Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Shire/Noven Daytrana data

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Shire and Noven's Phase II study of ADHD methylphenidate transdermal system Daytrana, presented at the American Academy of Child & Adolescent Psychiatry in Toronto Oct. 20 & 21, shows a statistically significant improvement over placebo after 12 hours (p<0.001). Similar results to the 79-patient Phase II "classroom study" were seen in the 270-patient Phase III "naturalistic" trial measuring "overall symptoms," also reported at AACAP. The trials are included in Shire's June 28 resubmission for use in children ages six to 12 (1Pharmaceutical Approvals Monthly August 2005, In Brief). A Dec. 2 review is planned by FDA's Psychopharmacologic Drugs Advisory Committee...

You may also be interested in...



Shire resubmits methylphenidate patch

Shire and partner Noven's response to an April 2003 "not approvable" letter for their methylphenidate transdermal patch for attention deficit hyperactivity disorder has been accepted by FDA, the firms announce July 26. The NDA was resubmitted June 28. Included in the submission are two additional studies: a 270-patient Phase III trial and a 79-patient Phase II trial. Both studies were seven weeks and enrolled children between six and 12 years of age. The sponsors are seeking an indication for treatment of that age group in the new NDA. The product, formerly MethyPatch, would be the first methylphenidate product available in patch form...

WHO Stops Clinical Trials Involving Hydroxychloroquine And HIV Drugs

The WHO’s “Solidarity” trial investigators have decided to interrupt the trials with immediate effect since the clinical trial found that hydroxychloroquine and lopinavir/ritonavir “produced little or no reduction in the mortality of the hospitalized COVID-19 patients.”

Caplin Partners With Xellia For Five Injectables

With a pipeline of over 35 ANDAs, India's Caplin Steriles plans to launch five generic injectables through a strategic partnership with Xellia Pharma in the US market. Out of the five ANDAs, one has been approved and is ready for launch.

Topics

UsernamePublicRestriction

Register

PS140995

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel