Schizophrenia Pill For Teens Is Coming

6 Comments

abilify.jpgSo here’s a move that’s likely to cause controversy. Citing unmet medical needs, the FDA has agreed to grant priority review to an application from Bristol-Myers Squibb, which wants to sell its antipsychotic for teenagers.

This could become the first atypical antipsychotic drug to be approved for adolescents, although the whole class of meds is widely prescribed off-label to children of all ages, despite concerns the lack of studies in children and concern over side effects. With an FDA imprimatur, however, Bristol-Myers is poised to tap a whole new market without the stigma.

Lilly, which is being sued by eight states that claim the drugmaker hid side effects and engaged in off-label marketing, and Johnson & Johnson have also asked the FDA to clear their drugs for use in teenagers. However, Abilify sales rose 41 percent last year, the biggest increase among antipsychotics, helped by studies showing it caused less weight gain than competing drugs.

Drugmakers sold more than $15 billion in antipsychotic medicines last year, according to data compiled by Bloomberg News. About 15 percent of sales came from doctors writing so-called off-label prescriptions for unapproved uses such as treatment of teens, analysts say.

“i would expect Abilify to gain the most prescriptions from an approval for adolescent use because younger patients appear to be more susceptible to weight gain than adults,” says Jeffrey Lieberman, chairman of psychiatry at Columbia University in New York, who has received research grants from Bristol-Myers and other drugmakers.

“There’s no gold standard for treating schizophrenia in teens,” Les funtleyder, an analyst at Miller Tabak tells Bloomberg News, “and the first company to get FDA approval for this will have an edge in this very crowded market.”

Jump to comments

Share

Comments

  1. You have got to be kidding!! is this the “new Soup du jour”ARE THESE INDIVIDUALS DEMENTED!!!

    I TAKE IT, THAT HARMING THE ADULT POPULATION ISNT ENOUGH FOR THEM!!!!!

  2. Its great to have customers who can’t refuse.

  3. Haloperidol, not Olanzapine, Linked With Brain Shrinkage in Schizophrenia:By Roberta Friedman, PhD
    NEW ORLEANS, LA — November 11, 2003 — Haloperidol may exacerbate the shrinking of the brain that scientists are beginning to link with schizophrenia. Findings of a multi-center study comparing first- and second-generation treatment for schizophrenia were announced here November 9th at Neuroscience 2003, the Society for Neuroscience 33rd Annual Meeting

    Dr. Lieberman “Haloperidol is better than nothing,” he said, for patients with schizophrenia.

  4. Hey, gotta have something to take the edge off after the Ritalin, Adderall and Concerta.

  5. This is just,so sick….

  6. This is just, so sick….

Subscribe

RSS Feed

Comments feed for this post only.

Tags

, , , , ,

Clear

Clear

© 2007- 2008 Newark Morning Ledger Co.  All Rights Reserved.

Thanks for trying out the new Pharmalot printing tools. If you're got any suggestions for how we can help you print better, please let us know by clicking on the contact link at http://www.pharmalot.com/