Dextroamphetamine

How do stimulants actually work to reduce ADHD symptoms?

Retrieved on: 
Friday, October 27, 2023

Stimulants are first-line drugs for children and adults diagnosed with attention-deficit hyperactivity disorder (ADHD). But how do they actually work?First, let’s look at the brainMedical imaging indicates people with ADHD may have slight differences in their brain’s structure, the way their brain regions work together to perform tasks, and how their brain’s chemical messengers, called neurotransmitters, pass on information.

Key Points: 


Stimulants are first-line drugs for children and adults diagnosed with attention-deficit hyperactivity disorder (ADHD). But how do they actually work?

First, let’s look at the brain

  • Medical imaging indicates people with ADHD may have slight differences in their brain’s structure, the way their brain regions work together to perform tasks, and how their brain’s chemical messengers, called neurotransmitters, pass on information.
  • These brain differences are associated with the symptoms of ADHD, including inattention, impulse control and problems with memory.

What stimulants are prescribed in Australia?

  • The three main stimulants prescribed for ADHD in Australia are dexamfetamine, methylphenidate (sold under the brand names Ritalin and Concerta) and lisdexamfetamine (sold as Vyvanse).
  • Dexamfetamine and methylphenidate have been around since the 1930s and 1940s respectively.

So how do they work for ADHD?

  • Stimulants increase the amount of dopamine and noradrenaline in the tiny gaps between neurons, known as synapses.
  • They do this by predominantly blocking a transporter that then prevents their re-uptake back into the neuron that released them.
  • Amphetamines also increase the amount of dopamine the neuron releases into the synapse (the tiny gaps between neurons).

What effect do they have on ADHD symptoms?


We still don’t fully understand the underlying brain mechanisms that change behaviour in people with ADHD. But research shows stimulants that modulate noradrenaline and dopamine can improve brain processes such as:
They can also improve general behaviour, such as self-control, not talking over the top of others, and concentration. These behaviours are important for social interactions. Stimulants reduce ADHD symptoms in about 70% to 80% of children and adults who take them. Some people will notice their symptoms improve right away. Other times, these improvements will be more noticeable to parents, carers, teachers, colleagues and partners.

Not everyone gets the same dose


The optimal stimulant dose varies between individuals, with multiple dosage options available. This enables a “start low, go slow” approach, where the stimulant can be gradually increased to the most effective dose for the individual.

  • Dexamfetamine and methylphenidate are available in immediate-release preparations.
  • As these have short half-lives (meaning they act quickly and wear off rapidly), they are often taken multiple times a day – usually in the morning, lunch and afternoon.
  • Methylphenidate is also available in long-acting tablets (Concerta) and capsules (Ritalin LA).

What are the side effects?


The most common side effects are sleep problems and decreased appetite. A recent study showed children and young people taking methylphenidate for ADHD were around 2.6 times more likely to have sleep problems and 15 times more likely to have a decreased appetite than those not taking methylphenidate. Headache and abdominal pain are also relatively common.

Can someone without ADHD take a stimulant to improve productivity?

  • As stimulants increase dopamine, they can cause euphoria and a heightened sense of wellbeing.
  • A common myth about stimulant medicines is they can improve the concentration and productivity of people without ADHD.
  • At each of the sessions, participants were given either a placebo or a stimulant before completing the task.
  • Read more:
    ADHD medications have doubled in the last decade – but other treatments can help too


Mary Bushell does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.

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

Retrieved on: 
Wednesday, August 23, 2023

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.

Key Points: 
  • Aardvark intends to utilize the ADAIR formation technology for the development of certain follow-on pipeline programs.
  • 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.
  • 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.

Cingulate Inc. Reports Second Quarter 2023 Financial Results and Provides Clinical and Business Update

Retrieved on: 
Monday, August 14, 2023

KANSAS CITY, Kan., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING) (Cingulate or the Company), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today provided financial results for the quarter ended June 30, 2023, as well as a clinical and business update. Among other highlights, the Company announced a $1 million dollar investment from Werth Family Investment Associates LLC (WFIA), top-line results following the completion of a Phase 3 Adult Efficacy and Safety Trial of CTx-1301, and the initiation of the CTx-1301 Phase 3 pediatric and adolescent studies.

Key Points: 
  • CTx-1301: Cingulate advanced its clinical program for CTx-1301 on the streamlined approval pathway under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.
  • As part of that effort:
    Cingulate completed a Phase 3 adult dose-optimization study in June 2023 and announced top-line results in July 2023.
  • Assuming positive clinical results from the upcoming Phase 3 trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 in the second half of 2024 under the Section 505(b)(2) pathway.
  • Cingulate expects its cash and cash equivalents will enable the Company to fund its research and development and operating expenditures into September 2023.

Cingulate Inc. Reports First Quarter 2023 Financial Results and Provides Clinical and Business Update

Retrieved on: 
Wednesday, May 10, 2023

KANSAS CITY, Kan., May 10, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today provided financial results for the three months ended March 31, 2023, as well as a clinical and business update. Among other highlights, the Company announced it has obtained an additional $3 million of debt financing, successfully completed the transfer of its proprietary PTR™ manufacturing processes to Societal CDMO, Inc. (Societal) and entered into a joint commercialization agreement with Indegene to provide commercial support for CTx-1301 upon approval from the U.S. Food and Drug Administration (FDA).

Key Points: 
  • CTx-1301: Cingulate advanced its clinical program for CTx-1301 on the streamlined approval pathway under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.
  • Assuming positive clinical results from the Phase 3 trials, Cingulate plans to submit the NDA for CTx-1301 in mid-2024 under the Section 505(b)(2) pathway.
  • Cash Position: As of March 31, 2023, Cingulate had $1.7 million in cash and cash equivalents.
  • This decrease in manufacturing expense was slightly offset by an increase in clinical and regulatory costs as we initiated a Phase 3 clinical trial for CTx-1301 in the first quarter of 2023.

Cingulate Inc. Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Clinical and Business Update

Retrieved on: 
Friday, March 10, 2023

KANSAS CITY, Kan., March 10, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced its financial results for the three and 12 months ended December 31, 2022, and provided a clinical and business update. Highlights include multiple clinical updates on CTx-1301, the Company’s lead candidate being investigated as a true, once-daily treatment for attention deficit/hyperactivity disorder (ADHD).

Key Points: 
  • Highlights include multiple clinical updates on CTx-1301, the Company’s lead candidate being investigated as a true, once-daily treatment for attention deficit/hyperactivity disorder (ADHD).
  • Dr. Childress has conducted over 180 clinical studies and is considered a preeminent global ADHD expert.
  • CTx-1301: Cingulate advanced its clinical program for CTx-1301 on the streamlined approval pathway under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.
  • In addition, the Company’s manufacturing costs increased in 2022 relating to the production of clinical supply for Phase 3 trials of CTx-1301.

Glenmark and Cediprof Announce Exclusive Distribution Agreement in the United States for US FDA Approved Mixed Amphetamines Immediate-Release Tablets

Retrieved on: 
Thursday, March 9, 2023

MUMBAI, India and MAHWAH, N.J. and CAGUAS, Puerto Rico, March 9, 2023 /PRNewswire/ -- Glenmark Pharmaceuticals Inc., USA and Cediprof, Inc. (a part of the Neolpharma Pharmaceutical Group family of companies) have entered into an exclusive supply and distribution agreement for Cediprof's FDA-approved 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, the generic version of Adderall®1 Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, of Teva Women's Health, Inc. Glenmark expects to commence distribution of the product in the U.S. during the second half of 2023. This product has long been on FDA's shortage list.

Key Points: 
  • Commenting on the launch, Brendan O'Grady, Chief Executive Officer – Glenmark Global Formulations Business 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 alleviate the shortage this country is facing by partnering with Cediprof and Neol."
  • According to IQVIA™ sales data for the 12-month period ending January 2023, the Adderall® Tablets, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg market2 achieved annual sales of approximately $389.8 million*.
  • Glenmark's current portfolio consists of 180 products authorized for distribution in the U.S. marketplace and 48 ANDA's pending approval with the U.S. FDA.

Global Attention Deficit Hyperactivity Disorder Market Report 2022: Increasing Recognition of Behavioral Therapy Benefits Boosts Sector - ResearchAndMarkets.com

Retrieved on: 
Friday, January 6, 2023

Based on drug type, the attention deficit hyperactivity disorder market is categorized into stimulants and non-stimulants.

Key Points: 
  • Based on drug type, the attention deficit hyperactivity disorder market is categorized into stimulants and non-stimulants.
  • The stimulants segment procured the highest revenue share in the attention deficit hyperactivity disorder market in 2021.
  • The retail pharmacy segment recorded the largest revenue share in the attention deficit hyperactivity disorder market in 2021.
  • On the basis of region, the attention deficit hyperactivity disorder market is analyzed across North America, Europe, Asia Pacific, and LAMEA.

Cingulate Inc. Reports Third Quarter 2022 Financial Results and Provides Clinical and Business Update

Retrieved on: 
Monday, November 14, 2022

KANSAS CITY, Kan., Nov. 14, 2022 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced its financial results for the quarter ended September 30, 2022 and provided a clinical and business update. Highlights include a newly executed Master Services Agreement (MSA) and multiple clinical program updates on its lead Attention Deficit / Hyperactivity Disorder (ADHD) candidate, CTx-1301 (dexmethylphenidate), as well as anxiety asset CTx-2103 (buspirone HCl).

Key Points: 
  • Societal CDMO will dedicate a specific manufacturing suite within its Gainesville, GA facility and outfit it with proprietary equipment owned by Cingulate.
  • CTx-1301: Cingulate advanced its clinical program for CTx-1301 on the expedited approval pathway under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.
  • CTx-2103: Cingulate is constructing a clinical program for CTx-2103 toward an expedited approval pathway under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.
  • In addition, manufacturing of the Phase 3 clinical supply for the fixed-dose study began in the first quarter of 2022 with continued activity through the third quarter of 2022.

Cingulate Inc. Reports First Quarter 2022 Results and Provides Clinical and Business Update

Retrieved on: 
Thursday, May 12, 2022

The Company initiated a human formulation study for CTx-2103 in May 2022 and haved dosed the first subject.

Key Points: 
  • The Company initiated a human formulation study for CTx-2103 in May 2022 and haved dosed the first subject.
  • Results from the study are expected in July 2022, and the site for the study is BDD Pharma, Glasgow, Scotland, UK.
  • In addition, manufacturing the Phase 3 clinical supply for this study began in the first quarter of 2022.
  • The Company has also incurred costs in the first quarter of 2022 relating to a human formulation study for CTx-2103.

Vallon Pharmaceuticals Reports Additional Pharmacokinetic and Pharmacodynamic Data from SEAL Study of ADAIR

Retrieved on: 
Thursday, May 12, 2022

The SEAL study enrolled 55 subjects, of whom 53 completed the study and 52 were included in the final analysis.

Key Points: 
  • The SEAL study enrolled 55 subjects, of whom 53 completed the study and 52 were included in the final analysis.
  • The study involved a four-way crossover design to evaluate professionally manipulated, intranasal ADAIR 30 mg, crushed intranasal dextroamphetamine, ADAIR 30 mg taken orally, and placebo.
  • Vallon has completed its initial analysis of the full data set and has received final tables, figures, and listings for the study.
  • The overall safety and tolerability profile of ADAIR in the SEAL study was consistent with the well-established profile of dextroamphetamine.