Drugs / mixed amphetamine salts
mixed amphetamine salts
also known as
Adderall XR · MAS · MAS XR · Adderall · MAS IR · Mixed amphetamine salts extended release · SHP465 · SPD465 · +2 more
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT03893032 | Jul → Oct 2019 | — | United States Army Aeromedical Research Laboratory | Unknown | No outcome recorded |
| Phase 33 trials · 1 met primary | ||||||
| Phase 3 | NCT04240756 | Aug 2020 → May 2025 | attention deficit-hyperactivity disorder | University of Maryland, College Park | Completed | No outcome recorded |
| Phase 3 | NCT00393042 | Jan 2006 → Feb 2009 | attention deficit-hyperactivity disorder | Seattle Children's Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00150579 | Jan → Jun 2005 | attention deficit-hyperactivity disorder | Shire | Completed | Met primary |
| Phase 43 trials | ||||||
| Phase 4 | NCT03511976 | May 2018 → Oct 2023 | attention deficit-hyperactivity disorder | Florida International University | Withdrawn | No outcome recorded |
| Phase 4 | NCT00468143 | Aug 2007 → Jan 2009 | attention deficit-hyperactivity disorder | NYU Langone Health | Completed | No outcome recorded |
| Phase 4 | NCT00506727 | Aug 2003 → Jul 2004 | attention deficit-hyperactivity disorder | Shire | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07568574 | Mar 2026 → May 2028 expected | — | Enhanced Emirates Limited | Enrolling by invitation | No outcome recorded |
| — | NCT00712699 | Jun 2008 → Aug 2010 | attention deficit-hyperactivity disorder | Baystate Medical Center | Completed | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 2 | NCT01399827 Comparator | Feb 2012 → Nov 2017 | attention deficit-hyperactivity disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01074294 Background | Mar 2010 → Jun 2011 | attention deficit-hyperactivity disorder | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | Missed primary |
| Phase 4 | NCT00889915 Comparator | Apr → Dec 2009 | attention deficit-hyperactivity disorder | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT00228046 Background | Jan 2004 → Jul 2007 | attention deficit-hyperactivity disorder, conduct disorder, oppositional defiant disorder | Stony Brook University | Completed | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2017-01-19 | Takeda | Regulatory U.S. FDA Acknowledges Receipt of Shire’s New Drug Application for SHP465 for ADHD takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for SHP465, a long-acting, triple-bead, mixed amphetamine salts formulation. |
| 2016-11-29 | Takeda | Results Shire Announces Positive Topline Results of SHP465 Efficacy and Safety Study in Adults with ADHD takeda.com ↗
Topline results revealed the study met its primary endpoints for both doses of SHP465 (12.5mg and 37.5mg) administered once daily, indicating superiority over placebo in ADHD symptom improvement (p<0.001). |
| 2016-04-04 | Takeda | Results Shire Announces Positive Results of SHP465 Safety and Efficacy Study in Children and Adolescents with ADHD takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) today announces positive topline results from a four-week Phase 3, randomized, double-blind, multi-center, placebo-controlled, dose-optimization, safety and efficacy study, SHP465-305, in children and adolescents aged 6-17 years with Attention-Deficit/Hyperactivity Disorder (ADHD). |
| 2014-10-09 | Takeda | Regulatory Shire Provides Regulatory Update On SHP 465, Investigational Compound For ADHD In Adults takeda.com ↗
After a series of follow-up discussions, the FDA has now clarified that additional pediatric data would be required for resubmission of SHP 465. |
All press releases naming this drug 8 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | mixed amphetamine salts | “Triple-bead mixed amphetamine salts (SPD465), a novel, enhanced extended-release amphetamine formulation for the treatment of adults with ADHD: a randomized, double-blind,...” PMID 19012813 ↗ Sep 200812“adults with attention-deficit/hyperactivity disorder (ADHD) treated with 3 times daily (TID) mixed amphetamine salts immediate release (MAS IR) versus once-daily (qAM) MAS...” PMID 21904088 ↗ Sep 2011 “Students will receive either a long-acting methylphenidate preparation or a long-acting mixed amphetamine salts preparation based on parent consultation with the study physician.” NCT03511976 ↗ “This study will evaluate the safety and effectiveness of extended release mixed amphetamine salts in treating preschool children with attention deficit hyperactivity disorder.” NCT00712699 ↗ “Mixed amphetamine salts or Dexmethylphenidate hydrochloride (HCL) or Methylphenidate HCl or Lisdexamfetamine dimesylate as per standard of care.” NCT01074294 ↗ “Mixed Amphetamine Salts” NCT01399827 ↗ |
| Known as | Adderall | “Mixed amphetamine salts (Adderall)” NCT07568574 ↗ |
| Known as | Adderall XR | “A Randomized Controlled Trial of Methylphenidate Transdermal System (Daytrana), Lisdexamfetamine Dimesylate (Vyvanse), OROS MPH (Concerta), and Mixed Amphetamine Salts Extended...” NCT00889915 ↗1“Mixed amphetamine salts (ADDERALL XR)” NCT00506727 ↗ |
| Known as | MAS | “Therefore, we examined the influence of baseline sleep quality on the effects of SHP465 mixed amphetamine salts (MAS) extended-release.” PMID 31228031 ↗ Jul 20191“Extended release mixed amphetamine salts (MAS)” NCT04240756 ↗ |
| Known as | MAS IR | “adults with attention-deficit/hyperactivity disorder (ADHD) treated with 3 times daily (TID) mixed amphetamine salts immediate release (MAS IR) versus once-daily (qAM) MAS...” PMID 21904088 ↗ Sep 2011 |
| Known as | MAS XR | “adults with attention-deficit/hyperactivity disorder (ADHD) treated with 3 times daily (TID) mixed amphetamine salts immediate release (MAS IR) versus once-daily (qAM) MAS...” PMID 21904088 ↗ Sep 20111“Mixed amphetamine salts extended release (MAS XR; Adderall XR) and atomoxetine (Strattera) were compared” PMID 16371674 ↗ Aug 2005 |
| Known as | Mixed amphetamine salts extended release | “Mixed amphetamine salts extended release” NCT00889915 ↗ |
| Known as | SHP465 | “Therefore, we examined the influence of baseline sleep quality on the effects of SHP465 mixed amphetamine salts (MAS) extended-release.” PMID 31228031 ↗ Jul 2019 |
| Known as | SPD465 | “Triple-bead mixed amphetamine salts (SPD465), a novel, enhanced extended-release amphetamine formulation for the treatment of adults with ADHD: a randomized, double-blind,...” PMID 19012813 ↗ Sep 2008 |
| Known as | triple-bead mixed amphetamine salts | “Triple-bead mixed amphetamine salts (SPD465), a novel, enhanced extended-release amphetamine formulation for the treatment of adults with ADHD: a randomized, double-blind,...” PMID 19012813 ↗ Sep 2008 |
| Known as | XR-MAS | “Extended release mixed amphetamine salts (XR-MAS), a stimulant medication, is a commonly prescribed and approved medication for treating ADHD in children 6 years and older.” NCT00712699 ↗ |
| Route | Oral | “oral, once-daily, enhanced extended-release amphetamine formulation” PMID 19012813 ↗ Sep 2008 |