A Randomized, Double-Blind, Double-Dummy, Placebo-, Active-Controlled, 4 Period, 4 Way Crossover Study to Evaluate the Abuse Potential of Manipulated Abuse-Deterrent Dextroamphetamine Sulfate Immediate Release (ADAIR) Formulation Compared to Dextroamphetamine Sulfate Immediate Release When Administered Intranasally to Nondependent, Recreational Stimulant Users

This is a randomized, double-blind, double-dummy, placebo- and active-controlled 4 period, 4 way crossover study to assess the intranasal abuse potential of manipulated ADAIR formulation in nondependent, recreational stimulant users. The study will consist of an outpatient Screening Visit, an in clinic Qualification Phase, an in-clinic Treatment Phase, and an outpatient Follow-Up visit.

Start Date05 Oct 2020

Sponsor / Collaborator

Vallon Pharmaceuticals, Inc.

NCT03659929

/ CompletedPhase 3

A Multicenter, Fixed-Dose, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of AR19 (Amphetamine Sulfate) in Adult Subjects (Ages 18-55) With Attention Deficit Hyperactivity Disorder (ADHD)

The purpose of the AR19.004 study is to assess the efficacy of AR19 compared to placebo using the Adult ADHD Investigator Symptom Rating Scale (AISRS)

Start Date18 Sep 2018

Sponsor / Collaborator

Arbor Pharmaceuticals, Inc.

NCT02884544

/ CompletedPhase 2

Phase II, Open-label, Dose-titration, Safety Study Designed to Determine the Evening Dose of a Novel Delayed and Extended Release Formulation of Dextroamphetamine Sulfate (HLD100) to Produce Optimal Clinical Effects in Children With ADHD

The phase 2 study will evaluate the safety, tolerability and efficacy of HLD100 at steady state (following up to 5 weeks of treatment) in children using an outpatient, single-center, open-label, flexible dose-escalation study design.

Start Date01 Aug 2016

Sponsor / Collaborator

Ironshore Pharmaceutical & Development, Inc.

100 Clinical Results associated with Amphetamine Sulfate

100 Translational Medicine associated with Amphetamine Sulfate

100 Patents (Medical) associated with Amphetamine Sulfate

18,292

Literatures (Medical) associated with Amphetamine Sulfate

01 Jun 2025·Food Chemistry

High-throughput screening of new psychoactive substances and related compounds in food by UHPLC-Q/Orbitrap

Article

Author: Wu, Wenlin ; Huang, Xia ; Liu, Shiyao ; Chen, Xiaoqi ; Zhou, Yan ; Wan, Yuping ; Xia, Bing ; Guo, Tianrong ; Shi, Peiyu ; Xiao, Quanwei ; Zhang, Min

Currently, there is concern about food products to which new psychoactive substances (NPS) have been added illegally. However, rapid, high-sensitivity, and high-throughput screening methods for such harmful substances have not been reported yet. In this study, a high-throughput non-targeted screening strategy was developed based on UHPLC-Q/Orbitrap. First, optimized pretreatment methods for typical high-risk matrices were established. Second, an accurate, efficient, and scalable high resolution mass spectrometry database containing 206 NPS and related compounds was constructed. The fragmentation pathways of three different types of fentanyl-related compounds were then systematically investigated to enhance compound identification. Additionally, a non-targeted screening strategy was developed using warning ions derived from 24 fentanyl-related compounds, streamlining the identification of NPS. This strategy was applied to 100 food samples with possible illegal additives and demonstrated its effectiveness. In summary, this study provides robust technical support for regulatory authorities in combating the illegal addition of food products.

01 May 2025·The Lancet Psychiatry

Comparative cardiovascular safety of medications for attention-deficit hyperactivity disorder in children, adolescents, and adults: a systematic review and network meta-analysis

Review

Author: Garcia-Argibay, Miguel ; Montastruc, François ; Del Giovane, Cinzia ; Farhat, Luis C ; Tomlison, Anneka ; Parlatini, Valeria ; Cipriani, Andrea ; Lannes, Alice ; Chang, Zheng ; Fava, Cristiano ; Cortese, Samuele ; Larsson, Henrik ; Revet, Alexis ; Ostinelli, Edoardo G

BACKGROUNDConcerns about the cardiovascular safety of medications used for the treatment of attention-deficit hyperactivity disorder (ADHD) remain. We aimed to compare the effects of pharmacological treatments for ADHD on haemodynamic values and electrocardiogram (ECG) parameters in children, adolescents, and adults.METHODSFor this systematic review and network meta-analysis, we searched 12 electronic databases, including Cochrane CENTRAL, Embase, PubMed, and the WHO International Clinical Trials Registry Platform, from database inception to Jan 18, 2024, for published and unpublished randomised controlled trials comparing amphetamines, atomoxetine, bupropion, clonidine, guanfacine, lisdexamfetamine, methylphenidate, modafinil, or viloxazine against each other or placebo. Primary outcomes were change in systolic blood pressure (SBP) and diastolic blood pressure (DBP), measured in mm Hg, and pulse, measured in beats per minute, at timepoints closest to 12 weeks, 26 weeks, and 52 weeks. Summary data were extracted and pooled in random-effects network meta-analyses. Certainty of evidence was assessed with the Confidence in Network Meta-Analysis (CINeMA) framework. This study was registered with PROSPERO, CRD42021295352. Before study initiation, we contacted representatives of a UK-based charity of people with lived experience of ADHD-the ADHD Foundation-regarding the relevance of the topic and the appropriateness of the outcomes chosen.FINDINGS102 randomised controlled trials with short-term follow-up (median 7 weeks [IQR 5-9]) were included, encompassing 13 315 children and adolescents (aged ≥5 years and <18 years; mean age 11 years [SD 3]; of available data, 9635 [73%] were male and 3646 [27%] were female; of available data, 289 [2%] were Asian, 1719 [15%] were Black, and 8303 [71%] were White) and 9387 adults (≥18 years, mean age 35 years [11]; of available data, 5064 [57%] were male and 3809 [43%] were female; of available data, 488 [6%] were Asian, 457 [6%] were Black, and 6372 [79%] were White). Amphetamines, atomoxetine, lisdexamfetamine, methylphenidate, and viloxazine led to increments in haemodynamic values in children and adolescents, adults, or both. In children and adolescents, mean increase against placebo ranged from 1·07 (95% CI 0·36-1·79; moderate CINeMA confidence) with atomoxetine to 1·81 (1·05-2·57; moderate) with methylphenidate for SBP; from 1·93 (0·74-3·11; high) with amphetamines to 2·42 (1·69-3·15; low) with methylphenidate for DBP; and from 2·79 (1·05-4·53; moderate) with viloxazine to 5·58 (4·67-6·49; high) with atomoxetine for pulse. In adults, mean increase against placebo ranged from 1·66 (95% CI 0·38-2·93; very low) with methylphenidate to 2·3 (0·66-3·94; very low) with amphetamines for SBP; from 1·60 (0·29-2·91; very low) with methylphenidate to 3·07 (0·69-5·45; very low) with lisdexamfetamine for DBP; and from 4·37 (3·16-5·59; very low) with methylphenidate to 5·8 (2·3-9·3; very low) with viloxazine for pulse. Amphetamines, lisdexamfetamine, or methylphenidate were not associated with larger increments in haemodynamic values compared with atomoxetine or viloxazine in either children and adolescents or adults. Guanfacine was associated with decrements in haemodynamic values in children and adolescents (mean decrease against placebo of -2·83 [95% CI -3·8 to -1·85; low CINeMA confidence] in SBP, -2·08 [-3 to -1·17; low] in DBP, and -4·06 [-5·45 -2·68; moderate] in pulse) and adults (mean decrease against placebo of -10·1 [-13·76 to -6·44; very low] in SBP, -7·73 [-11·88 to -3·58; very low] in DBP, and -6·83 [-10·85 to -2·81; very low] in pulse). Only four RCTs informed on effects in the medium term and none on the long term.INTERPRETATIONPractitioners should monitor blood pressure and pulse in patients with ADHD treated with any pharmacological intervention, and not stimulants only. Given the short duration of available randomised controlled trials, new research providing insights on the causal effects of ADHD medications on cardiovascular parameters in the longer term should be funded.FUNDINGNational Institute for Health and Care Research.

01 May 2025·Forensic Science International

Development, validation and applications of a GC/MS method for the simultaneous determination of 9 amphetamines and 12 NPS analogues in blood and urine

Article

Author: Nikolaou, Panagiota ; Athanaselis, Sotirios ; Bouzoukas, Christoforos ; Dona, Artemisia ; Papoutsis, Ioannis ; Spiliopoulou, Chara

Amphetamine-type stimulants (ATS), synthetic cathinones (SCs) and phenethylamines (PEAs) pose a challenge to toxicology laboratories. Their extensive use and misuse has led to an increase of intoxications and fatal incidents worldwide. So, the need for new analytical methods for their determination in biological samples is crucial for all toxicology laboratories for a better investigation of these cases. The aim of this study was the development and validation of an analytical method for the determination of 9 ATS, 7 SCs and 5 PEAs in whole blood and urine using gas chromatography coupled with mass spectrometry. The samples were pretreated by solid-phase extraction and derivatized with pentafluoropropionic anhydride. Chromatographic separation of the 21 analytes was achieved in less than 11 min. The method was validated according to international guidelines for selectivity, specificity, linearity, limits of detection (LODs) and quantification (LOQs), precision, accuracy and recovery of the method. The LODs of the analytes ranged from 0.70 to 7.0 ng/mL and the values of the LOQs ranged from 2.0 to 20 ng/mL. The linearity of the 21 analytes, according to the group of substances, were 2.0 ng/mL - 0.20 μg/mL, 5.0 ng/mL - 0.50 μg/mL, 10 ng/mL - 0.50 μg/mL and 20 ng/mL - 0.50 μg/mL with R² values > 0.99. Extraction recoveries were > 80 % for all analytes. Intra and inter day accuracy and precision of the method were within accepted limits. The developed method was applied to post-mortem blood and urine samples of 46 forensic cases sent for toxicological investigation to the Department of Forensic Medicine and Toxicology, School of Medicine, National and Kapodistrian University of Athens. The results of the analyses revealed the presence of methamphetamine, amphetamine, MDMA, MDA, pseudoephedrine, phenylpropanolamine or MBDB in 14 cases.

News (Medical) associated with Amphetamine Sulfate

16 Apr 2025

·www.prnewswire.com

Glenmark Pharmaceuticals Inc., USA to launch Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 10 mg, 15 mg, 20 mg and 30 mg

MAHWAH, N.J., April 16, 2025 /PRNewswire/ -- Glenmark Pharmaceuticals Inc., USA (Glenmark) is pleased to announce the upcoming launch[1] of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 10 mg, 15 mg, 20 mg and 30 mg. Glenmark's Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 10 mg, 15 mg, 20 mg and 30 mg is bioequivalent and therapeutically equivalent to the reference listed drug, Adderall®[2] Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, of Teva Women's Health, Inc. and the company will begin distribution in May 2025. According to IQVIA™ sales data for the 12-month period ending February 2025, the Adderall® Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg market[3] achieved annual sales of approximately $421.7 million*. Commenting on the launch, Marc Kikuchi, President & Business Head, North America, said, "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 10 mg, 15 mg, 20 mg and 30 mg is a highly prescribed medication in the United States. Glenmark is very pleased to be able to help alleviate the shortage this country has been facing with this upcoming launch." About Glenmark Pharmaceuticals Ltd. Glenmark Pharmaceuticals Ltd. (BSE: 532296) (NSE: GLENMARK) is a research-led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of cardio-metabolic, respiratory, dermatology and oncology. The company has 11 world-class manufacturing facilities spread across 4 continents, and operations in over 80 countries. Scrip 100 positions Glenmark amongst the Top 100 biopharmaceutical companies ranked by Pharmaceutical Sales in 2023; while Generics Bulletin places it in the Top 50 Generics and biosimilar companies ranked by sales in 2024. Glenmark's Green House Gas (GHG) emission reduction targets have been approved in 2023 by the Science Based Target initiative (SBTi), making it only the second pharmaceutical company in India to achieve this. The organization has impacted over 3.3 million lives over the last decade through its CSR interventions. For more information, visit . You can follow us on LinkedIn (Glenmark Pharmaceuticals) and Instagram (glenmark_pharma). References: 1. Glenmark's Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 5 mg, 10 mg, 15 mg, 20 mg and 30 mg is only approved for the indication(s) listed in Glenmark's approved label. 2. All brand names and trademarks are the property of their respective owners. 3. Market includes brand and all available therapeutic equivalents. Note: IQVIA data obtained by Glenmark is only available for all approved RLD indications. Glenmark's product is only approved for the indications listed in Glenmark's approved label and is not marketed for all RLD indications. *IQVIA™ National Sales Perspectives: Retail & Non-Retail, February 2025. Logo: For more information, please contact: Udaykumar Murthy [email protected] +91 9960377617 SOURCE Glenmark Pharmaceuticals Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

01 Apr 2025

·www.drugs.com

Prevalence of Prescription Stimulant Misuse High in U.S. Adults

TUESDAY, April 1, 2025 -- The prevalence of prescription stimulant misuse and prescription stimulant use disorder (PSUD) is high among U.S. adults aged 18 to 64 years, according to a study published online March 19 in JAMA Psychiatry . Beth Han, M.D., Ph.D., M.P.H., from the National Institutes of Health in Bethesda, Maryland, and colleagues conducted a cross-sectional survey study to examine trends in dispensed stimulants and prescription stimulants from 2019 through 2022, as well as the prevalence of misuse and PSUD. A total of 83,762 adults aged 18 to 64 years were sampled. The researchers found that 25.3 percent of those using prescription stimulants reported misuse and 9.0 percent had PSUD. Among those with PSUD, 72.9, 87.1, 42.5, and 63.6 percent solely used their own prescribed stimulants, used amphetamines, reported no misuse, and had mild PSUD, respectively. Higher prevalence ratios were seen for misuse and PSUD among those using amphetamines versus those using methylphenidate (3.1 and 2.2, respectively). Women aged 35 to 64 years had the largest increase in the number of individuals dispensed prescription stimulants, from 1.2 million in quarter 1 of 2019 to 1.7 million in quarter 4 of 2022. Compared with other sex- and age-specific subgroups, the prevalence of prescription stimulant misuse was lower among women aged 35 to 64 years using these medications (13.7 percent compared with 22.0 to 36.8 percent for men aged 35 to 64 years and women aged 18 to 25 years, respectively). "We found that among U.S. adults aged 18 to 64 years using prescription stimulants, one-fourth reported misuse, and nearly one-tenth had PSUD," the authors write. One author disclosed long-term stock holdings in General Electric, 3M Companies, and Pfizer, outside the submitted work.

Clinical Result

13 Mar 2024

·healthcare-digital.com

ADHD Drugs Linked With Lower Risk of Unnatural Death

The prevalence of ADHD among prison populations is believed to be around ten times that of the general population. Amphetimine-based drugs used to treat ADHD may cut fatality risk, suggests study published in JAMA, one of the world's most widely read medical journals Medicines used to treat children and adults with attention deficit/hyperactivity disorder (ADHD) reduce the higher-than-average risk for premature death, suggests a study in the world’s most widely distributed medical journal. Researchers in Sweden tracked 148,578 children and adults with ADHD. Within three months of being diagnosed, about 57% had started on medications. Within two years, 632 patients had died, the researchers reported. Overall, among every 10,000 individuals, mortality rates were 39.1% in the medication group compared with 48.1% in those not receiving treatment. The findings were reported in JAMA , the world’s most widely circulated international peer-reviewed general medical journal. More than half of the deaths were due to unnatural causes, such as accidental injuries, accidental poisoning, and suicide. After accounting for other risk factors, use of medication was associated with 21% lower odds of death from any cause, and 25% lower odds of death from unnatural causes, for males in particular, the researchers found. The short-term study was not a randomised trial, so it is unclear whether the use of medication explains the results and, if it does, whether the effect is seen over time. Also unclear, according to an editorial published with the study, is whether ADHD treatment reduces the risk of premature death directly by reducing impulsive behaviours, or indirectly by alleviating core symptoms of the disease. “Future research should investigate the potential relationship between ADHD symptom severity and mortality outcomes for those receiving medication treatment,” the editorial said. ADHD pharmas include Teva, Janssen & Noven ADHD affects 5.9% of young people and 2.5% of adults worldwide, according to the 2021 World Federation of ADHD International. The prevalence of ADHD among prison populations is believed to be around ten times that of the general population. An estimated 25% of adults in prison have ADHD, compared to 2.5% of adults in the general population ( Young & Cocallis, 2021 ). ADHD medicines are amphetamine-based. Amphetamine is a central nervous system stimulant, and is also used in the treatment of narcolepsy and obesity. It was discovered as a chemical in 1887 by Lazăr Edeleanu, and used as a drug in the late 1920s. The first amphetamine pharmaceutical was Benzedrine. Modern amphetamine-based medicines include Adderall ( Teva Pharmaceutical ), Concerta ( Janssen ), Daytrana ( Noven ), Dexedrine ( Cardinal Health ) and Dyanavel XR ( Tris Pharma ). Amphetamine is a tightly controlled pharmaceutical, due to the health risks associated with recreational use. About JAMA JAMA , first published in 1883. It is a member of the JAMA Network, a consortium of peer-reviewed, general medical and specialty publications. The online version is freely available to institutions in developing countries through the World Health Organization's HINARI program.

Clinical ResultClinical Study

100 Deals associated with Amphetamine Sulfate

External Link

KEGG	Wiki	ATC	Drug Bank
-	Amphetamine Sulfate	N06BA01	-

R&D Status

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed Manual	Not Applicable	-	-	Amphetamines	jxybvupxes(yievnphaot) = high doses of amphetamines (>30 mg dextroamphetamine equivalents) were associated with 5.28-fold increased odds of psychosis or mania. xcdrhquwjj (cgvlfcjwip )	Negative	01 Oct 2024
				Control
NCT03659929 (CTgov)	Phase 3	Attention Deficit Disorder With Hyperactivity	320	placebo (Placebo)	rlosiossjb(ckngnnhyps) = xxqiamtuff plexrcwvil (eifssudksk, uxmowehabt - bvxkgieejc) View more	-	03 Sep 2024
				Amphetamine Sulfate (Amphetamine Sulfate (20 mg/Day))	rlosiossjb(ckngnnhyps) = pcbpijxjpy plexrcwvil (eifssudksk, qrzpqcxljw - oixpbgsfvs) View more
ATS2023	Not Applicable	Multiple Organ Failure	-	Amphetamines	(htoqimznhw) = uwaznzxgnl rhbgbskbaw (qtucssluaa )	-	21 May 2023
NCT00715520 (CTgov)	Not Applicable	Stroke \| Brain Infarction \| Ischaemic cerebral infarction	33	Placebo+Methylphenidate+Amphetamine Sulfate+Carbidopa-Levodopa (Aim 1)	iusddsgwke(zrphqqlggs) = whqngrxwsd eilabosgsu (ulenxllrxt, eosggwzygf - cifihreuyy) View more	-	16 Oct 2017
				Transcranial Magnetic Stimulation (TMS) (Aim 2)	ltbqdoevnd(zkiorlzpxc) = pgkmfotunz pymwebsaol (icxrvhuatz, lykgmpeolf - qprfcllili) View more
NCT01986062 (CTgov)	Phase 4	Attention Deficit Disorder With Hyperactivity	97	AR11 (Amphetamine Sulfate) (AR11 (Amphetamine Sulfate))	bmkwttwcmy(nxiktxgnej) = pfknhqrpnf fibcpusnfb (duwmaovbog, ybzydloewm - faihamjakj) View more	-	19 Apr 2016
				Placebo (Placebo)	bmkwttwcmy(nxiktxgnej) = ecvpncrund fibcpusnfb (duwmaovbog, hxxrilqfoy - lolrhunxza) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis