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

499

Literatures (Medical) associated with Amphetamine Sulfate

01 May 2024·Heliyon

Effect of propofol and ciprofol on the euphoric reaction in patients with painless gastroscopy: A prospective randomized controlled trial

Article

Author: Gong, Chuhao ; Liu, Zhouliang ; Zhang, Jin ; Li, Teng ; Peng, Peng ; Lu, Yao ; Heng, Lei ; Gao, Kailun ; Wang, Liwei ; Han, Dan ; Wu, Ying

ObjectiveTo explore the effects of propofol and ciprofol on patient euphoric reactions during sedation in patients undergoing gastroscopy and to investigate potential factors that may influence euphoric reactions in patients.MethodsA total of 217 patients were randomly divided into two groups: the propofol group (P group, n = 109) and the ciprofol group (C group, n = 108). The patients in the P group were given 2 mg/kg propofol, and those in the C group were given 0.5 mg/kg ciprofol. The patients were assessed using the Addiction Research Center Inventory-Chinese Version (ARCI-CV) to measure euphoric reactions at three time points: preexamination, 30 min after awakening, and 1 week after examination. Anxiety, depression, and sleep status were evaluated using appropriate scales at admission and 1 week after the examination. The dream rate, sedative effects, vital sign dynamics, and adverse reactions were documented during the sedation process.ResultsAfter 30 min of awakening, the P group and C group showed no statistically significant differences in the mean morphine-benzedrine group (MBG) score (8.84 vs. 9.09, P > 0.05), dream rate (42.2 % vs. 40.7 %, P > 0.05), or MBG score one week after the examination (7.04 vs. 7.05, P > 0.05). The regression analysis revealed that sex, dream status, Alcohol Use Disorders Identification Test (AUDIT) score, and examination time had notable impacts on the MBG-30 min score. No statistically significant differences were observed in sedative effects, anxiety, depression, or sleep status between the two groups (P > 0.05). The incidence of injection pain and severe hypotension was significantly lower in the C group (P < 0.05), and hemodynamics and SpO₂ were more stable during sedation (P < 0.05).ConclusionThere was no significant difference between propofol and ciprofol in terms of euphoria experienced by patients after sedation in patients undergoing gastroscopy. Ciprofol has demonstrated addictive potential similar to that of propofol, warranting careful attention to its addictive potential during clinical application.

01 Mar 2024·Journal of Addiction Medicine

Responses to a “Typical” Morning Dose of Kratom in People Who Use Kratom Regularly: A Direct-Observation Study

Article

Author: Feldman, Jeffrey D. ; Taylor, Richard C. ; Rogers, Jeffrey M. ; Sharma, Abhisheak ; Epstein, David H. ; Raju, Kanumuri Siva Rama ; Smith, Kirsten E. ; McCurdy, Christopher R. ; Kuntz, Michelle A. ; Weiss, Stephanie T. ; Dunn, Kelly E. ; Mukhopadhyay, Sushobhan

IntroductionUse of kratom has outpaced systematic study of its effects, with most studies reliant on retrospective self-report.MethodsWe aimed to assess acute effects following kratom use in adults who use regularly, and quantify alkaloids in the products, urine, and plasma. Between July and November 2022, 10 adults came to our clinic and orally self-administered their typical kratom dose; blinding procedures were not used. Physiological measures included blood pressure, respiratory rate, heart rate, pulse oximetry, temperature, and pupil diameter. Subjective outcomes included Subjective Opioid Withdrawal Scale, Addiction Research Center Inventory, and Drug Effects Questionnaire. Psychomotor performance was also assessed.ResultsParticipants were 6 men and 4 women, mean age 41.2 years. Nine were non-Hispanic White; 1 was biracial. They had used kratom for 6.6 years (SD, 3.8 years) on average (2.0–14.1). Sessions were 190.89 minutes on average (SD, 15.10 minutes). Mean session dose was 5.16 g (median, 4.38 g; range, 1.1–10.9 g) leaf powder. Relative to baseline, physiological changes were minor. However, pupil diameter decreased (right, b = −0.70, P < 0.01; left, b = −0.73, P < 0.01) 40–80 minutes postdose and remained below baseline >160 minutes. Subjective Opioid Withdrawal Scale pre-dosing was mild (5.5 ± 3.3) and decreased postdose (b = [−4.0, −2.9], P < 0.01). Drug Effects Questionnaire “feeling effects” increased to 40/100 (SD, 30.5) within 40 minutes and remained above baseline 80 to 120 minutes (b = 19.0, P = 0.04), peaking at 72.7/100; 6 participants rated euphoria as mild on the Addiction Research Center Inventory Morphine-Benzedrine-scale. Psychomotor performance did not reliably improve or deteriorate postdosing.ConclusionsAmong regular consumers, we found few clinically significant differences pre- and post-kratom dosing. Alkaloidal contents in products were within expected ranges.

01 Jan 2023·Frontiers in psychiatry

Factors associated with euphoria in a large subset of cases using propofol sedation during gastrointestinal endoscopy.

Article

Author: Zhao, Kaixuan ; Wang, Xiaoxiao ; Guo, Xiangyang ; Yang, Ning ; Kang, Ning ; Han, Ying ; Xu, Mao ; Yue, Jingli ; Zhang, Tianhao

BackgroundThe utilization of Propofol, a widely used intravenous sedative or anesthetic, is characterized by its quick onset, predictable control, and fleeting half-life during both general anesthesia and intensive care unit sedation. Recent evidence, however, has highlighted propofol's propensity to induce euphoria, particularly in patients undergoing painless procedures such as gastrointestinal or gastric endoscopy. Given its widespread use in patients undergoing such procedures, this study aims to investigate the clinical evidence and factors that may influence propofol-induced euphoria in these settings.MethodsThe Addiction Research Center Inventory-Chinese Version (ARCI-CV) scale was administered to 360 patients undergoing gastric or gastrointestinal endoscopy using propofol as a sedative. Patient characteristics including past medical history, depression, anxiety, alcohol abuse, and sleep disturbance were recorded through history taking and assessment using various questionnaires prior to the examination. The euphoric and sedative statuses were assessed at 30 min and 1 week post-examination.ResultsThe experimental results of a survey of 360 patients who underwent gastric or gastrointestinal endoscopy using propofol showed that the mean Morphine-Benzedrine Group (MBG) score before the procedure and after 30 min of the procedure was 4.23 and 8.67, respectively. The mean Pentobarbital-Chlorpromazine-Alcohol Group (PCAG) score before the procedure and after 30 min of the procedure was 3.24 and 6.22, respectively. These results showed that both MBG and PCAG scores increased significantly after the procedure. Certain factors, such as dreaming, propofol dose, duration of anesthesia, and etomidate dose, were all correlated with MBG both at 30 min and 1 week after the examination. In addition, etomidate had an effect of decreasing MBG scores and increasing PCAG scores both at 30 min and 1 week after the examination.ConclusionTaken together, propofol may elicit euphoria and potentially contribute to propofol addiction. There are several risk factors for the development of propofol addiction, including dreaming, propofol dose, duration of anesthesia, and etomidate dose. These findings suggest that propofol may have a euphoric effect and may have the potential for drug addiction and abuse.

News (Medical) associated with Amphetamine Sulfate

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

12 Dec 2023

·www.biospace.com

Elite Pharmaceuticals Announces First Product Shipment of Generic Adderall XR(R) to Marketing Partner Prasco, LLC

NORTHVALE, NJ / ACCESSWIRE / December 12, 2023 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP), a specialty pharmaceutical company developing niche generic products, today announced the first shipment of generic Adderall XR® to its distribution and marketing partner Prasco, LLC ("Prasco"). Adderall XR® is an extended-release mixed salt of a single entity Amphetamine product (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate) with strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg capsules (the "Products"). Prasco is, pursuant to the manufacturing and supply agreement dated April 5, 2023 ("Agreement") between the companies, a non-exclusive U.S. distributor of the Products. Prasco will market the Products under Burel Pharmaceutical's label, and Elite will manufacture the Products. Elite's product is co-owned with Mikah Pharma. About Prasco, LLC Prasco is a privately held healthcare company located in Mason, Ohio. Over 50 of the most innovative and trusted pharmaceutical companies have relied on Prasco to bring their products to the US generic marketplace. Prasco provides patients with high-quality products at affordable prices in over 60,000 US pharmacies. For more information, visit the company's website at . About Elite Pharmaceuticals, Inc. Elite Pharmaceuticals, Inc. is a specialty pharmaceutical company that develops, manufactures, and distributes niche generic products. Elite's product lines consist of immediate-release and controlled-release, solid oral dose products, which are marketed under the Elite Laboratories label, as well as pursuant to licenses granted to third-party pharmaceutical marketing and distribution organizations. Elite operates a cGMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ. For more information, visit . This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, those related to the effects, if any, on future results, performance or other expectations that may have some correlation to the subject matter of this press release. Readers are cautioned that such forward-looking statements involve, without limitation, risks, uncertainties and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements. These forward-looking statements may include statements regarding the expected timing of approval, if at all, of products by the FDA, and the actions the FDA may require of Elite in order to obtain such approvals. These forward-looking statements are not guarantees of future action or performance. These risks and other factors are discussed, without limitation, in Elite's filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q, and 8-K. Elite is under no obligation to update or alter its forward-looking statements, whether as a result of new information, future events or otherwise. CONTACT: For Elite Pharmaceuticals, Inc. Dianne Will, Investor Relations, 518-398-6222 Dianne@elitepharma.com SOURCE: Elite Pharmaceuticals, Inc. View the original press release on accesswire.com

License out/in

23 Aug 2023

·www.biospace.com

GRI Bio Enters into Asset Purchase Agreement with Aardvark Therapeutics, Inc. for the Sale of Legacy Asset, ADAIR

Aardvark to acquire global development and commercialization rights to ADAIR and all intellectual property outside of Europe and licensor rights for the EU Aardvark to leverage ADAIR formulation technology for certain follow-on pipeline programs in development GRI to receive modest upfront payment and potential to earn development and commercial milestones up to approximately $80million LA JOLLA, CA, Aug. 23, 2023 (GLOBE NEWSWIRE) -- GRI Bio, Inc. (NASDAQ: GRI) (“GRI Bio” or the “Company”), a biotechnology company advancing an innovative pipeline of Natural Killer T (“NKT”) cell modulators for the treatment of inflammatory, fibrotic and autoimmune diseases, today announced that the Company has entered into an asset purchase agreement pursuant to which Aardvark Therapeutics, Inc. (“Aardvark”) will acquire certain assets and intellectual property of the Company that pertain to ADAIR (Abuse Deterrent Amphetamine Immediate Release). Aardvark intends to utilize the ADAIR formation technology for the development of certain follow-on pipeline programs. ADAIR, a legacy asset from the merger with Vallon Pharmaceuticals, Inc. (“Vallon”), is a proprietary abuse-deterrent formulation of immediate release dextroamphetamine for the treatment of attention deficit hyperactivity disorder (“ADHD”) designed to deter attempts to crush and snort it or take it by other non-oral routes that can produce a greater “high.” Under the terms of the agreement, Aardvark will assume responsibility for and endeavor to develop and commercialize the purchased assets. Exclusive license rights to develop and commercialize ADAIR in Europe and the UK were previously licensed to Medice Arzneimittel Pütter GmbH, a leader in the European ADHD market. GRI Bio will receive a modest up-front payment and the potential to earn milestone payments for achievements in development and commercialization from Aardvark up to approximately $80 million. “This agreement represents a great opportunity for GRI Bio as it allows us to optimize our non-strategic asset that we acquired through our merger with Vallon, while allowing us to maintain our focus on advancing our pipeline of novel assets in development for inflammatory and fibrotic diseases. We believe in the potential of ADAIR and are pleased to have it continue on in its development at Aardvark,” commented Marc Hertz, PhD, Chief Executive Officer of GRI Bio. “There continues to be an unmet need for effective products that address the significant and growing problem of stimulant misuse and abuse. ADAIR has demonstrated abuse deterrent properties, but did not surmount the established threshold in its most recent clinical trial to support pursuing an FDA approval. However, we believe there is a real opportunity to utilize Aardvark’s proprietary ARD-101 technology with its established clinical safety pro provide a new formulation to substantially boost the deterrent effect of ADAIR to ultimately gain regulatory approval,” added Tien Lee, M.D., Chief Executive Officer of Aardvark. As the current lead programs utilizing ARD-101 as an orally administered therapeutic agent for Prader-Willi Syndrome will be continuing at Aardvark unabated, Aardvark is considering establishing a separate entity to continue development of ADAIR with ARD-101 to address the urgent need for effective products that will deter stimulant abuse. About Aardvark Therapeutics, Inc. Aardvark Therapeutics is a clinical stage biopharmaceutical company focused on developing novel small molecule therapeutics to activate innate homeostatic pathways for the treatment of metabolic diseases, inflammation, and other indications. Founded in 2017, the company has now advanced ARD-101 to Phase II clinical trials. Aardvark has multiple other programs in its pipeline. For more information visit . About GRI Bio, Inc. GRI Bio is a clinical-stage biopharmaceutical company focused on fundamentally changing the way inflammatory, fibrotic and autoimmune diseases are treated. GRI Bio’s therapies are designed to target the activity of NKT cells, which are key regulators earlier in the inflammatory cascade, to interrupt disease progression and restore the immune system to homeostasis. NKT cells are innate-like T cells that share properties of both NK and T cells and are a functional link between the innate and adaptive immune responses. Type I invariant NKT (“iNKT”) cells play a critical role in propagating the injury, inflammatory response, and fibrosis observed in inflammatory and fibrotic indications. GRI Bio’s lead program, GRI-0621, is an inhibitor of iNKT cell activity and is being developed as a novel oral therapeutic for the treatment of idiopathic pulmonary fibrosis, a serious disease with significant unmet need. The Company is also developing a pipeline of novel type 2 NKT agonists for the treatment of systemic lupus erythematosus. Additionally, with a library of over 500 proprietary compounds, GRI Bio has the ability to fuel a growing pipeline. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions. These forward-looking statements are based on the Company’s current beliefs and expectations. Forward-looking statements include, but are not limited to, statements regarding: the Company’s expectations with respect to development and commercialization of the Company’s or Aardvark’s product candidates, the initiation or completion of clinical trials, the potential benefits and impact of the Company’s or Aardvark’s product candidates, any estimate or implication as to potential market size or potential revenue, and any reference to potential milestone achievements or related contingent payments, which may or may not be achieved, paid or received in the future. Actual results may differ from the forward-looking statements expressed by the Company or Aardvark in this press release and consequently, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including, without limitation: (1) the inability to maintain the listing of the Company’s common stock on Nasdaq; (2) changes in applicable laws or regulations; (3) the inability of the Company to raise financing in the future; (4) the success, cost and timing of the Company’s or Aardvark’s product development activities; (5) the inability of the Company or Aardvark to obtain and maintain regulatory clearance or approval for their respective products, and any related restrictions and limitations of any cleared or approved product; (6) the inability of the Company to identify, in-license or acquire additional technology; (7) the inability of the Company or Aardvark to compete with other companies currently marketing or engaged in the development of products and services that the Company or Aardvark are currently developing; (8) the size and growth potential of the markets for the Company’s or Aardvark’s products and services, and their respective ability to serve those markets, either alone or in partnership with others; (9) the failure to achieve any milestones or receive any milestone payments under the asset purchase agreement; (10) inaccuracy in the Company’s or Aardvark’s estimates regarding expenses, future revenue, capital requirements and needs for and the ability to obtain additional financing; (11) the Company’s or Aardvark’s ability to protect and enforce its intellectual property portfolio, including any newly issued patents; and (12) other risks and uncertainties indicated from time to time in the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including the risks and uncertainties described in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K filed with the SEC on February 24, 2023 and subsequently filed reports. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law. Investor Contact: JTC Team, LLC Jenene Thomas (833) 475-8247 GRI@jtcir.com

License out/inPhase 2Cell Therapy

100 Deals associated with Amphetamine Sulfate

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KEGG	Wiki	ATC	Drug Bank
-	Amphetamine Sulfate	N06BA01	-

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Attention Deficit Disorder With Hyperactivity	Discovery	US	Azurity Pharmaceuticals, Inc.	30 Jan 2019

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed Manual	Not Applicable	-	-	Amphetamines	kgcygkkzbe(tgjkehqtkj) = high doses of amphetamines (>30 mg dextroamphetamine equivalents) were associated with 5.28-fold increased odds of psychosis or mania. ajciyhjmhp (vygxqpkccl )	Negative	01 Oct 2024
				Control
NCT03659929 (CTgov)	Phase 3	Attention Deficit Disorder With Hyperactivity	320	placebo (Placebo)	meajnbteum(wydwjmvsrn) = ottfacuuow yjvgmdjrno (uoxsazgqmv, tylxmgnmsv - epbvzipeyx) View more	-	03 Sep 2024
				Amphetamine Sulfate (Amphetamine Sulfate (20 mg/Day))	meajnbteum(wydwjmvsrn) = igadwqbotf yjvgmdjrno (uoxsazgqmv, zbqcnwzgjr - rnfmzqacle) View more
NCT00715520 (CTgov)	Not Applicable	Stroke	33	Placebo+Methylphenidate+Amphetamine Sulfate+Carbidopa-Levodopa (Aim 1)	sblxqfzuqu(icqjrhyviq) = eaxkrobchw dsvcvklxtr (odbbffozmi, tshrsoubmc - yeiyunwjbj) View more	-	16 Oct 2017
				Transcranial Magnetic Stimulation (TMS) (Aim 2)	ddlhaijspa(jkecsufynw) = ospuxvrobp iitryaczjx (jomcsxmybq, yqzjqnblzx - gcqsxmuiwa) View more
NCT01986062 (CTgov)	Phase 4	Attention Deficit Disorder With Hyperactivity	97	AR11 (Amphetamine Sulfate) (AR11 (Amphetamine Sulfate))	xlintvfrzg(cekvkqammv) = fnsxnpwlfg vexjqxvrdu (mlffthecev, zanhglanqz - svhiztdsks) View more	-	19 Apr 2016
				Placebo (Placebo)	xlintvfrzg(cekvkqammv) = qehxhsuxsv vexjqxvrdu (mlffthecev, zoiqoivsvs - kulsonlorn) View more

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