What is Intuniv?
Intuniv is the latest ADHD drug from Shire PLC, the makers of Adderall XR, for tackling ADHD and it marks a big change in potential treatment options. It is not a stimulant like Ritalin or Adderall but instead its a selective alpha-2A receptor agonist. More simply, the active part of the drug helps specific parts of the brain to function more effectively. The key to making it an effective ADD medication is that it targets the area of the brain relating to the central nervous system. This, in theory has a calming effect, suppresses the fight / flight response and allows the normal functioning of the brain.
Intuniv is based on the drug Guanfacine (also known as Tenex) that is used for treating hypertension and blood pressure. In 2006 the makers applied to FDA to allow its approval as a treatment for ADHD and this was granted in June 2007. However Guanfacine is only effective for a few hours before the patient has to take more pills. In the ADHD market, parents want to be able to give their child a tablet in the morning before school and have it working all day. This makes life easier for the school who no longer have to give out medicines at lunch time.
Adderall XR has been very successful for Shire PLC because it proved to be an effective, time release version of the standard stimulant used in Ritalin. Intuniv is very much in the same mold. Taking the existing drug Guanfacine and repackaging it in a time delayed formula. It is not clear exactly how it works but most likely it will use the same system as Adderall XR. The pill effectively consists of two tablets, one of which dissolves quickly in the stomach providing an immediate dose, and the second tablet, protected by a special coating, dissolves a lot slower, delivering its medicine some hours later and at a slower rate. The effect is that the patient receives a continuous level of medication through-out the day.
Intuniv Trial Success
Intuniv has not yet been given full approval by the FDA. In a recent press release, Shire stated that a 25% reduction in ADHD symptoms were seen in children compared with a placebo. This sounds good but remember this against children receiving no treatment. How effective it is versus Adderall XR or non-medical interventions has not been measured. It is also worth remembering that Shire PLC are selling Intuniv and will therefore be putting the best possible spin on their results. Independent researchers often find that real-world results do not match up to the drug company’s trial results.
Side Effects and Other Health Worries
Unlike most other ADHD medications, Intuniv is not stimulant based and is not a controlled substance. This means it has no potential for abuse in the way that Ritalin etc have. This should mean the drug is safer to take for long-periods of time but there has been no research in this area.
Unfortunately the story with side effects is not so good. Over 80% of children using it ireported adverse events (medical problems) during the 20 day trial. Most are unconnected to the drug and represent the normal childhood health problems but only 71% of users on the placebo had adverse effects. This is a significant difference and clearly shows that Intuniv has health risks. Adverse events reported include somnolence (32 percent), headache (26 percent), fatigue (18 percent), upper abdominal pain (14 percent) and sedation (13 percent) plus constipation, dizziness, dry mouth, hypertension and sedation. Shire PLC describe these as non-serious problems and highlight that fractionally less children on the drug developed serious problems compared to the placebo.