Replies to post #441471 on Zeev's Turnips Patch-No Politics (ZEEV)

[madrose1]

Reports: FDA reverses on Noven ADHD drug
By Val Brickates Kennedy, MarketWatch

Last Update: 1:53 PM ET Dec. 2, 2005
Disable MW live quotes | E-mail it | Print | Alert | Reprint |

BOSTON (MarketWatch) - A drug reviewer for the Food and Drug Administration now says he believes Noven Pharmaceuticals' Daytrana patch should be approved, despite having written an opinion to the contrary in a memo released Thursday.


According to local reports, FDA drug reviewer Dr. Robert Levin told an agency advisory panel Friday that he now believes the Daytrana patch, which elutes the drug methylphenidate, should be approved to treat attention deficit hyperactivity disorder, ADHD, in children.

The advisory panel will issue a formal recommendation this afternoon on whether the product should be approved by the agency. While the FDA is not bound to its panels' decision, it generally abides by them.

Noven (NOVN:
Noven Pharmaceuticals Inc
News, chart, profile
Last: 11.17-2.34-17.32%

7:45am 12/02/2005

Add to portfolio
Analyst
Create alertInsider
Discuss
FinancialsMore NOVNNOVN11.17, -2.34, -17.3%) has been seeking to have the Daytrana patch approved since 2003.

Levin's reported statements on Friday are a reversal of what he wrote in his formal review of the product, which was posted on the FDA's website Thursday along with other briefing materials for the meeting. Levin was the FDA's lead reviewer for the product.

News of Levin's negative review drove down Noven shares by almost 20% on Thursday. Shares were halted Friday, pending the outcome of the meeting.

Methylphenidate is a stimulant that can cause insomnia, anorexia and weight loss, especially in higher doses. The drug is generally taken in pill form, marketed under such brand names as Ritalin, Methylin and Concerta.

In the FDA documents released Thursday, Levin said he believed the patch triggered more of the side effects associated with methylphenidate than pill versions of the drug. Because of this, he said he did not think Daytrana should be approved.

Noven first applied to have Daytrana approved in 2003, with a wear-time of 12 hours. The FDA rejected that application, stating the patch generated too many side effects, and suggested the company cut down the wear-time, according to the documents.

Noven resubmitted its application for Daytrana with a wear-time of 9 hours in June 2005. After reviewing additional studies submitted by the company, Levin determined the drug still generated too many side effects.

Noven has granted the worldwide marketing rights to Daytrana to Shire Pharmaceuticals Group (SHPGY: