Psychiatric Drugs: The New Pharmacopoeia

Newsweeks' April 25th issue has an article that investigates the pros and cons of the psychiatric drugs on the market today to treat ADHD.

Dr. Steven Scholzmann summarize the balancing act as follows:

"We can't dismiss the dangers of these drugs—but we must also respect the dangers of the illnesses themselves. Kids with untreated ADHD lag behind kids on medication—both at school and in their emotional and physical development. They also have high rates of substance abuse. And untreated mood and anxiety disorders are major risk factors for suicide, the third leading cause of death in young people."

Newsweek article: Psychiatric Drugs: The New Pharmacopoeia

ADHD Skin Patch

Source: Shire Pharmaceuticals Marketing Dept.

Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) today announced positive preliminary results from clinical trials of its methylphenidate transdermal system* (MTS) which is being developed in conjunction with Noven Pharmaceuticals Inc. for children with attention deficit and hyperactivity disorder (ADHD).

These trial results will be included as part of an amendment to the New Drug Application for the product currently pending at the FDA. Both Shire and Noven believe that the studies will address the issues raised by the FDA's review in April 2003. The FDA has previously confirmed that the amendment will be reviewed within six months after submission.

The two studies, a phase 2 study involving 79 patients over a seven week period and a phase 3 study involving 268 patients over a seven week period, examined MTS in children between the ages of 6 and 12 previously diagnosed with ADHD. In these studies, use of MTS was well tolerated and the objectives of both studies were achieved.

ADHD drug enters phase II tests

Saegis' lead compound enters phase II in ADHD

Memory and cognition-focused biopharmaceutical firm Saegis Pharmaceuticals has initiated a phase II clinical study of its lead product candidate, SGS742, in adult ADHD patients

The phase II trial is a placebo-controlled, double-blind crossover study, where patients will be randomized to receive either placebo or active drug, and then crossed over to the alternate agent. The trial will measure improvement in standard ADHD scales, and is expected to be completed in Q3 2005.

"In preclinical and clinical studies, SGS742 has consistently shown positive benefits on the ability to improve attention, learning and memory," said Dr Rodney Pearlman, president and CEO of Saegis. "We are excited to be conducting an efficacy study among the adult ADHD population where safe, non-stimulatory medicines are needed."

Source: Saegis Marketing Release/Press Release

AMA says Doctors May Over-Prescribe Drugs

The Australian Medical Association (AMA) has admitted there is a possibility that some doctors are over-prescribing ADHD medication to Western Australian children.

Figures from the Health Insurance Commission have revealed the drug dexamphetamine was prescribed to patients aged under 20 at four times the rate of other states last year.

Ritalin has Similar Effect for Children with Reading Disorders

The drug methylphenidate (brand name Ritalin) increased activity in brains of children with attention-deficit/hyperactivity disorder (ADHD) as well as those with a reading disorder, researchers at Yale report in the American Journal of Psychiatry.

"During a test of divided attention, Ritalin increased activation in the basal ganglia, a structure of the brain involved in cognition and behavior," said first author Keith Shafritz, former graduate student in the interdepartmental Neuroscience Program at Yale and now a research associate at Duke University Medical Center. "We saw this activation in children with ADHD and those with reading disorder."

FDA Warning on Strattera for ADHD

The Food and Drug Administration (FDA) is advising health care professionals about a new warning for Strattera, a drug approved for attention deficit hyperactivity disorder (ADHD) in adults and children. The labeling is being updated with a bolded warning about the potential for severe liver injury following two reports (a teenager and an adult) in patients who had been treated with Strattera for several months, both of whom recovered.

The labeling warns that severe liver injury may progress to liver failure resulting in death or the need for a liver transplant in a small percentage of patients. The labeling also notes that the number of actual cases of severe liver injury is unknown because of under-reporting of post-marketing adverse events.