Drugs / SHP465
SHP465
English name mixed amphetamine salts extended-release
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | attention deficit-hyperactivity disorder | 2017-01-19 | “Food and Drug Administration (FDA) has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for SHP465” takeda.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03327402 | Mar → Oct 2018 | attention deficit-hyperactivity disorder | Shire | Completed | No outcome recorded |
| Phase 1 | NCT02578030 | Oct → Nov 2015 | attention deficit-hyperactivity disorder | Shire | Completed | No outcome recorded |
| Phase 34 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT03325894 | Jan 2018 → Jan 2019 | attention deficit-hyperactivity disorder | Shire | Terminated | No outcome recorded |
| Phase 3 | NCT03325881 | Dec 2017 → Jun 2018 | attention deficit-hyperactivity disorder | Shire | Completed | Missed primary |
| Phase 3 | NCT02604407 | Nov 2015 → Mar 2016 | attention deficit-hyperactivity disorder | Shire | Completed | Met primary |
| Phase 3 | NCT02466425 | Jun 2015 → Feb 2016 | attention deficit-hyperactivity disorder | Shire | Completed | Met primary |
News releases announcing trial results or a regulatory action · 5
| 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 ↗
Lexington, Mass., USA – January 19, 2017 –– 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). |
| 2015-04-06 | Takeda | Regulatory Shire Announces Clear Regulatory Path Forward for SHP465 for Adults with ADHD takeda.com ↗
Shire plc (LSE: SHP, NASDAQ: SHPG) today announces that it has reached an agreement with the U.S. Food and Drug Administration (FDA) on a clear regulatory path for SHP465 (triple-bead mixed amphetamine salts - MAS), an investigational oral stimulant medication being evaluated as a potential treatment for Attention-Deficit/Hyperactivity Disorder (ADHD) in adults. |
| 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 5 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SHP465 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03325881 ↗ |
| Known as | MAS | “The objective of this randomized, double-blind, placebo-controlled study was to evaluate the efficacy and safety of SHP465 mixed amphetamine salts (MAS) in adults with...” PMID 28712074 ↗ Aug 20171“The aim of this study was to evaluate the efficacy, safety, and tolerability of SHP465 mixed amphetamine salts (MAS) in children and adolescents with...” PMID 28816509 ↗ Aug 2017 |
| Known as | mixed amphetamine salts | “The objective of this randomized, double-blind, placebo-controlled study was to evaluate the efficacy and safety of SHP465 mixed amphetamine salts (MAS) in adults with...” PMID 28712074 ↗ Aug 20172“The aim of this study was to evaluate the efficacy, safety, and tolerability of SHP465 mixed amphetamine salts (MAS) in children and adolescents with...” PMID 28816509 ↗ Aug 2017 “We aimed to evaluate the pharmacokinetics, safety, and tolerability of SHP465 mixed amphetamine salts (MAS) 6.25 mg after multiple once-daily doses in children aged 4-5 years with ADHD.” PMID 34826114 ↗ Nov 2021 |
| Known as | mixed amphetamine salts extended-release | “A Phase 3, Randomized Double-Blind Study of the Efficacy and Safety of Low-Dose SHP465 Mixed Amphetamine Salts Extended-Release in Children with Attention-Deficit/Hyperactivity...” PMID 33185468 ↗ Oct 2020 |
| Known as | SHP465 MAS | “This study evaluated the efficacy, tolerability, and safety of 6.25 mg SHP465 MAS once daily (one-half the lowest approved dose for adolescents and adults) versus placebo in...” PMID 33185468 ↗ Oct 20201“METHODS: In this open-label multicenter study, SHP465 MAS 6.25 mg once daily was administered for 28 days to children aged 4-5 years with ADHD;” PMID 34826114 ↗ Nov 2021 |
| Route | Oral | “SHP465 capsule 6.25 mg orally once daily for 4 weeks” NCT03325881 ↗ |