Methylphenidate

KemPharm Announces U.S. Launch of Innovative ADHD Treatment AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate capsules) by Corium, Inc.

Retrieved on: 
Wednesday, July 21, 2021
Psychiatry, Amphetamine, Childhood psychiatric disorders, Methylphenidate, Psychiatric diagnosis, Abnormal psychology, Neuroscience, Attention deficit hyperactivity disorder

The U.S. commercial launch of AZSTARYS is a significant milestone for KemPharm and an important advancement in the treatment of ADHD, a disease indication that has seen little innovation in recent years, said Travis C. Mickle, Ph.D., President and CEO of KemPharm.

Key Points: 
  • The U.S. commercial launch of AZSTARYS is a significant milestone for KemPharm and an important advancement in the treatment of ADHD, a disease indication that has seen little innovation in recent years, said Travis C. Mickle, Ph.D., President and CEO of KemPharm.
  • Since the FDAs approval of AZSTARYS in March, the various teams across Corium have been working diligently to ready AZSTARYS for its U.S. launch.
  • We believe Corium has built a best-in-class commercial organization, and as a result, we expect the market potential for AZSTARYS will be maximized.
  • AZSTARYS is an FDA-approved, once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years or older.

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.

FDA Approves Supplemental New Drug Application for Adhansia XR® (methylphenidate HCl) Extended-Release Capsules CII

Retrieved on: 
Thursday, July 1, 2021
Biotechnology, FDA, Pharmaceutical, Health, Psychoactive drugs, Stimulants, Nootropics, Ergogenic aids, Euphoriants, Norepinephrine-dopamine reuptake inhibitors, Methylphenidate, Purdue Pharma, XR, Attention deficit hyperactivity disorder management

Adlon Therapeutics L.P., a subsidiary of Purdue Pharma L.P., announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the prescribing information for Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII.

Key Points: 
  • Adlon Therapeutics L.P., a subsidiary of Purdue Pharma L.P., announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the prescribing information for Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII.
  • Adhansia XR was approved by FDA for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients six years and older in February 2019.
  • Adhansia XR capsules contain identical beads which are formulated using the proprietary smart design MLR (Multi-Layer Release) technology.
  • Adhansia XR is contraindicated in patients with a known hypersensitivity to methylphenidate or other components of Adhansia XR.

Drug Relieves Persistent Daydreaming, Fatigue, and Brain Sluggishness in Adults with ADHD

Retrieved on: 
Tuesday, June 29, 2021
Attention deficit hyperactivity disorder, Psychiatry, Childhood psychiatric disorders, Branches of biology, Abnormal psychology, Educational psychology, Amphetamine, Methylphenidate, Sluggish cognitive tempo, Adult attention deficit hyperactivity disorder, Stimulant, Attention deficit hyperactivity disorder controversies

Adler, who directs the adult ADHD program at NYU Langone Health, says until now stimulants have only been shown to improve sluggish cognitive tempo symptoms in children with ADHD.

Key Points: 
  • Adler, who directs the adult ADHD program at NYU Langone Health, says until now stimulants have only been shown to improve sluggish cognitive tempo symptoms in children with ADHD.
  • The NYU Langone-Mount Sinai team's findings, he adds, are the first to show that such treatments also work in adults.
  • "These findings highlight the importance of assessing symptoms of sluggish cognitive tempo and executive brain function in patients when they are initially diagnosed with ADHD," says Adler.
  • Researchers then carefully tracked their psychiatric health on a weekly basis through standardized tests for signs and symptoms of sluggish cognitive tempo, ADHD, as well as other measures of brain function.

Adlon Therapeutics L.P. Announces Publication of Data from Adhansia XR® (methylphenidate HCl) Extended-Release Capsules CII Studies Examining Sleep Quality Outcomes in CNS Drugs

Retrieved on: 
Monday, June 14, 2021
General Health, Other Health, Health, Science, Research, Psychoactive drugs, Stimulants, Psychiatric diagnosis, Nootropics, Amphetamine, Methylphenidate, Attention deficit hyperactivity disorder, Insomnia, XR, Attention deficit hyperactivity disorder management, Adhansia XR®, Adlon Therapeutics L.P., ADHANSIA XR®, ADLON THERAPEUTICS L.P.

The studies evaluated the effect of Adhansia XR on sleep in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).

Key Points: 
  • The studies evaluated the effect of Adhansia XR on sleep in adults with Attention-Deficit/Hyperactivity Disorder (ADHD).
  • The most common sleep-related adverse events (AEs) in the double-blind study were headache (Adhansia XR, 17.5%; placebo, 11.5%), insomnia (Adhansia XR, 15.8%; placebo, 3.8%) and decreased appetite (Adhansia XR, 11.1%; placebo, 2.6%) for all doses combined.
  • Adhansia XR capsules contain identical beads which are formulated using the proprietary smart design MLR (Multi-Layer Release) technology.
  • Adhansia XR is contraindicated in patients with a known hypersensitivity to methylphenidate or other components of Adhansia XR.

New Study Finds ADHD Test Serves as a Better Indicator of Medication Effects

Retrieved on: 
Tuesday, June 8, 2021
Mental health, Health, Science, Pharmaceutical, Research, Attention deficit hyperactivity disorder, Psychiatry, Childhood psychiatric disorders, Psychology, Amphetamine, Abnormal psychology, Methylphenidate, Psychiatric diagnosis, Attention deficit hyperactivity disorder controversies, Attention deficit hyperactivity disorder management

The Quantified Behavioral Test (QbTest), serves as a better early indicator of treatment effects for ADHD, confirming that healthcare professionals can confidently use objective data alongside patient feedback regarding treatment effectiveness.

Key Points: 
  • The Quantified Behavioral Test (QbTest), serves as a better early indicator of treatment effects for ADHD, confirming that healthcare professionals can confidently use objective data alongside patient feedback regarding treatment effectiveness.
  • View the full release here: https://www.businesswire.com/news/home/20210608005305/en/
    Study finds ADHD test serves as a better early indicator of medication effects than rating scales (Graphic: Business Wire)
    Clinical ADHD treatment procedures typically involve self-rated evaluations of symptoms as a means for measuring medication effects in adults with ADHD.
  • At the first follow up, QbTests activity and inattention measures showed significant effect of medication, compared to ASRS, that indicated only moderate effect.
  • The study proves how important it is to have objective data when managing ADHD symptoms.

ADHD Medications Associated with Reduced Risk of Suicidality in Children with Significant Behavioral Symptoms

Retrieved on: 
Friday, June 4, 2021
Psychiatry, Abnormal psychology, Psychology, Attention deficit hyperactivity disorder, Childhood psychiatric disorders, Amphetamine, Psychiatric diagnosis, Methylphenidate, Externalizing disorders, Attention deficit hyperactivity disorder management, Attention deficit hyperactivity disorder controversies

"Early diagnosis and treatment of behavioral symptoms with ADHD medication, particularly among children with severe externalizing symptoms, may serve not only to improve learning and behavior problems, but also to decrease suicidality risk."

Key Points: 
  • "Early diagnosis and treatment of behavioral symptoms with ADHD medication, particularly among children with severe externalizing symptoms, may serve not only to improve learning and behavior problems, but also to decrease suicidality risk."
  • The researchers found that children expressing suicidal tendencies had more externalizing symptoms and were more likely to receive ADHD medication than non-suicidal children.
  • However, among children who demonstrated significant externalizing behaviors, those taking ADHD medications had lesser odds for suicidality, suggesting a moderating role for ADHD medications in these children.
  • They found that children with high externalizing symptoms who were treated with ADHD medications at baseline were less likely to be suicidal one year later.

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 .

Rapid Therapeutic Prepares to file Investigational New Drug Application for its CBD Metered Dose Inhaler with FDA

Retrieved on: 
Wednesday, June 2, 2021
Food and Drug Administration, Health, Drug Safety, Psychoactive drugs, Psychiatric diagnosis, Clinical research, Investigational New Drug, Methylphenidate, New Drug Application, Insomnia, Attention deficit hyperactivity disorder

RTSL entered into these two contracts in preparation for filing an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA).

Key Points: 
  • RTSL entered into these two contracts in preparation for filing an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA).
  • The planned studies will initially focus on therapeutic benefits of CBD relating to depression, anxiety, insomnia, ADHD and arthritis/chronic pain.
  • RTSL will need to file and obtain approval of the IND by the FDA to begin the planned studies.
  • RTSLs CEO, Donal R. Schmidt, Jr. stated, We made the decision to file an IND based upon a number of things.

Qelbree™ (viloxazine extended-release capsules), a New Non-Controlled Substance, Now Available for the Treatment of ADHD in Pediatric Patients 6-17 Years of Age

Retrieved on: 
Monday, May 24, 2021
Psychoactive drugs, Psychiatry, Attention deficit hyperactivity disorder, Amphetamine, Methylphenidate, Childhood psychiatric disorders, Educational psychology, Pemoline, Caregiver, Stimulant, Suicidal ideation, Attention deficit hyperactivity disorder management

Many of my patients and their caregivers seek non-stimulant options as we work together to develop a treatment regimen.

Key Points: 
  • Many of my patients and their caregivers seek non-stimulant options as we work together to develop a treatment regimen.
  • Supernus has developed a robust patient access program to support those who qualify for treatment.
  • As a non-controlled substance that has a unique profile of proven efficacy, safety, and tolerability, Qelbree provides patients living with ADHD a novel treatment option like no other ADHD medication.
  • Qelbree may increase suicidal thoughts and actions in some children with ADHD, especially within the first few months of treatment or when the dose is changed.