ADD / ADHD, ADD / ADHD Medication, ADD / ADHD Treatment, Medication

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.

Secret Ingredient

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.

ADD / ADHD, ADD / ADHD Medication, ADD / ADHD Treatment, Medication

Vyvanse is the new ADHD medication from Shire PLC, the makers of Adderall XR. It marks a significant change in the range of medication available as it uses a different type of stimulant than other medications, it a has long duration and it is especially formulated to prevent substance abuse.

How Vyvanse Works

The active substance in Vyvanse is lisdexamfetamine and is chemically very close to Dexedrine Spansules, a stimulant occasionally prescribed for ADHD. The advantage of lisdexamfetamine over methylphenidate (used in Ritalin and Concerta) is that it has a long lasting effect. Taken in the in the morning, the peak effectiveness last one to four hours but had a notable effect on symptoms for 12 hours.

Traditional ADHD medications have been easy to abuse and this has led to dependency problems. Vyvanse is a prodrug, a substance that is inert until it is digested. This mimics how the body creates useful chemical and vitamins from our food. As Vyvanse only acts as a stimulant once it is broken down by the stomach you cannot get a high from grinding it up and snorting it. Swallowing higher than prescribed doses (150mg compared to the recommend max of 70mg) will still produce a high indistinguishable from that produced by a comparable dose of Ritalin.

Vyvanse: Four Times More Side Effects

Because Vyvanse is new it has only been used by those adults and children who took part in the drug’s trials. In total, less than 1000 people. With such a small sample (compared to the millions who will end up taking the drug) there is very little first hand knowledge of the drugs effects. With each of the other major drugs, Ritalin, Adderall etc, different people can have very different reactions to the drugs. Someone who is fine on one drug may have numerous side effects from a chemically very similar drug. The body and brain are very complex chemical systems and stimulants are a very crude tool.

Currently we only have the Vyvanse prescribing information to go on as a guide to its effects but one things is very noticeable. In trials 10% of users stopped taking the drug due to adverse effects (i.e. side effects). This is much higher than Adderall where only 2.4% of participants were effected. In the Adderall trials more people stopped using the placebo than the real drug but for Vyvanse only 1% of placebo users dropped out. The new drug has a side effect rate 10 times higher than the base line and four times high than Adderall.

Vyvanse And The $1.5 Billion Goal

Shire PLC are introducing this new drug as a replacement for Adderall XR whose patent is running out. They hope to capture 50% of the market share with the drug and as the market is worth $3 billion, a 50% share will generate a lot of money. Expect to see a lot of advertising aimed at parents, not doctors, when Vyvanse is launched in July. In theory Vyvanse is a lot cheaper to make than competing drugs as its chemical formula is its key rather than the complex release mechanisms used by others drugs. However I expect that Vyvanse will retail at about the same as the other ADHD medications at about $130 – $150 for a months dose.