Dexmethylphenidate

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

Retrieved on: 
Tuesday, November 7, 2023
People, Patient, Drug Enforcement Administration, Medicines and Healthcare products Regulatory Agency, Time, Medication, Government, Plasma protein binding, Workplace, Drug, NHS, Dexmethylphenidate, Prescription, Medicine, Pharmacy, Methylphenidate, Pharmacist, Attention deficit hyperactivity disorder, Ground substance, Adderall, Mental health, ADHD, Dietary supplement, Nursing, Agriculture, Generic drug, Pharmaceutical industry

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.

Societal CDMO Signs Three-Year Manufacturing and Supply Agreement With InfectoPharm for Ritalin LA® in Europe

Retrieved on: 
Thursday, May 5, 2022
U.S. Securities and Exchange Commission, Drug discovery, IND, Methylphenidate, NASDAQ, GLOBE, Company, Securities Exchange Act of 1934, Securities Act of 1933, Physician, Time, ADHD, DEA, Patient, Science, Security (finance), Dexmethylphenidate, Drug Quality and Security Act, Society, CDMO, NASD, Phrase, Excipient, Attention deficit hyperactivity disorder, Technology, SAN, Generic drug, Fine chemical, Novartis

SAN DIEGO, and GAINESVILLE, Ga., May 05, 2022 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (Societal CDMO or Societal; NASD: SCTL ), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has entered into a three-year manufacturing and supply agreement with InfectoPharm for Ritalin LA capsules (methylphenidate hydrochloride extended-release capsules) in Europe.

Key Points: 
  • SAN DIEGO, and GAINESVILLE, Ga., May 05, 2022 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (Societal CDMO or Societal; NASD: SCTL ), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has entered into a three-year manufacturing and supply agreement with InfectoPharm for Ritalin LA capsules (methylphenidate hydrochloride extended-release capsules) in Europe.
  • The new agreement, which is effective immediately and runs through April 2025, establishes Societal as the exclusive supplier of Ritalin LA capsules for the European market through 2023.
  • Novartis recently divested European rights to Ritalin LA capsules to InfectoPharm and this newly signed agreement serves to maintain Societal s role as the exclusive supplier of Ritalin LA capsules in Europe.
  • Societals exclusive Manufacturing and Supply Agreement with Novartis for Ritalin LA and Focalin XR capsules for the remainder of the world remains unchanged and continues through 2023.

Ark Biopharmaceutical Enters Into Exclusive License Agreement for Novel ADHD Treatment Azstarys® in Greater China, With Affiliate of Gurnet Point Capital

Retrieved on: 
Wednesday, December 29, 2021
Attention, Degenerative disease, Diagnosis, Gastrointestinal tract, FDA, Caregiver, Attention deficit hyperactivity disorder, SDX, GLOBE, GPC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Partnership, Ageing, CEO, ADHD, Patient, Drug development, Attention deficit hyperactivity disorder predominantly inattentive, Dexmethylphenidate, Thought, Industry, Pharmaceutical industry, Fine chemical, Corium

SHANGHAI, China, Dec. 28, 2021 (GLOBE NEWSWIRE) -- Shanghai Ark Biopharmaceutical Co., Ltd. (“ArkBio”), an innovative biopharmaceutical company with a depth of expertise in pediatric drug development, today announced that Ark Biopharmaceutical Limited, a wholly-owned subsidiary of ArkBio, entered into an exclusive license agreement with Commave Therapeutics, SA (Commave), an affiliate of Gurnet Point Capital (GPC), a private investment firm focused on the life sciences and medical technology sectors. The license agreement provides for exclusive rights to develop, manufacture, and commercialize the first-in-class once-daily attention deficit hyperactivity disorder (ADHD) treatment AZSTARYS® (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) in Greater China, including mainland China, Hong Kong, Macau, and Taiwan.

Key Points: 
  • The license agreement provides for exclusive rights to develop, manufacture, and commercialize the first-in-class once-daily attention deficit hyperactivity disorder (ADHD) treatment AZSTARYS (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) in Greater China, including mainland China, Hong Kong, Macau, and Taiwan.
  • Corium, Inc., a wholly-owned portfolio company of GPC, is leading the U.S. commercialization efforts and launched AZSTARYS in the U.S. in July 2021.
  • We are pleased to announce our partnership with GPC to bring a transformative next-generation ADHD treatment to patients and their families in China.
  • There are estimated over 20 million ADHD patients in China and the diagnosis and treatment rates are rapidly growing.

Corium Launches Innovative ADHD Treatment AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate) in the U.S. for Patients Age 6 Years and Older

Retrieved on: 
Wednesday, July 21, 2021
Psychoactive drugs, Stimulants, Methylphenidate, Amphetamine, Nootropics, Norepinephrine-dopamine reuptake inhibitors, Attention deficit hyperactivity disorder, Pemoline, Dexmethylphenidate, Attention deficit, Attention deficit hyperactivity disorder management, Attention deficit hyperactivity disorder controversies

Corium, a wholly-owned portfolio company of Gurnet Point Capital (GPC), will lead the U.S. commercialization of AZSTARYS.

Key Points: 
  • Corium, a wholly-owned portfolio company of Gurnet Point Capital (GPC), will lead the U.S. commercialization of AZSTARYS.
  • Corium will offer programs to support patients, providers, and health systems through CoriumCaresTM.
  • AZSTARYS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older.
  • Do not take AZSTARYS if you or your child are:
    allergic to serdexmethylphenidate, methylphenidate, or any of the ingredients in AZSTARYS.

KemPharm Executives to Participate in Panel Discussions During Upcoming June 2021 Conferences

Retrieved on: 
Thursday, June 3, 2021
Psychoactive drugs, Stimulants, Nootropics, Euphoriants, Methylphenidate, Amphetamine, Serdexmethylphenidate, Attention deficit hyperactivity disorder, Idiopathic hypersomnia, Drug, Benzhydrocodone, Dexmethylphenidate

KemPharms prodrug product candidate pipeline is focused on the high need areas of attention deficit hyperactivity disorder, or ADHD, stimulant use disorder (SUD) and CNS rare diseases, including idiopathic hypersomnia (IH).

Key Points: 
  • KemPharms prodrug product candidate pipeline is focused on the high need areas of attention deficit hyperactivity disorder, or ADHD, stimulant use disorder (SUD) and CNS rare diseases, including idiopathic hypersomnia (IH).
  • KemPharms lead clinical development candidate for the treatment of SUD, KP879, is based on its prodrug of d-methylphenidate, known as serdexmethylphenidate (SDX).
  • In addition, KemPharm has received FDA approval for AZSTARYSTM, a new once-daily treatment for ADHD in patents age six years and older, and for APADAZ, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen.
  • For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com or connect with us on Twitter , LinkedIn , Facebook and YouTube .

KemPharm Announces Serdexmethylphenidate (SDX) Has Been Classified as a Schedule IV Controlled Substance by the DEA

Retrieved on: 
Friday, May 7, 2021
Psychoactive drugs, Stimulants, Nootropics, Norepinephrine-dopamine reuptake inhibitors, Euphoriants, Ergogenic aids, Controlled Substances Act, Methylphenidate, Pemoline, Dexmethylphenidate, Schedule 4, Schedule 2

AZSTARYS is classified as a Schedule II controlled substance as it includes a 70:30 mixture of SDX (Schedule IV) and d-MPH (Schedule II), respectively.\nAccording to the \xe2\x80\x9cSchedules of Controlled Substances: Placement of Serdexmethylphenidate in Schedule IV,\xe2\x80\x9d which has been published in the Federal Register (federalregister.gov/d/2021-09738), the DEA concluded that SDX meets the 21 U.S.C.

Key Points: 
  • AZSTARYS is classified as a Schedule II controlled substance as it includes a 70:30 mixture of SDX (Schedule IV) and d-MPH (Schedule II), respectively.\nAccording to the \xe2\x80\x9cSchedules of Controlled Substances: Placement of Serdexmethylphenidate in Schedule IV,\xe2\x80\x9d which has been published in the Federal Register (federalregister.gov/d/2021-09738), the DEA concluded that SDX meets the 21 U.S.C.
  • 812(b)(4) criteria for placement in schedule IV of the Controlled Substances Act (CSA).
  • \xe2\x80\x9cKP879, which is intended for the treatment of stimulant use disorder, is based on SDX as the sole API.
  • KemPharm\xe2\x80\x99s lead clinical development candidate for the treatment of SUD, KP879, is based on its prodrug of d-methylphenidate, known as serdexmethylphenidate (SDX).

U.S. Food and Drug Administration Approves Novel Once-Daily Capsule AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate), First and Only Product Containing Dexmethylphenidate Prodrug for ADHD in Patients Age 6 Years and Older

Retrieved on: 
Wednesday, March 3, 2021
Psychoactive drugs, Methylphenidate, Nootropics, Norepinephrine-dopamine reuptake inhibitors, Piperidines, Stimulants, Dexmethylphenidate, Attention deficit hyperactivity disorder, Placebo-controlled study, Attention deficit hyperactivity disorder management

AZSTARYS contains 30 percent immediate-release d-MPH and 70 percent extended-release novel SDX, a prodrug of d-MPH.

Key Points: 
  • AZSTARYS contains 30 percent immediate-release d-MPH and 70 percent extended-release novel SDX, a prodrug of d-MPH.
  • Corium, a wholly-owned portfolio company of Gurnet Point Capital (GPC), will be leading the U.S. commercialization activities for AZSTARYS.
  • AZSTARYS was evaluated in a multicenter, double-blind, randomized, placebo-controlled, laboratory classroom phase 3 study in 150 children aged 6 to 12 years diagnosed with ADHD (NCT03292952).
  • Do not take AZSTARYS if you or your child are:
    allergic to serdexmethylphenidate, methylphenidate, or any of the ingredients in AZSTARYS.

KemPharm’s KP415 and Serdexmethylphenidate (SDX) Prodrug to be Featured in Multiple Sessions at the 2021 APSARD Virtual Conference

Retrieved on: 
Thursday, January 14, 2021
Psychoactive drugs, Stimulants, Food and Drug Administration, Nootropics, Methylphenidate, Norepinephrine-dopamine reuptake inhibitors, Prescription Drug User Fee Act, Attention deficit hyperactivity disorder, New Drug Application, Drug, Dexmethylphenidate, Attention deficit hyperactivity disorder management

The 2021 APSARD Virtual Conference (APSARD 2021) is being be held January 15-17, 2021.

Key Points: 
  • The 2021 APSARD Virtual Conference (APSARD 2021) is being be held January 15-17, 2021.
  • KP415 is KemPharms investigational product candidate for the treatment of attention deficit hyperactivity disorder (ADHD).
  • Serdexmethylphenidate (SDX) is KemPharms prodrug of d-methylphenidate (d-MPH).
  • A New Drug Application (NDA) for KP415 is currently under review with the U.S. Food and Drug Administration (FDA) with an anticipated PDUFA date of March 2, 2021.

KemPharm Participating in BIO @ JPM and Fierce JPM Week 2021 Virtual Events During “J.P. Morgan Week 2021”

Retrieved on: 
Wednesday, January 13, 2021
Psychoactive drugs, Stimulants, Euphoriants, Nootropics, Piperidines, Phenethylamines, Methylphenidate, Benzhydrocodone, Dexmethylphenidate, Attention deficit hyperactivity disorder, Serdexmethylphenidate, Hydrocodone

KP415 consists of serdexmethylphenidate (SDX), KemPharms prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH.

Key Points: 
  • KP415 consists of serdexmethylphenidate (SDX), KemPharms prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH.
  • KemPharms prodrug product candidate pipeline is focused on the high need areas of attention deficit hyperactivity disorder, or ADHD, and stimulant use disorder.
  • In addition, KemPharm has received FDA approval for APADAZ, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen.
  • KemPharm is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

KemPharm’s KP415 and Serdexmethylphenidate (SDX) Prodrug to be Featured in Multiple Sessions at the AACAP 2020 Virtual Meeting

Retrieved on: 
Thursday, October 22, 2020
Psychoactive drugs, Nootropics, Stimulants, Amphetamine, Methylphenidate, Attention deficit hyperactivity disorder, Dexmethylphenidate, Attention deficit hyperactivity disorder management, Attention deficit hyperactivity disorder controversies

KP415 is KemPharms investigational product candidate for the treatment of attention deficit hyperactivity disorder (ADHD).

Key Points: 
  • KP415 is KemPharms investigational product candidate for the treatment of attention deficit hyperactivity disorder (ADHD).
  • Serdexmethylphenidate (SDX) is KemPharms prodrug of d-methylphenidate (d-MPH).
  • KemPharms prodrug product candidate pipeline is focused on the high need areas of attention deficit hyperactivity disorder, or ADHD, and stimulant use disorder.
  • KemPharms co-lead clinical development candidates for the treatment of ADHD, KP415 and KP484, are both based on a prodrug of d-methylphenidate, but have differing duration/effect profiles.