« Nanogen, Inc. Acquired 6 Patents for Detection and Use of Biomarkers Related to Diabetes and Alzheimer’s disease | Main | Dendreon Corp. Partially Completes Rolling USFDA BLA of PROVENGE® as Treatment for Advanced Prostate Cancer Patients »

Aug28
Shire plc Submitted Guanfacine Extended Release NDA for the Treatment of ADHD in Children and Teens

Shire plc (LON: SHP, NASDAQ: SHPGY) has recently submitted a new drug application (NDA) to the USFDA for its investigational compound guanfacine extended release (previously referred to as SPD503), which when approved will become the first once-daily selective alpha-2A-adrenoceptor agonist for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6 to 17 years.

Shire’s proposed trade name for guanfacine extended release is CONNEXYN™. The said application is subject to a 10-month USFDA review period.

According to Matthew Emmens, Shire's Chief Executive Officer:

"The NDA submission of guanfacine extended release is another Shire milestone in the development of our ADHD portfolio, demonstrating further our ability to execute on our strategy for continued growth.

As the first selective alpha-2A-adrenoceptor agonist submitted to the FDA for the treatment of ADHD, CONNEXYN, if approved, would enhance our product portfolio as a new non-stimulant ADHD medication, reaffirming our commitment to the ADHD community in providing a range of effective treatment options for this disorder."

Shire plc has already initiated a Phase IIIb clinical trial to assess the safety and efficacy of guanfacine extended release in children with ADHD who also exhibit oppositional behavior, in its continued effort to develop the product.

Read the Shire press release.

related entries


0 Comments/Trackbacks




submit a trackback

TrackBack URL for this entry:

post a comment

Name, Email Address, and URL are not required fields.





Comment Preview

« Nanogen, Inc. Acquired 6 Patents for Detection and Use of Biomarkers Related to Diabetes and Alzheimer’s disease | Main | Dendreon Corp. Partially Completes Rolling USFDA BLA of PROVENGE® as Treatment for Advanced Prostate Cancer Patients »

Advertise

Watch the Digital Health Revolution


sponsored ads



subscribe


Prefer Email?
Subscribe below-

Enter your Email:


Powered by FeedBlitz What's this?

Current News

Support This Blog

top blogs

business social media

Use these fast growing business social media sites to promote your business, feature your products, spotlight your business leaders, create links, and drive traffic back to your company site, all for free!

BIZZlogos - Add your logo - free link to your site
BIZZphotos - Add photos of your products and people
BIZZprofiles - Submit your profile and build your online visibility
BIZZspotlight - Spotlight your business with free links
BIZZvideos - Videos about businesses, products and business people.
BIZZbites - "Digg" for Business - Submit your articles and posts

Know More Media - Health Care / Pharmaceutical / Fitness

know more media network

View Network Map

Network Feed List (OPML)

Know More Media Network
Feed


we support unitus

PRWeb

Influencer



PharmaGazette is a member of the Know More Media network of business related blogs.

Here are some current headlines from some of our business publications:

ProductivityGoal

CallCenterScript

AdHurl

TheBizofKnowledge

LandingTheDeal

CustomersAreAlways

HealthCareVox

BrainBasedBusiness

TheInsurancePolicy

MarketingBlurb