View Full Version : Shire Files NDA for SPD465 (16-hour Adderall) for adults

07-28-06, 10:20 AM


21 Jul 2006 - Basingstoke, UK and Philadelphia, US – July 21, 2006 – Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for SPD465, an investigational amphetamine compound for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in the adult population. The application is subject to a 12-month FDA review period. SPD465 has the same active ingredient as ADDERALL XR<sup>®</sup> (mixed salts of a single-entity amphetamine product), but is designed to provide ADHD symptom control for up to 16 hours. Upon approval, this novel product will be the first and only ADHD stimulant product that controls inattention, hyperactivity and impulsivity for up to 16 hours.

“The FDA filing for SPD465 is another milestone met and underscores Shire’s commitment to be the market leader in ADHD treatments by offering patients new solutions to manage this chronic disorder,” said Matthew Emmens, Shire Chief Executive Officer. “If approved, the 16-hour formulation of SPD465 would make it the longest-acting stimulant medication for adult patients with ADHD, while also providing the efficacy of ADDERALL XR, the most prescribed brand of ADHD treatment.”

ADHD is a neurological brain disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than typically observed in individuals at a comparable age and maturity level. Scientists now agree that up to 65 percent of adolescents with ADHD will continue to have the ADHD diagnosis as adults. More than 9 million American adults currently exhibit symptoms of ADHD, based on independent research by the National Institute of Mental Health. Approximately 36 percent of ADHD prescriptions are currently written for adult patients.

07-28-06, 10:34 AM
Very interesting. I wonder how much more difficult it might be to fall asleep at the end of the day???

07-28-06, 07:57 PM
That would be great!

05-20-07, 10:24 PM
SPD495 was approved yesterday (may 19th).

05-22-07, 09:26 PM
Good to hear.

I took Adderall XR for about one week. It only lasted 7.5 hours !!

05-30-07, 09:49 PM
it was approved?!?! can i talk to my doc about using it?!?!!

05-30-07, 10:52 PM
No, its not approved, it's got an approvable letter, I wrote thsi pretty early, and I didn't pay attention to that little detail,

On Shire's calendars it has SPD465 schedualed to launch in 2008 with a *

Currently under review due to New River acquisition
Launch timing subject to review

05-31-07, 04:40 PM
meds have this half life thing,

and apparently meds stay in circulation for longer than, to expect.

as in 'blood circulation'

like, probably, an xr can last for 24 hours (to some affect), buh'' highfeelings only stay for about 7 hours if that.

uhh, need to leave this computer in a few mins, have to go, adios

and after awhile, no more high feelings, but affects do continue (ADHD wise) not stoner wise