I n this column I would like to make the readership aware of a recent update. The manufacturer of Focalin XR (Novartis Pharmaceuticals) recently announced that the Food and Drug Administration (FDA) recently approved labeling changes in the product's prescribing information. Interestingly, a maximum dosing was not listed, as has existed in previous iterations of labeling for this and other products in the stimulant medication class. The labeling does explain that doses in excess of 30 mg/day in pediatric-aged populations and 40 mg/day in adults have not been examined and are not recommended. The labeling does mention that there were no greater benefits on average for the higher doses when compared to lower doses. As mentioned last month, a new focus of this column is to examine certain studies in order to share pertinent details with our readership. The results of one of the studies, which contributed to the decision for this labeling change, was presented as a scientific poster at the 2009 American Academy of Child and Adolescent Psychiatry (Muniz R, Pestreich L, McCague K, Padilla A, Brams M, Childress A: Extended-release dexmethylphenidate 30 mg provides optimum control of ADHD symptoms up to 12 hours postdose: A randomized, double-blind, crossover study of children with ADHD).

In that 12 hour laboratory class room study, 162 children (ages 6 through 12 years old) were included in the treatment analyses. The study design was a crossover using placebo as well as 20 and 30 mg of dexmethlyphenidate, and sequencing was randomly assigned. Ratings were performed at hours 3, 6, 9, 10, 11, and 12 of the study. The primary measure was the SKAMP scale, which is the standard rating instrument used in most laboratory classroom studies. There are attention and deportment subscales, and these can be examined as a combined score as well. Not surprisingly, each of the agents was superior to placebo at all time points, but it is important to note where the specific differences were evident between the 20 and 30 mg doses. Interestingly, significant differences were not observed between the doses at hours 3 and 6 on any SKAMP measure. On the attention scale, significant differences emerged from hours 10 through 12. Significant differences in deportment were specifically noted only at hours 9 and 12. However, when the scores were combined, the magnitude of the differences were deemed statistically significant at each time point from hours 9 through 12. As a result, the labeling statement regarding on average higher doses not yielding greater benefits may require special understanding by clinicians for their individual patients. It seems that the most important clinical distinction between the doses may be for those who require greater coverage at the end of their day. In terms of side effects, about 28 percent of those on 30 mg experienced an adverse effect, compared to 22% while on 20 mg, and 18% when on placebo.

We are including an updated list of conferences for your consideration.

The 2010 Lifelong Learning Institute will be held in Seattle, WA, from March 26–27, 2010, contact (202) 966–7300.

The 35th Annual Review Course in Child and Adolescent Psychiatry and Training Session for the Oral Exams will be held in Cincinnati, OH, from April 21–24, 2010, contact (202) 966–7300.

The 2010 American Psychiatric Association meeting will be held in New Orleans, LA from May 22–26, 2010, contact (888) 357–7924.

The 2010 NCDEU meeting will be held in Boca Raton, FL from June 14–17, 2010, contact info@ncdeumeeting.org.

The 2010 Institute on Psychiatric Services meeting will be held in Boston, MA from October 14–17, 2010, contact (888) 357–7924.

The 57th Annual Meeting of the American Academy of Child and Adolescent Psychiatry will be held in New York, NY from October 26–31, 2010, contact (202) 966–7300.