Delving into the Latest Updates on Amphetamine with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(+-)-alpha-Methylphenylethylamine, 1-phenyl-2-aminopropane, Adzenys XR-ODT

+ [14]

Target

TAAR1

Mechanism

TAAR1 agonists(Trace amine-associated receptor 1 agonists), Central nervous system stimulants

Therapeutic Areas

Other Diseases

Active Indication

Attention Deficit Disorder With HyperactivityPsychotic Disorders

Inactive Indication-

Originator Organization

Neos Therapeutics, Inc.

Active Organization

The Howard Hughes Medical Institute

Neos Therapeutics, Inc.

Inactive Organization

Tris Pharma, Inc.

Drug Highest PhaseApproved

First Approval Date

US (27 Jan 2016),

Attention Deficit Disorder With Hyperactivity

Regulation-

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Structure

Molecular FormulaC9H13N

InChIKeyKWTSXDURSIMDCE-UHFFFAOYSA-N

CAS Registry300-62-9

This study is a pragmatic clinical trial examining the comparative effectiveness of two stimulant medications (methylphenidate and amphetamine) in the treatment of ADHD in children and adolescents with autism. Using a sequential, multiple assignment randomization trial (SMART) design the study will not only assess these two medications but also the role of an increasingly popular class of ADHD medication, the alpha-2 agonists. Findings from this study will help improve clinicians' approach to medication selection and reduce the repeated trials of multiple medications that are current standard care.

Start Date01 Oct 2023

Sponsor / Collaborator

Nationwide Children's Hospital

[+13]

IRCT20210525051403N1 / RecruitingPhase 2/3IIT

Mindfulness Based Relapse Prevention Therapy in Individuals with Amphetamine Use Disorder

Start Date10 Jun 2021

Sponsor / Collaborator-

100 Clinical Results associated with Amphetamine

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100 Translational Medicine associated with Amphetamine

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100 Patents (Medical) associated with Amphetamine

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18,305

Literatures (Medical) associated with Amphetamine

01 Jan 2025·Behavioural Brain Research

Environmental enrichment and sex, but not n-acetylcysteine, alter extended-access amphetamine self-administration and cue-seeking

Article

Author: Cain, Mary E ; Azuma, Miki C ; Fort, Troy D ; Laux, Dylan A

There are no approved therapeutics for psychostimulant use and recurrence of psychostimulant use. However, in preclinical rodent models environmental enrichment can decrease psychostimulant self-administration of low unit doses and cue-induced amphetamine seeking. We have previously demonstrated that glutamate-dependent therapeutics are able to alter amphetamine seeking to amphetamine-associated cues only in enriched rats. In the current experiment, we will determine if enrichment can attenuate responding and cue-induced amphetamine seeking during extended access to a high dose of intravenous amphetamine. We will also determine if N-acetylcysteine (NAC), a glutamate dependent therapeutic, can attenuate amphetamine seeking in differentially reared rats. Female and male Sprague-Dawley rats were reared in enriched, isolated, or standard conditions from postnatal day 21-51. Rats were trained to self-administer intravenous amphetamine (0.1 mg/kg/infusion) during twelve 6-hour sessions. During the abstinence period, NAC (100 mg/kg) or saline was administered daily. Following a cue-induced amphetamine-seeking test, astrocyte densities within regions of the medial prefrontal cortex (mPFC) and nucleus accumbens (ACb) were quantified using immunohistochemistry. Environmental enrichment decreased responding for amphetamine and during the cue-induced amphetamine-seeking test. NAC did not attenuate cue-induced amphetamine seeking or alter astrocyte density. Across all groups, female rats self-administered less amphetamine but responded more during cue-induced amphetamine seeking than male rats. While amphetamine increased astrocyte densities within the ACb and mPFC, it did not alter mPFC astrocyte densities in female rats. The results suggest that enrichment can attenuate responding during extended access to a high dose of amphetamine and the associated cues. Sex alters amphetamine-induced changes to astrocyte densities in a regionally specific matter.

01 Dec 2024·Journal of Substance Use and Addiction Treatment

California's Recovery Incentives Program: Implementation strategies

Article

Author: Trupiano, Dominic ; Peck, James A ; Thompson, Caitlin ; Loya, Carissa ; Freese, Thomas E ; Rawson, Richard ; Cooper, Madelyn ; Rawson, Richard A ; Rutkowski, Beth A. ; Datrice, Adrienne ; Padwa, Howard ; Peck, James A. ; Rutkowski, Beth A ; Freese, Thomas E. ; Simmons, Julian

INTRODUCTIONDue to the increasing role of psychostimulants in the US drug poisoning crisis, there is an increasing need to effectively implement evidence-based treatment for individuals with stimulant use disorder (StimUD). Contingency management is a behavioral strategy with robust evidence of support for the treatment of StimUD. In 2023, California initiated a large-scale effort to implement CM as a treatment for individuals with a stimulant use disorder (cocaine, methamphetamine, amphetamine) called the Recovery Incentives Program: California's Contingency Management Benefit.METHODSThe Recovery Incentives Program is being systematically implemented using the Becker et al. Science to Service Lab (SSL) implementation approach with several augmentations for this project. The SSL features three core components: didactic training, performance feedback, and external facilitation. We have augmented this approach with a readiness assessment process for sites prior to CM service launch, and an ongoing fidelity monitoring and feedback component post-launch.RESULTSThe present paper is a preliminary report describing the use of this augmented SSL strategy for CM implementation in a large-scale implementation effort. Data are presented to describe the implementation activities during the first ten months of the Recovery Incentives Program.CONCLUSIONThe California Recovery Incentives Program has been systematically implemented and appears to be receiving a positive response from treatment program staff and enrolled members. Future papers and evaluation reports will continue to document member response to the Program and report on the ongoing training and implementation process.

15 Nov 2024·Journal of Analytical Toxicology

Four-year evaluation of drug-impaired driving drug concentrations

Article

Author: Cieri, Grace ; Logan, Barry K ; Mohr, Amanda L.A ; Chan-Hosokawa, Aya ; Fogarty, Melissa

AbstractDrug-impaired driving is a significant public health and safety concern in the USA. To help assess current patterns of drug use in drivers, we evaluated 4 years of drug positivity in a large cohort of suspected impaired drivers. Samples collected between January 2017 and December 2020 were tested via a method compliant with the National Safety Council’s Alcohol, Drugs, and Impairment Division’s Tier I scope of recommended drugs. In 2017, NMS Labs received 17 346 driving under the influence of drugs cases, 17 471 in 2018, 19 050 in 2019, and 16 539 in 2020. The most common drug class detected was cannabinoids in ∼50% of the cases each year. The most common drugs detected over the 4 years were delta-9 tetrahydrocannabinol (delta-9 THC), ethanol, amphetamine/methamphetamine, fentanyl, and alprazolam. Delta-9 THC increased in positivity over the study, having been identified in 45% of cases in 2017, 46% in 2018, 46% in 2019, and 49% in 2020. Ethanol was found in 59% of cases in 2017, 59% in 2018, 61% in 2019, and 53% in 2020. Delta-9 THC and ethanol were the most common drug combination, found together in ∼19% of the cases every year of the study. Statistically significant increases in the average concentration of the following drugs were observed: fentanyl (5.7 ng/mL in 2017 to 9.6 ng/mL in 2020), methamphetamine (301 ng/mL in 2017 to 381 ng/mL in 2020), and delta-9-THC (6.4 ng/mL in 2017 to 7.3 ng/mL in 2020). Other findings included increases in the maximum reported concentrations between 2017 and 2020 for amphetamine (1400 to 2700 ng/mL), methamphetamine (5550 to 13 000 ng/mL), and fentanyl (56 to 310 ng/mL). Statistically significant concentration decreases were noted for several central nervous system depressants, notably prescription benzodiazepines, and several prescription narcotic analgesics.

85

News (Medical) associated with Amphetamine

24 Oct 2024

·www.prnewswire.com

Montana: A Trailblazer in Eliminating Regulatory Barriers for Opioid Use Disorder Treatment, According to Community Medical Services

HELENA, Mont., Oct. 24, 2024 /PRNewswire/ -- When the Substance Abuse and Mental Health Services Administration (SAMHSA) updated their recommendations governing Opioid Treatment Programs (OTPs) in April 2024, Montana was among the first to implement significant changes for OTPs in the state. Community Medical Services (CMS) currently provides care to Montana residents at 4 clinics, (Billings, Bozeman, Kalispell and Missoula), and has been working to adjust their clinical guidance to institute these changes aimed at improving patient safety and retention in treatment programs. This is a crucial step forward in addressing the opioid epidemic, providing more effective care for individuals struggling with opioid use disorder. Extended Take-Home Doses Under the new rules, patients are no longer required to come to a clinic at the same frequency as they have historically needed to. Medical providers can determine the appropriate number of take-home doses based on individual patient needs and criteria, including: Absence of active substance use disorders or other health conditions that increase the risk of patient harm Regular attendance for supervised medication administration Absence of serious behavioral problems Absence of known recent diversion activity Safe transportation and storage of take-home medication Higher Initial Dosing The initial dose of methadone, which was historically capped on the first day, can now be titrated more quickly at the medical provider's discretion, allowing patients with higher opioid tolerance to get to a therapeutic dose more quickly. This change acknowledges the varying levels of opioid tolerance among patients, exacerbated by the increased presence of fentanyl in the illicit drug supply, and enables medical providers to tailor treatment to individual needs. Drug Screens The presence of unprescribed amphetamine or cocaine on drug screen results will no longer be the sole limiting factor to requiring patients to not have to come into clinics daily, unless it increases the risk of overdose. This change recognizes that patients with opioid use disorder may also struggle with other substance use disorders and requires medical providers to assess each patient's unique situation. Conclusion The SAMHSA Final Rule changes mark a crucial step forward in enhancing Opioid Treatment Programs in Montana. By providing more flexible and individualized treatment options, these changes aim to improve patient safety and retention, decrease daily patient volumes at clinics, and ultimately support individuals in their journey towards recovery. How CMS is Implementing SAMHSA's Changes At its 4 clinics in Montana, CMS has proactively implemented the SAMHSA Final Rule changes. Our approach focuses on balancing patient safety with reducing barriers to treatment, ensuring that any changes benefit our patients and their recovery outcomes. Triweekly dosing—allowing patients to come to the clinic only three times per week—has become the new standard. This means that most patients, even those who might test positive for stimulants or miss some clinic days, are not required to visit the clinic more than three times a week. For patients who meet certain stability criteria, the option to advance to weekly clinic visits is available after just two weeks of triweekly dosing. This provides immense relief to patients who previously struggled to balance daily trips to the clinic with their other responsibilities, such as work or family. Visit the CMS blog on our website for a complete review by our Chief Science Officer, Dr. Robert Sherrick, of how we are taking an active step toward implementing these changes and seeing early positive results Media Contact: John Koch- Director Public Relations [email protected] 2827 Fort Missoula Rd, Missoula, MT 59804 8707 Jackrabbit Ln Suite D, Belgrade, MT 59714 2415 S Catlin St, Missoula, MT 59801 795 Sunset Blvd F, Kalispell, MT 59901 2040 Rosebud Dr, Billings, MT 59102 2827 Fort Missoula Rd, Missoula, MT 59804 SOURCE Community Medical Services WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

04 Sep 2024

·www.fiercepharma.com

DEA raises production limits on Takeda's ADHD drug Vyvanse and generics as shortages continue

To address an ongoing shortage of ADHD drugs, the Drug Enforcement Administration has increased the production quota on Takeda's Vyvanse and its generic versions by 24%. Less than four months after Teva’s Adderall was erased from the FDA shortage list, supply problems with another attention-deficit/hyperactivity disorder (ADHD) treatment, Takeda’s Vyvanse and its generic versions, are such that the U.S. Drug Enforcement Administration (DEA) has increased (PDF) production quotas on the drug by 24%.The move comes eight weeks after an FDA request to the DEA to bump up production limits. As Schedule 2 controlled substances, Vyvanse (lisdexamfetamine) and Adderall (amphetamine/dextroamphetamine) are subject to DEA limitations that help prevent them from being abused.The DEA has raised the aggregate production quota on lisdexamfetamine by 6,236 kilograms, according to a final order set to be published Thursday in the Federal Register. Of that figure, 1,558 kg has been allocated to domestic demand for medications, while the remaining 4,678 kg addresses foreign demand for the products.“These adjustments are necessary to ensure that the United States has an adequate and uninterrupted supply of lisdexamfetamine to meet legitimate patient needs both domestically and globally,” the DEA wrote in its notice. Because the drugs are so tightly controlled, there is a ripple effect when one has a supply issue. Shortages of ADHD drugs have persisted since the summer of 2022 when a labor problem on Teva’s packaging line reduced the supply of Adderall. That issue then triggered increased demand and supply issues with most of the 11 companies making generic versions of Adderall, including Sandoz, Amneal and Sun Pharma. Then, in June of last year, Takeda reported in a statement on its website that it was experiencing “low inventory” for Vyvanse brought on by increased demand and a manufacturing delay. In addition, the timing of Vyvanse's shortage raises a question around the economics of producing the medicine in the aftermath of generic launches. Takeda reported its Vyvanse supply shortfall last June, and the first U.S. generics ⁠launched two months later. Lawmakers and industry watchers have repeatedly flagged that ⁠economic factors can drive drug shortages when companies don't see a potential profit motive in dedicating their manufacturing equipment to low-margin—or even loss-making—products. Meanwhile, on the DEA's manufacturing allocation, the agency last summer committed to “reviewing and improving” the quota process. In 2022, that limit was not met, and drugmakers sold only 70% of their allotted quota for the year, making for some 1 billion extra doses that could have been produced, the FDA and the DEA revealed in a joint letter (PDF).At the time, the agencies said they had called on manufacturers to confirm production increases and asked that those that opt to no longer produce the meds “relinquish” their remaining quota so the DEA can redistribute it.

Biosimilar

28 Jun 2024

·www.pharmaceutical-technology.com

US Justice Dept cracks down on healthcare fraud schemes linked to $2.75bn loss

General Merrick Garland announcing the results of a nationwide healthcare fraud investigation at a 27 June press conference at the US Department of Justice. Credit: Samuel Corum via Shutterstock. The US Justice Department has charged 193 people in a major enforcement action, accusing them of participating in healthcare fraud schemes worth $2.75bn. The two-week crackdown involved 76 doctors, nurses, and other medical professionals. The defendants are accused of several scams, such as illegally distributing millions of Adderall (amphetamine) pills and other stimulants. This also included fraudulent activity that involved corporate executives distributing tainted and misbranded HIV medication, which amounted to $90m in losses. Ruthia He, founder and CEO of San Francisco-based digital technology company Done Global, was arrested on 13 June. He has been charged with participating in a scheme to distribute Adderall (amphetamine / dextroamphetamine) over the internet and conspired to commit healthcare fraud in connection with the submission of fraudulent claims for reimbursement for the drug and other stimulants. Adderall is a drug used to treat attention deficit hyperactivity disorder (ADHD). Also included in this crackdown were three executives of a pharmaceutical distributor who allegedly bought HIV medications through fraudulent schemes and resold them with falsified documents to pharmacies nationwide. This led to patients unknowingly receiving mislabelled drugs, one of whom fell unconscious for 24 hours after taking the wrong medication. Attorney General Garland said in a statement: “It does not matter if you are a trafficker in a drug cartel or a corporate executive or medical professional employed by a healthcare company. If you profit from the unlawful distribution of controlled substances, you will be held accountable.” See Also: CHMP recommends authorisation for Pfizer-BioNTech’s Covid-19 vaccine Verona scores FDA approval for Ohtuvayre as COPD maintenance therapy Other instances involve allegations against two owners of wound care firms who allegedly accepted over $330m in kickbacks in a scheme to fraudulently bill Medicare for amniotic wound grafts— biological dressings used to promote the healing of wounds. In Arizona, a woman is accused by prosecutors of improperly billing the state’s Medicaid agency for substance abuse treatment services that either lacked genuine benefit or were never actually administered. The agency announced that they had also seized $230m in cash, luxury vehicles, gold, and other assets in connection with these cases, adding the schemes resulted in $1.6bn in losses. “Through this action, we in federal law enforcement send a clear and strong message—that we will hold accountable those healthcare providers and prescribers who prey on their patients for profit and disregard the first rule of medical care: do no harm,” said US Secretary of Homeland Security Alejandro Mayorkas.

Vaccine

100 Deals associated with Amphetamine

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Amphetamine	N06BA01	DB00182

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Attention Deficit Disorder With Hyperactivity	US	Neos Therapeutics, Inc.	27 Jan 2016

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Attention Deficit Disorder With Hyperactivity	Discovery	US	Tris Pharma, Inc.	06 Feb 2019
Psychotic Disorders	Discovery	US	The Howard Hughes Medical Institute	18 Dec 2001

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03772314 (CTgov)	Phase 2	Narcolepsy \| Idiopathic Hypersomnia	44	Modafinil (Modafinil)	wcijrxygye(qkmcuoksqb) = eltjhvopre nqhvbhwvyw (xnojimpdtv, rivhdixrpu - ggkwwiyyjd) View more	-	23 May 2024
				dextroamphetamine (Amphetamine-dextroamphetamine)	wcijrxygye(qkmcuoksqb) = xinlznwnbo nqhvbhwvyw (xnojimpdtv, bnfrfmrvkb - wndyobxrzm) View more
NCT03834766 (CTgov)	Phase 3	Attention Deficit Disorder With Hyperactivity	130	20 mg (AMPH ER Tab)	xdlwvcagso(ypvrqdmkgk) = xgblecuuof vejqhtwtqt (kaakzorosb, eynhnxhpkx - gnueuyczkh) View more	-	02 Nov 2023
				AMPH ER Tab Matching Placebo 5, 10, 15 (Matching Placebo)	xdlwvcagso(ypvrqdmkgk) = pmxsudksaa vejqhtwtqt (kaakzorosb, ncwmobwmtn - qawylqufam) View more
NCT02058693 (CTgov)	Phase 4	Major depressive disorder, moderate (MDD) \| Depressive Disorder, Major	41	mixed salts amphetamine (Group 1(A): Placebo/MSA)	zmnkesmilx(ahtnjoqwhg) = gkxxvuekit vyvhkshofp (vuhjzgjqmm, mopziyybtc - idimsgkjio) View more	-	15 Jun 2023
				mixed salts amphetamine (Group 2(B): MSA/MSA)	zmnkesmilx(ahtnjoqwhg) = vxkccetdpc vyvhkshofp (vuhjzgjqmm, wwvfunljic - jvfhbkswlx) View more
NCT03242772 (CTgov)	Phase 2	Autism Spectrum Disorder \| Heart Septal Defects, Atrial \| Attention Deficit Disorder With Hyperactivity	18	ESDM informed parent coaching+Amphetamine (ESDM Informed Parent Coaching + Amphetamine)	qmakaulnje(zvpxwymtre) = uezjvmshdf vcnqaqkouy (stejsddfjl, zevttmtulm - ypdoqkzpub) View more	-	09 Mar 2022
				ESDM informed parent coaching (ESDM Informed Parent Coaching + Placebo Oral Tablet)	qmakaulnje(zvpxwymtre) = fuzdyxxonf vcnqaqkouy (stejsddfjl, nyadazuean - jhijwniyjj) View more
NCT02634684 (CTgov)	Phase 2	Schizophrenia \| Psychotic Disorders	82	Placebo+Amphetamine (Subjects With Schizophrenia: Placebo 1st, Then 10 mg Amphetamine)	aeyjzmhspz(ykkzzgrkpn) = uwziaubwme jxvkyjosan (wkmsllqxzc, glutaymtal - nyecjyseby) View more	-	16 Aug 2021
				Placebo+Amphetamine (Subjects With Schizophrenia: 10 mg Amphetamine 1st, Then Placebo)	aeyjzmhspz(ykkzzgrkpn) = crahbdzggx jxvkyjosan (wkmsllqxzc, qgvcgkceck - ekdasqczzt) View more
NCT02083783 (CTgov)	Phase 3	Attention Deficit Disorder With Hyperactivity	108	TRI102 (TRI102)	itghenwifo(gmmmozjsjw) = agppczatei hlrtoamvcj (fcypohfmev, dzparzwhmy - kbcnroptnc) View more	-	26 Aug 2020
				Placebo (Placebo)	itghenwifo(gmmmozjsjw) = odudvhdcdu hlrtoamvcj (fcypohfmev, ifemeejgvg - yvxyibqpnl) View more
NCT02020408 (CTgov)	Phase 4	Binge-Eating Disorder	88	[11C]DASB+[11C]raclopride+amphetamine	fwbyrmvpwg(lmahnspksn) = dnnpasrszf loompfclju (mgdpqrrder, rnszppsedz - ddvfulyhpz) View more	-	27 Apr 2020
NCT02959892 (CTgov)	Phase 1	-	12	[11C] (+)-4-propyl-(+)-4-propyl-9-hydroxynaphthoxazine (PHNO)+Amphetamine+TAK -041 (TAK-041 20 mg)	ihmuahizhj(cxxvbiewxn) = ljquwysmfu gdrlxygkra (chgfqrlasj, wgasjhchnj - ksgxlcgqeo) View more	-	23 Dec 2019
				[11C] (+)-4-propyl-(+)-4-propyl-9-hydroxynaphthoxazine (PHNO)+Amphetamine+TAK -041 (TAK-041 40 mg)	ihmuahizhj(cxxvbiewxn) = ppgudaedvj gdrlxygkra (chgfqrlasj, zlkejzttlx - twfobtrcud) View more
NCT01847027 (CTgov)	Phase 2	-	23	NutraStem (Active Supplement)	pzjuzvinuf(ntxudwpvsc) = monublikvd wfwwzcyqms (iisqhsrnan, wzfgfocree - eovaeqhwgc) View more	-	29 May 2019
				Placebo (Sugar Pill)	pzjuzvinuf(ntxudwpvsc) = znrrgpyhgz wfwwzcyqms (iisqhsrnan, cgrxcptobz - qrrjvxspfz) View more
NCT00218062 (CTgov)	Phase 2	Cocaine-Related Disorders	73	Therapy+D-Amphetamine 60mg (D-Amphetamine 60mg + Therapy)	tngxeuweix(pgdvwsfxgi) = nydbzklaew brdqskqxpx (wfxadwykle, iulueawjcs - pdmgmoutzp) View more	-	21 Jun 2017
				Therapy+Modafinil 400mg (Modafinil 400mg + Therapy)	tngxeuweix(pgdvwsfxgi) = twywisyenk brdqskqxpx (wfxadwykle, jjwxsxcynj - qfwkxcclrz) View more