Methylphenidate

Draft revised consolidated 3-year work plan for the Methodology Working Party (MWP)

Retrieved on: 
Wednesday, February 14, 2024

Industry level .................................................................................................. 13

Key Points: 
    • Industry level .................................................................................................. 13

      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      1.

    • A reflection paper
      (RP) on the clinical pharmacology package for oligonucleotides is a prioritised activity in the MWP work

      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      plan, and it is envisaged that something similar may be needed for other emerging treatment
      modalities (e.g., peptides).

    • Guideline work led by other working parties
      ?

      Revision of the guideline on the requirements for clinical documentation for orally inhaled
      products (CPMP/EWP/4151/00 Rev.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      The planned concept papers (CPs) will formulate problem statements for potential workshops and
      subsequent guidance documents will be informed and enriched by the outcome of discussions of
      workshops to be held in 2024.

    • Guideline work led by other working parties and committees
      ?

      Revision of Guidance on the investigation of medicinal products in the term and preterm
      neonate (EMEA/536810/2008).

    • There is a need for
      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      new guidance in these areas to ensure these novel approaches meet the required evidentiary
      standards and facilitate their evaluation.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      ?

      Revision of Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98/Rev.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      ?

      Provide appropriate support to the EU network for generic and hybrid medicines including
      product-specific requirements.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      2.3.

    • ?

      Cross disciplinary work with Quality Working Party and other stakeholders on physiologically
      based biopharmaceutics modelling (PBBM).

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      ?

      In order to support adequate evaluation of all methodology MWP will aim to facilitate an
      increase in presence and visibility in relevant committees of methodological expertise from
      across the EU network such as CHMP, PRAC, PDCO, CMD(h), ETF and CAT.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      ?

      Product Specific Bioequivalence Guidelines (PSBGLs) (multiple) in liaison with CMD(h): for
      2024, azacitidine, budesonide (LALA GIT), trametinib, dabrafenib, paliperidone palmitate (3M
      depot) and melatonin have been prioritised as the next in series for drafting.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      4.2.

    • ?

      Cross disciplinary work with Quality Working Party and other stakeholders on PBBM model
      assessment.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      ?

      To deliver an improved access to raw data (e.g.

    • ?

      Propose regulatory research priorities for funders in across the activities of Methodology
      Working Party, including in the big data area.

    • ?

      Establish key communication points in national competent authorities and build a resource of
      key messages and communication materials on regulation and methodology.

    • The timing of workshops may need to be arranged according to the

      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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      specific needs of the guidance ? either before the guidance is finalised to gather views and
      expertise; or once it is finalised for training purposes.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

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A brief history of drug-fuelled combatants

Retrieved on: 
Tuesday, January 2, 2024

I don’t know whether he thought that it might reduce pain or improve performance, but the idea of taking drugs before “going into battle” goes back to the beginning of recorded history.

Key Points: 
  • I don’t know whether he thought that it might reduce pain or improve performance, but the idea of taking drugs before “going into battle” goes back to the beginning of recorded history.
  • Indeed, we find frequent mentions of mead drinking by the warriors in Edinburgh in the seventh-century epic poem The Goddodin.
  • These ancient warriors probably used alcohol to reduce anxiety and blunt the horrors they would face on the battlefield.
  • Pervitin (methamphetamine) was given almost freely to all arms of the German war machine.
  • The frontline Nazis called them Panzerschokolade (tank chocolate), due to the feelings of incredible strength and invincibility that the pills gave them.

Behavioural effects


The types of drugs taken by warriors can be lumped into three broad categories: depressants, hallucinogens and stimulants. Alcohol is a depressant that calms the nerves by reducing brain activity. Psychedelic mushrooms such as Amanita muscaria contain a variety of psychoactive substances. Hyoscyamus niger also has a variety of active compounds that cause hallucinations and, importantly, aggressive and combative behaviour.

  • The word “groggy” meaning dazed and unsteady came from British navy sailors exhibiting this behaviour after their daily ration of rum and water (grog).
  • The stimulants, but especially methamphetamine, would also lead to significant weight loss even after only a few days of use.
  • Long-term use, as we saw with the Nazis, would probably lead to emaciated soldiers.

Smart drugs

  • We have seen that soldiers take drugs before battles to calm nerves, deal with the horrors, reduce pain, tolerate lack of food and sleep and improve alertness.
  • The stimulants include drugs such as amphetamine salt mixtures, methylphenidate and modafinil, while nootropics include piracetam, caffeine, cobalamin (vitamin B12), guarana, pyridoxine (vitamin B6) and vinpocetine.
  • The integration of humans, technology and machines is thought to be the future of warfare and drugs that facilitate this are undoubtedly being researched by the military.

Post-traumatic stress disorder

  • There is a long history of soldiers taking alcohol and other drugs to deal with the horrors of what they have seen, or the disappointment of life after leaving the army.
  • These veterans are taking MDMA and psilocybin on doctors’ orders as part of their treatment for PTSD.
  • Ketamine is useful for treating depression and LSD is also being tested for various psychiatric disorders.


Colin Davidson has previously received funding from the US National Institute on Drug Abuse (NIDA). He is a consultant with the Defence Science and Technology Laboratory (UK).

ADHD drug shortages are affecting patients in the UK – here's why they're happening

Retrieved on: 
Tuesday, November 7, 2023

Millions of people in the UK who take drugs for attention deficit hyperactivity disorder (ADHD) are facing difficulties getting their prescriptions filled due to shortages.

Key Points: 
  • Millions of people in the UK who take drugs for attention deficit hyperactivity disorder (ADHD) are facing difficulties getting their prescriptions filled due to shortages.
  • These shortages are currently affecting four of the five types of medicine licensed in the UK to treat ADHD.

What’s causing these shortages?

  • Not only that, but a growing number of adults are now being diagnosed with ADHD – meaning that even more people are seeking access to ADHD drugs.
  • For example, between April and June 2023 about 202,000 new people in England received a prescription for these drugs.
  • Multiple factors have been linked to this shortage – including a manufacturing delays, increased demand, restrictions on what drugs pharmacists can supply and quota issues.
  • In the US, the quotas may be too low, manufacturing may not be optimised, or the right people may not be receiving the products, causing shortages.
  • There are now reports that people are also having difficulty filling other ADHD medications, such as Concerta and Focalin.

Managing shortages

  • They can help them concentrate better, be less impulsive, feel calmer and learn and practise new skills.
  • Some patients report rationing their prescriptions to make them last longer or have taken to stockpiling them.
  • Patients who have been affected will have been notified by their normal pharmacy of any supply issues.
  • Changing medications or prescribed dosages can sometimes be a strategy to manage shortages so that patients can continue treatment.
  • It’s also unclear if the shortages will be resolved by the end of 2023 as predicted.


The authors do not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and have disclosed no relevant affiliations beyond their academic appointment.

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.

GREENSHIELD ADMINISTRATION RELEASES 2023 DRUG TRENDS REPORT: THE INTRODUCTION OF NEW THERAPIES INCREASE UTILIZATION RATES

Retrieved on: 
Thursday, October 19, 2023

Today, GreenShield introduces its 2023 GreenShield Administration Drug Trends Report , revealing key insights surrounding three main therapeutic categories that go beyond Ozempic.

Key Points: 
  • Today, GreenShield introduces its 2023 GreenShield Administration Drug Trends Report , revealing key insights surrounding three main therapeutic categories that go beyond Ozempic.
  • "In the ever-changing world of healthcare, GreenShield's 2023 Administration Drug Trends Report reveals a compelling narrative, with an overall rise in utilization rates - driven by new therapies and changes in how plan members approach their health," said Mark Rolnick, Executive Vice President, Head of GreenShield Administration.
  • This year's report provides data based on +32 million claims from over two million drug claimants processed by GreenShield Administration this year.
  • Beyond its annual Drug Trends report, GreenShield Administration unlocks better health for all through integrated health and benefits solutions for more than 6 million Canadians from coast-to-coast.

GREENSHIELD ADMINISTRATION RELEASES 2023 DRUG TRENDS REPORT: THE INTRODUCTION OF NEW THERAPIES INCREASE UTILIZATION RATES

Retrieved on: 
Thursday, October 19, 2023

Today, GreenShield introduces its 2023 GreenShield Administration Drug Trends Report , revealing key insights surrounding three main therapeutic categories that go beyond Ozempic.

Key Points: 
  • Today, GreenShield introduces its 2023 GreenShield Administration Drug Trends Report , revealing key insights surrounding three main therapeutic categories that go beyond Ozempic.
  • "In the ever-changing world of healthcare, GreenShield's 2023 Administration Drug Trends Report reveals a compelling narrative, with an overall rise in utilization rates - driven by new therapies and changes in how plan members approach their health," said Mark Rolnick, Executive Vice President, Head of GreenShield Administration.
  • This year's report provides data based on +32 million claims from over two million drug claimants processed by GreenShield Administration this year.
  • Beyond its annual Drug Trends report, GreenShield Administration unlocks better health for all through integrated health and benefits solutions for more than 6 million Canadians from coast-to-coast.

Tris Pharma Secures First ex-US Authorizations for Quillivant ER Oral Suspension and Quillivant ER Chewable Tablet for the Treatment of Attention Deficit Hyperactivity Disorder

Retrieved on: 
Monday, September 25, 2023

Quillivant ER will be available as both an oral suspension and chewable tablet (known in the United States as Quillivant XR® and QuilliChew ER®, respectively).

Key Points: 
  • Quillivant ER will be available as both an oral suspension and chewable tablet (known in the United States as Quillivant XR® and QuilliChew ER®, respectively).
  • Quillivant ER is the first once-daily, long-acting, chewable and oral suspension formulations of methylphenidate to be approved for the treatment of ADHD in Canada.
  • Tris will manufacture Quillivant ER in the United States and export to KYE Pharmaceuticals for Canadian patients.
  • Quillivant ER has demonstrated onset of action as soon as 45 minutes through 12 hours post-dose, providing consistent, continuous delivery throughout the day.

Zevra Therapeutics Presents Full Data Set on the Cardiovascular Safety and Pharmacokinetics of SDX, the sole API in KP1077, in Healthy Volunteers at Psych Congress 2023

Retrieved on: 
Sunday, September 10, 2023

In addition, both doses of SDX were generally better tolerated compared to Ritalin and fewer subjects experienced cardiovascular adverse events after SDX compared to Ritalin.

Key Points: 
  • In addition, both doses of SDX were generally better tolerated compared to Ritalin and fewer subjects experienced cardiovascular adverse events after SDX compared to Ritalin.
  • Lastly, vital signs after a single oral dose of 200 mg SDX (the highest dose tested) were comparable to Ritalin IR 80 mg and Ritalin LA 80 mg.
  • The results demonstrate a robust safety profile for SDX, positioning it as a promising option for treating sleep disorders characterized by excessive daytime sleepiness.
  • Details of Zevra’s poster presentation are as follows:
    Sr. Vice President of Clinical Development, Zevra Therapeutics

 Amneal Receives U.S. FDA Approval for Lisdexamfetamine Dimesylate

Retrieved on: 
Wednesday, September 6, 2023

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (“FDA”) for lisdexamfetamine dimesylate capsules, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.

Key Points: 
  • Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (“FDA”) for lisdexamfetamine dimesylate capsules, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg.
    Lisdexamfetamine dimesylate capsules is a generic version of Vyvanse®.
  • This ADHD product is currently on the U.S. FDA shortage product list, and Amneal has already begun supplying product to the market.
  • Lisdexamfetamine dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and above and for adults with moderate to severe Binge Eating Disorder.
  • According to IQVIA®, U.S. annual sales for lisdexamfetamine dimesylate for the 12 months ended June 2023 were $5.3 billion.

Hi-Tech Pharmaceuticals Launches Adderex® XR- Launches the Strongest Focus Aid Ever Developed that Supports Increased Concentration, Focus & Productivity

Retrieved on: 
Monday, August 7, 2023

Developed after 20 years of Research and Development by Hi-Tech Adderex® XR utilizes several Hi-Tech proprietary Phenylethylamine compounds –– which are the strongest stimulants and focusing aids available without a prescription!

Key Points: 
  • Developed after 20 years of Research and Development by Hi-Tech Adderex® XR utilizes several Hi-Tech proprietary Phenylethylamine compounds –– which are the strongest stimulants and focusing aids available without a prescription!
  • Normal amounts of PEA produced in the body support healthy energy levels as well as attention and focus, well-being, happiness, and cognitive function.
  • * Adderex® XR | Strongest Focusing Aid without a Prescription — Hi-Tech Pharmaceuticals (hitechpharma.com)
    PEA is a trace amine whose molecular mechanism of action differs from biogenic amines, such as serotonin or dopamine.
  • "Adderex® XR is a next-generation focusing aid and will fill the gap left by other manufacturers lack of production of focusing agents.