Attention deficit hyperactivity disorder management

Eagle Telemedicine Expands Specialty Telemedicine Services with Pediatric TeleNeurology Program

Retrieved on: 
Wednesday, April 12, 2023

ATLANTA, April 12, 2023 /PRNewswire-PRWeb/ -- Eagle Telemedicine, the leader in technology-enabled inpatient and outpatient care for sustainable healthcare resilience, today announced that it has expanded its suite of telemedicine specialties to include Pediatric TeleNeurology. This new telemedicine program is added to Eagle Telemedicine's more than 17 healthcare specialty programs and joins a growing list of specialties for pediatric care.

Key Points: 
  • This new telemedicine program is added to Eagle Telemedicine's more than 17 healthcare specialty programs and joins a growing list of specialties for pediatric care.
  • "With the release of our Pediatric TeleNeurology program, Eagle is increasing access to this critical pediatric specialty," said Jason Povio, President and Chief Operating Officer, Eagle Telemedicine.
  • Eagle Pediatric TeleNeurology services complement Eagle's inpatient and outpatient telemedicine programs for pediatrics and neurology which also include TelePediatrics and Tele-NICU programs.
  • For more information on Eagle Pediatric TeleNeurology services and other telemedicine specialties, visit https://www.eagletelemedicine.com/telemedicine-services/telemedicine-spe... .

Noramco Announces Submission and Reactivation of the Drug Master File for Active Pharmaceutical Ingredient Methylnaltrexone Bromide

Retrieved on: 
Tuesday, November 1, 2022

Noramco, LLC, a leading North American producer of controlled substance and specialty bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, today announced it has reactivated its previously filed Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for the active pharmaceutical ingredient methylnaltrexone bromide.

Key Points: 
  • Noramco, LLC, a leading North American producer of controlled substance and specialty bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, today announced it has reactivated its previously filed Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for the active pharmaceutical ingredient methylnaltrexone bromide.
  • Methylnaltrexone bromide is the active ingredient in Relistor, an FDA-approved prescription medication indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic pain.
  • Methylnaltrexone bromide is a significant advancement, providing relief for these patients who need to manage chronic pain with opioids.
  • Noramco, headquartered in Wilmington, Delaware, is a leading North American producer of controlled substances bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry.

Auxilius Raises $10 Million to Help Biopharma Manage $150 Billion in Clinical R&D Spend

Retrieved on: 
Thursday, June 16, 2022

The result is an evolving and growing shadow industry that emerging biopharma companies are ill-equipped to manage operationally.

Key Points: 
  • The result is an evolving and growing shadow industry that emerging biopharma companies are ill-equipped to manage operationally.
  • For clinical trial sponsors managing milestone to milestone, operational rigor and spend management are essential to extend the companys runway and help clinical teams achieve clinical outcomes.
  • Auxilius was purpose-built for companies like ours to manage clinical complexity, maintain alignment across clinical and financial stakeholders through change, and scale as our organization evolves.
  • This allows companies conducting clinical trials to take control over trial costs and clinical vendors, manage financial risk, and optimize spend in pursuit of trial targets.

Noramco Announces Submission of Drug Master File for Lisdexamfetamine Dimesylate ─ Active Pharmaceutical Ingredient

Retrieved on: 
Friday, December 3, 2021

Noramco, LLC, a leading North American producer of controlled substance bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, today announced it has submitted a Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for the active pharmaceutical ingredient lisdexamfetamine dimesylate (Lisdex/LDX).

Key Points: 
  • Noramco, LLC, a leading North American producer of controlled substance bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry, today announced it has submitted a Type II Drug Master File (DMF) to the U.S. Food and Drug Administration (FDA) for the active pharmaceutical ingredient lisdexamfetamine dimesylate (Lisdex/LDX).
  • The FDA acknowledged receipt of the submission on November 23, 2021.
  • Noramco has paid the DMF fee required under GDUFA and has completed GMP validation batches.
  • Noramco, headquartered in Wilmington, Delaware, is a leading North American producer of controlled substances bulk Active Pharmaceutical Ingredients (APIs) for the pharmaceutical industry.

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

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

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.

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

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

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

"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.

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

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.