A couple of months ago we reported that Shire Pharmaceuticals was looking to receive approval on their third medication for the treatment of ADHD named VYVANSE, and now they have received it from the FDA. This new medication will go along with Shire's two other products for ADHD, Daytrana, a methylphenadate patch worn by children on the hip, and the somewhat controversial ADDerall XR. All three products are once per day dosing.

The product is expected to be on the market by the summer of 2007, and is expected to generate a lot of money for Shire. In fact, Shire is so fond of stimulants for the treatment of ADHD that they paid $2,600,000,000 (yes, that's 2.6 Billion dollars) for New river Pharmaceuticals, the company that actually developed Vyvanse. Read more in the press release below about the new medication, the money, and the companies.

Press Release - VYVANSE - February 23, 2007

FOR IMMEDIATE RELEASE

Shire and New River Pharmaceuticals Announce FDA Approval of the First and Only Stimulant Prodrug VYVANSE (lisdexamfetamine dimesylate) as a Novel Treatment for ADHD.

The first long-term, large-scale study designed to determine the safety and effectiveness of treating preschoolers who have attention deficit/hyperactivity disorder (ADHD) with methylphenidate (Ritalin) has found that overall, low doses of this medication are effective and safe. However, the study found that children this age are more sensitive than older children to the medication's side effects and therefore should be closely monitored. The 70-week, six-site study was funded by the National Institutes of Health's National Institute of Mental Health (NIMH) and was described in several articles in the November 2006 issue of the Journal of the American Academy of Child and Adolescent Psychiatry.

"The Preschool ADHD Treatment Study, or PATS, provides us with the best information to date about treating very young children diagnosed with ADHD," said NIMH Director Thomas R. Insel, MD. "The results show that preschoolers may benefit from low doses of medication when it is closely monitored, but the positive effects are less evident and side-effects are somewhat greater than previous reports in older children."

Methylphenidate is the most commonly prescribed medication to treat children diagnosed with ADHD. But its use for children younger than 6 years has not been approved by the Food and Drug Administration. And until PATS, very few studies—and no large-scale ones—have been conducted to collect reliable, consistent data to help guide practitioners treating preschoolers with ADHD.

The 303 preschoolers enrolled in the study ranged in age from 3 to 5 years. The children and their parents participated in a pre-trial, 10-week behavioral therapy and training course. Only those children with the most extreme ADHD symptoms who did not improve after the behavioral therapy course and whose parents agreed to have them treated with medication were included in the medication study. In the first part of the medication study, the children took a range of doses from a very low amount of 3.75 mg daily of methylphenidate, administered in three equal doses, up to 22.5 mg/day. By comparison, doses for school-aged children usually range from 15 to 50 mg total daily.

The study then compared the effectiveness of methylphenidate to placebo. It found that the children taking methylphenidate had a more marked reduction of their ADHD symptoms compared to children taking a placebo, and that different children responded best to different doses.

Recently the National Institute of Mental Health reported on “the first long-term, large-scale study designed to determine the safety and effectiveness of treating preschoolers who have attention deficit/hyperactivity disorder (ADHD) with methylphenidate (Ritalin).” The study was published in the Journal of the American Academy of Child and Adolescent Psychiatry.

The study looked at 300 preschoolers, ages 3-5. The children had been diagnosed with ADHD and their families had all been in a 10-week behavior modification program first.

"The Preschool ADHD Treatment Study, or PATS, provides us with the best information to date about treating very young children diagnosed with ADHD," said NIMH Director Thomas R. Insel, MD. "The results show that preschoolers may benefit from low doses of medication when it is closely monitored, but the positive effects are less evident and side-effects are somewhat greater than previous reports in older children."

There are three key points to Dr. Insel’s quote:

1. Preschoolers may benefit -- from low doses -- if closely monitored;
2. But there are not a lot of positive benefits, and
3. The side-effects are worse then in older children