV is welcome news.
Intuniv provides a 24-hour evenly released dose of the medication guanfacine. Specifically, guanfacine improves the symptom of the inability to concentrate in children with ADD/ADHD.
When given in conjunction with stimulants, it may also help reduce the aggression and the insomnia normally associated with the use of these drugs.
In fact, some physicians already prescribe it – in an immediate release version and under various brands – to their patients with ADD/ADHD along with other medications. The most common brand used is Tenex. This medication, however, appears not to be very effective at alleviating either the attention deficit or the distractibility seen in children with ADD/ADHD.
Two advantages of INTUNIV
Manufactured and marketed as INTUNIV, though, this form of the medication would hold two distinct advantages over what is currently being used. First, it would be approved specifically for the treatment of ADD/ADHD. And secondly – and most importantly to those whose concentration is low – it would relieve the unevenness produced by the immediate-release version of guanfacine.
Guanfacine works well in improving concentration, but it only lasts several hours, and once the medication wears off attentiveness wanes again.
Recent clinical trials conducted as part of the FDA approval process show that INTUNIV is extremely effective at boosting concentration levels consistently for a 24-hour period
The data the FDA scrutinized included the pooled analysis of results from two double-blind trials. Both of these studies used the teacher based ADHD Rating scale as the criteria for improvement.
One group of children received INTUNIV for the other group received a placebo which contained no medication.
All groups which received the medication scored significantly better in the rating scale than those who received the placebo.
The studies also examined the length of time the medication was effective for these children. Assessments were made at 12, 14 and 24 hour periods following the administration of this drug. Again the data showed significant improvement in the concentration of the children at each of these points in time.
Mild and moderate side effects of INTUNIV
Between 75 and 80 percent of the children, did display mild adverse side effects while taking INTUNIV, most of which appeared within the first two weeks and eventually tapered off. These seemed to be dose-related and included: upper abdominal pain, constipation, dizziness, hypotension, sedation, dry mouth, and drowsiness.
The most common of these side effects were related to sedation.
The medical community has been examining guanfacine for its effectiveness since 2001. That year a study appeared in the American Journal of Psychiatry showing that guanfacine to be a safe and effective treatment for children with ADHD and those who suffer with tic disorders.
The medication, according to the journal article, produced a mean improvement of 37 percent in the total score on teacher-rated ADHD Rating Scale following eight weeks of treatment. This was compared to the eight percent improved for those who received the placebo.
INTUNIV is not a controlled substance — as stimulants are — and does not appear at this time to carry any risk for either potential for abuse or dependence.
The FDA has issued an “approval letter†for INTUNIV, which means that it is prepared to approve the new drug application as soon as certain conditions are met, such as any requests for additional information.
How guanfacine works
Guanfacine works, according to Shire, by acting indirectly on the prefrontal cortex of the brain. Located directly at the very front of the brain and directly below the forehead, the prefrontal cortex controls what are known as the executive functions. This includes the resolution of conflicting thoughts, the choices involved in “right or wrong†and “good and bad†decisions, as well as the prediction of future events.
This section of the brain also governs social control that is it is the area used when we suppress or emotional urges.
Guanfacine is a selective alpha-2A-agonist medication.
Admittedly, the treatment of ADD/ADHD is a highly individualized challenge. Discovering the most effective combination the proper medications and other forms of therapy may mean attempting to use several medications in various combinations as well as varying doses. What is appropriate for one child or adult, may not be either appropriate or effective for another.
Nearly 8 percent of all school-aged children have been diagnosed with ADD/ADHD, according to the U.S. Centers for Disease Control and Prevention. While not normally thought of as a disorder affecting adults, some 4.4 percent of all adults, ages 18 to 44 are affected.
The major characteristic of ADD/ADHD is an inattention or hyperactivity-impulsivity that exceeds those normally observed in most individuals. Official diagnosis of this disorder can not be made until the symptoms have been observed for at least six months.
References:
Pro-drug gets attention,
http://www.sciam.com/article.cfm?id=pro-drug-gets-attention, accessed 11 Jun08
Guanfacine, http://www.depression-guide.com/guanfacine.htm, accessed, 7 Jun 08
Intuniv reduces ADHD symptoms, http://www.realmentalhealth.com/adhd/adhd_toc.asp, accessed 6 Jun 08
Shire Investigational Nonstimulant INTUNIV Showed Significant Efficacy In Reducing ADHD Symptoms, http://www.medicalnewstoday.com/articles/106801.php, accessed 10 Jun 08.
What is prefrontal cortex?, http://www.wisegeek.com/what-is-the-prefrontal-cortex.htm, accessed, 11 June 08
Larry Scahill, M.S.N., Ph.D., Phillip B. Chappell, M.D., Young S. Kim, M.D., Robert T. Schultz, Ph.D., Lily Katsovich, M.S., Elizabeth Shepherd, M.A., Amy F.T. Arnsten, Ph.D., Donald J. Cohen, M.D., and James F. Leckman, M.D. A Placebo-Controlled Study of Guanfacine in the Treatment of Children With Tic Disorders and Attention Deficit Hyperactivity Disorder, http://ajp.psychiatryonline.org/cgi/content/abstract/158/7/1067, accessed 11Jun08
Technorati Tags: Intuniv, Shire, ADHD, ADD, ADHD Medication, ADD Medication
28 Comments
June 19th, 2008 at 12:09 pm
Re.. Natural vitamin supplements…
Dear Dr. Kenny Handelman,
Do you have any information &/or suggestions re.. Phosphatidylserine for ADD/ADHD patients (children & adults)?
Thanks.
June 19th, 2008 at 5:24 pm
Thank you for the information on INTUNIV. I had not heard of it before.
June 23rd, 2008 at 11:06 am
Thank you for the information on Intuni and guanfacine. I’ve never heard of these drugs either. I currently take Vyvanse with much success, but have some small issues when the medicine seems to be leaving my system. Maybe Intuniv would help with those issues. I’m excited about this possibility and will be watching when Intuniv is available to the public.
Thank you!
June 23rd, 2008 at 3:58 pm
Hi,
I’ve heard about this in the States but was not aware it was available in Canada. If it is I’m quite interested insofar as I have borderline high blood pressure and if I remember quickly this medication actually lowers blood pressure (as opposed to most stimulants).
So I guess my question, is it available here in any form.
Mike Craig
June 24th, 2008 at 8:37 am
Hi Mike,
No, we don’t have Tenex or Intuniv in Canada. The closest one is Clonidine. This is in the same family. It does lower the blood pressure, and it helps with sleep and helps to settle hyperactivity. It doesn’t seem to do well for the inattention.
Intuniv may come to Canada – but it likely won’t be for a few years.
All the best,
Dr. Kenny
June 24th, 2008 at 1:40 pm
My daughter has ADHD and we’ve tried stimulant medications, which are terrible for her. We have tried Vyvanse with great hope but that to made her hyper (talk, talk, talk without stopping) I hope this Intuniv is our answer. In what form is this medication going to be available? That’s our other problem, she does not take capsules or pills. Looking forward to the release of this new drug. Debbie
June 30th, 2008 at 1:58 pm
Any idea about INTUIV’s release date in the U.S.?
I have tried just about everything else— stimulants (including Vyvanse), Stattera, Wellbutrin, and now Modofanil, and so far nothing works…
Thanks,
Leslie
July 22nd, 2008 at 12:18 am
Doctor I got a quick question for you. I am on Disability here in Vancouver I was wondering do you know if there are any non-stimulant drugs for Adult ADHD that would be covered (affordable)by the B.C government and are avaliable in Canada? And what would be the most effective for Adult ADHD in your experience.I truly love your Blog and in my opinion and I am sure many others this is by Far the best ADHD blog on the web.
July 23rd, 2008 at 9:49 am
Hi Chase,
Regarding a non-stimulant in BC – there is Strattera. However, I believe that the BC government doesn’t provide coverage for it. You’ll need to check with your doctor. In Ontario, it is available with a special application.
Best,
Dr. Kenny
July 30th, 2008 at 1:07 am
I love your blog Dr. Handleman! I learn so much! Our 9 year old has been diagnosed ADHD and currently we have him on Biphentin in the morning, followed by Ritalin at noon to make it thorough the school day. He is unable to swallow pills so we open the Biphentin capsule and he takes the granules and he chews the Ritalin tablet. When the medication wears off, it hits him quite hard and he talks non-stop. Is there any other medication you can recommend? Is there any hope of Canadian approval for the Daytrana patch they have in the US?
Thanks & best regards,
Brenda
August 25th, 2008 at 3:53 pm
Intuniv: One Step Closer To FDA Approval for ADHD…
Intuniv provides a 24-hour evenly released dose of the medication guanfacine. Specifically, guanfacine improves the symptom of the inability to concentrate in children with ADD/ADHD….
July 9th, 2009 at 4:15 am
Hi,
A few questions:
It appears Intuniv has the same mechanism of action as Clonadine, if so how revlutionary is this drug? I know they spent the money to pursue the indication, but if it is the same I guarantee that when my doctor gives me Intuniv, I will end up getting Clonadine bc of insurance (blue shield). I take Focalin XR now, but am concernaed about bpllod pressure, should I ask my MD about CLonadine. wellbtrin and strattera did not work for me.
Best Regards
July 13th, 2009 at 1:59 pm
Hi,
Intuniv is close to Clonidine – but it is actually the same as Tenex (which is in the US). It is just the long acting form of the medicine.
Best,
Dr. Kenny
November 16th, 2009 at 4:44 pm
My son has been taking Intuniv for about 5 days. He is taking 1MG. He has good and bad days. I think we will have to move him to the 2MG dose. The side effects of the stimulants were not good for him. I am praying this medication works.
November 24th, 2009 at 9:40 pm
My son is currently taking 70mg of Vyvanse. His dr gave us Intuniv today to try for a month. He said it was fine to keep him on the same dose of Vyvanse, while taking the Intuniv. Is this really safe? Im concerned he will be over-medicated. I think over the holiday this will work out fine since he is not in school, and I can monitor his effects, im justg concerned about giving him both at once. What is your opinion?
November 27th, 2009 at 7:20 pm
My 9 yo grandson is 4 foot tall and weighs 45 pounds — he’s currently on Concerta. Not only is he skin and bones but he’s having weird side effects: constantly “sniffing”, talking non stop and after the medicine was upped to 54 mg. he started repeating himself either the first part of what he wanted to say 5 or 6 times (well, Grammie – well, grammie – well, grammie etc.) or repeating the whole thought 5 or more times like he couldn’t stop himself. He’s taken Foculin, Adderall, Vyvance and Daytrana patch prior to the Concerta all with alarming side effects from talking nonstop for 3 hours to extreme fear that a boy he knew was going to set his house on fire and kill his family to joint pain so extreme he cried and said the affected joint was broken. At this point I just think he should be off the meds but he can’t focus enough to learn at school! I guess my question is are there any natural remedies that really work — I too have heard that 300mg daily of Phosphatidylserine will control the ADHD symptoms but I seem to remember reading that it can be an appetite depressant. What to do? Help!
November 29th, 2009 at 11:06 pm
Jacque –
With these types of side effects – I suggest you ask your doctor about induction of psychosis, agitation, obsessiveness, or even mania.
I really don’t know enough to make specific comments – but I suggest you ask your doctor. It’s possible that there is more going on here than just ADHD, and talking to your doctor may help.
Best,
Dr. Kenny
http://www.SafeADHDMedication.com
November 29th, 2009 at 11:10 pm
BransMom,
A new study came out showing that it’s fine to take Intuniv with the stimulant medicines as well:
http://www.prnewswire.com/news-releases/shire-announces-publication-of-open-label-study-on-coadministration-of-intunivtm-guanfacine-extended-release-tablets-with-stimulants-70182537.html
Best,
Dr. Kenny
http://www.SafeADHDMedication.com
December 2nd, 2009 at 1:57 pm
My son started Intuniv in early November. He was previously on Clonidine for ADHD (he also has Tourette’s). We love this drug. He is focusing in school again, not crying as often. The tics remain, but who cares, as long as he can focus, enjoy life and keep himself out of trouble as a result of implsive behavior. My son is 10 and takes 4mg. If your child cannot take stimulants, talk to your doctor about this medication. It has worked wonders for my son. We have been through many drugs for ADHD and trying to find the right combination after the Tourette’s started. Clonidine is OK, but not as good as Intuniv.
Tausha
December 8th, 2009 at 12:45 am
My son started Intuniv just a few days ago. He started with the 1mg and will work up. He asked if this was what it felt like to be normal on the first day! We are very hopeful that the stimulants can go away. They cause tics and some aggression with him and does not help with anxiety, just makes it worse. It will be considered miraculous if we really find something that can work 24 hours or maybe even 16 without any bad side effects. We will wait and see.
December 15th, 2009 at 12:57 pm
We just started my son on Intuniv. We have been struggling for as long as he is old, 9 y/o. I have 3 boys, he is the only one that won’t or cannot fall asleep in the car. WE drove 17 hours straight a few years ago and he only slept a total of 45 minutes. He has issues with aggression and uncontrollable tantrums. He has severe learning disabilities which took over a year to finally get the results and testing completed. So, after many years of battling his behavior and my insistence that this can’t continue we finally received this medication to try. I am hopeful that we will see the benefits as others have I am afraid to see how the insurance company will treat this prescription. It is unfair that they can dictate what they will and will not cover. When every child is an individual and when new and improved medications become available that may treat a condition more appropriately it seems unethical that they can choose not to cover a medication. How can we, as parents, fight the battle of this injustice? After all we go through with raising these children with attention and learning disabilities it is a slap in the face to think that insurance can not cover the one thing that may actiually help.
December 15th, 2009 at 7:33 pm
My son also has ADD and Tourette’s diagnoses and is thirteen. He has been on Clonidine since he was 6 after taking strattera….Tourettes specialist in st louis told us children who will get tourettes will often be prescribed stimulant drugs for add and get the symptoms of tourettes earlier than expected if they had’nt. That is what happpened with my son Ryan. We are getting ready to talk to his Dr. about Intuniv. The clonidine has such drastic side affects of lethargy and sleepy behavior! I hope this will be a better answer. Would’nt mind having the email of Tausha Hathaway. Another Mom with the same situation. My email is ryanos93 @yahoo.com if interested.
January 6th, 2010 at 8:29 pm
MY SON IS 11YRS HE IS TAKING VYVANCE 50MG HE IS DOING GOOD BUT WITH SOME AGRESSIVE BEHAVIOR, I WILL LIKE TO KNOW IF ITS SAFE FOR HIM TO TAKE BOTH MEDICATIONS VYVANCE AND INTUNIV. THANK YOU
January 8th, 2010 at 8:09 pm
My son Cole is 10yrs old and has been on medication for severe ADHD since he was 4. His current medications are Concerta and Clonidine, which have worked well for him, until the last few months. His behavior has gotten so bad at home and school. He is very impulsive, calling people names, throwing food in the cafeteria, writing on school property, etc. Things are very stressful. His doctor did not want to change his medication, until I called in tears, and he prescribed Intuniv which we will start tomorrow, but he did not say anything about stopping Clonidine. Is it safe to give together?
January 21st, 2010 at 6:21 pm
My son is 6 yrs old and has been taking adderal 20 mg for over six month, this week it has been from hell he has gone back to being aggressive and he’s behavior is out of control. The doctor has asked to stop using adderal for one week and we may start this new medicine.Hoping this one works.
January 28th, 2010 at 11:48 am
My son is 8 and has been taking intuniv for the past month. From the very first week I have seen a drastic change in his behavior at home and at school. He was on ritalin (10mg) and is still taking the ritalin. I have one concern doctor… please help me. My child has never had a problem with sleeping. Now that he is on the Intuniv and Ritalin he wakes up EVERY night around 1:00 or 1:30 am. and can not seem to go back to sleep. He tries but only manage to sleep for another hour but it is never a sound sleep… (I can call his name out and he immediately answers me, wherein in the past I would have to actaully go in his room and wake him up.) He saids that it feel like his stomach is growling, which causes him to wake up, but he can not get back to sleep. I am really concern that he is not getting the proper sleep seeing that he is in bed at 8:30 p.m, yet does not actually fall asleep until 9:30 p.m and is up again at 1:00 a.m. and still does not fall back to sleep easily. He is now on 3mg of the Intuniv and one side effect is that he complains of stomach ache. I am hopeing that this goes away, because this med has been a life changing experience. He no longer struggles in school and homework is never a fight anymore. Could you please tell me if the sleep and stomach issue should go away with time.
February 3rd, 2010 at 8:23 pm
Janice Webster …. my son is the EXACT same!! … i am so far pleased w/ the results of the Intuniv .. however, the doctors office told me today that they can’t give me any more samples (as they were giving me samples for the past 2 months) and now w/ the insurance the copay is quite high (as it is not a preferred method) but i would rather pay the higher co pay than the whole amount altogether … just w/ not working right now …
but if it helps my son .. it will be worth it
February 5th, 2010 at 1:46 am
I have a 15 year old son who has ADHD. He has been taking Abilify at night and Vvyanse during the day. I think the Vvyanse is making it worse on him. We go to the Dr. tomorrow and I am hoping to get some Intuniv to help with his moods and irritabilty it has been awful for a while now. My friends daughter is on the Intuniv and says it is so much better then all the stimulants. I am hoping it will work….somedays are extremly difficult. Here is hoping for some peace. :O)