SHIRE ANNOUNCES FILING OF SPD465 FOR THE TREATMENT OF ADULT ADHD
Shire plc 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.
21 July 2006 – Basingstoke, UK and Philadelphia, US – 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® (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.
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
The Rise of Predictive Engagement Tools in Clinical Trials
November 22nd 2024Patient attrition can be a significant barrier to the success of a randomized controlled trial (RCT). Today, with the help of AI-powered predictive engagement tools, clinical study managers are finding ways to proactively reduce attrition rates in RCTs, and increase the effectiveness of their trial. In this guide, we look at the role AI-powered patient engagement tools play in clinical research, from the problems they’re being used to solve to the areas and indications in which they’re being deployed.
