Methylphenidate

NLS Pharmaceutics to Participate in Upcoming Investor Conferences

Retrieved on: 
Thursday, February 25, 2021
Amphetamine, Methylphenidate, Childhood psychiatric disorders, Psychiatry, Health sciences, Health, Attention deficit hyperactivity disorder, Psychiatric diagnosis, NLS, Pharmaceutics

Maxim 2021 Emerging Growth Virtual Conference hosted by M-Vest on March 17, 2021.

Key Points: 
  • Maxim 2021 Emerging Growth Virtual Conference hosted by M-Vest on March 17, 2021.
  • The Company's presentation for this conference will be available on M-Vest following the conference.
  • NLS Pharmaceutics Ltd. is a Swiss-based clinical-stage biopharmaceutical company led by an experienced management team with a track record of developing and repurposing product candidates to treat rare and complex central nervous system disorders.
  • NLS completed a phase 2 study in the U.S. evaluating mazindol CR in adult subjects with ADHD.

Supernus Receives FDA Notice Assigning Early April 2021 PDUFA Date for SPN-812 NDA

Retrieved on: 
Monday, February 22, 2021
Amphetamine, Methylphenidate, Childhood psychiatric disorders, Psychiatry, Food and Drug Administration, United States Public Health Service, Attention deficit hyperactivity disorder, Health, Abnormal psychology

Supernus will continue to work closely with the FDA as it completes its review of the SPN-812 NDA.

Key Points: 
  • Supernus will continue to work closely with the FDA as it completes its review of the SPN-812 NDA.
  • If approved by the FDA, the Company is preparing for the commercial launch of SPN-812 for the treatment of ADHD in pediatric patients in the second quarter of 2021.
  • In December 2020, Supernus announced positive results from a Phase III study for SPN-812 in adults with ADHD.
  • The Company plans to submit a supplemental NDA (sNDA) to the FDA for SPN-812 for the treatment of ADHD in adult patients in the second half of 2021, assuming approval for pediatric patients.

APSARD and Tris Pharma Announce the 2021 Tris Research Award in ADHD

Retrieved on: 
Thursday, January 28, 2021
Amphetamine, Childhood psychiatric disorders, Psychiatry, Methylphenidate, Abnormal psychology, Educational psychology, Attention deficit hyperactivity disorder, Draft:World Federation of ADHD, Attention deficit hyperactivity disorder management

The Tris Research Award recognizes innovative research that facilitates a better understanding of the diagnosis, recognition and/or treatment of ADHD and related disorders.

Key Points: 
  • The Tris Research Award recognizes innovative research that facilitates a better understanding of the diagnosis, recognition and/or treatment of ADHD and related disorders.
  • APSARD is solely responsible for the management, decision making and oversight of this award.
  • The 2021 awards were chosen from all scientific posters presented at the 2021 APSARD Annual Meeting, held virtually on 15-17 January 2021.
  • The Organization works to improve the quality of care for ADHD patients through shared research, best practices, evidence-based education and training.

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.

Supernus Announces Positive Results from Phase III Study for SPN-812 in Adults with ADHD

Retrieved on: 
Tuesday, December 22, 2020
Health, Clinical research, Design of experiments, Articles, Amphetamine, Methylphenidate, Childhood psychiatric disorders, Clinical trial, Attention deficit hyperactivity disorder, Placebo-controlled study, Attention deficit hyperactivity disorder management, Attention deficit hyperactivity disorder controversies

SPN-812 is under review by the U.S. Food and Drug Administration (FDA) for the treatment of ADHD in pediatric patients 6 to 17 years of age.

Key Points: 
  • SPN-812 is under review by the U.S. Food and Drug Administration (FDA) for the treatment of ADHD in pediatric patients 6 to 17 years of age.
  • We now have positive Phase III data proving the efficacy and safety of SPN-812 in a broad range of ADHD patient populations; children 6-11 years old, adolescents 12-17 years old, and adults.
  • The study was a randomized, double-blind, placebo controlled, multicenter, parallel group clinical trial in adult patients diagnosed with ADHD.
  • Patients who completed the study were offered the opportunity to continue into an ongoing open-label safety extension study.

KemPharm Files IND for KP879 for the Treatment of Stimulant Use Disorder

Retrieved on: 
Tuesday, December 22, 2020
Psychoactive drugs, Amphetamine, Phenethylamines, Stimulants, Methylphenidate, Attention deficit hyperactivity disorder, Pemoline, Attention deficit hyperactivity disorder management, Attention deficit hyperactivity disorder controversies

KemPharm is developing KP879 as an extended-duration, agonist replacement therapy for the treatment of Stimulant Use Disorder (SUD).

Key Points: 
  • KemPharm is developing KP879 as an extended-duration, agonist replacement therapy for the treatment of Stimulant Use Disorder (SUD).
  • If the KP879 IND filing is accepted by the FDA, KemPharm intends to initiate efficacy studies of KP879 in 2021.
  • It is anticipated that certain data from previously completed KP415 research may be leveraged for KP879, including pharmacokinetic studies, which KemPharm believes could potentially streamline the development timeline of KP879.
  • KemPharms prodrug product candidate pipeline is focused on the high need areas of attention deficit hyperactivity disorder, or ADHD, and stimulant use disorder.

NeuroSigma's Monarch eTNS for Pediatric ADHD Featured in MD+DI's List of the 10 Wearable Medical Devices that Redefined Healthcare

Retrieved on: 
Friday, December 18, 2020
European Telephony Numbering Space, Amphetamine, Methylphenidate, Childhood psychiatric disorders, Psychiatry, Food and Drug Administration, Attention deficit hyperactivity disorder, Medical device, Health, Abnormal psychology, Exchange-traded note

NeuroSigma thanks MD+DI for its recognition of NeuroSigma's FDA cleared Monarch eTNS System for Pediatric ADHD in its list of the 10 FDA Cleared or Approved Wearable Medical Devices that Redefined Healthcare .

Key Points: 
  • NeuroSigma thanks MD+DI for its recognition of NeuroSigma's FDA cleared Monarch eTNS System for Pediatric ADHD in its list of the 10 FDA Cleared or Approved Wearable Medical Devices that Redefined Healthcare .
  • "NeuroSigma's Monarch eTNS System was the first non-drug treatment for pediatric ADHD cleared by the FDA.
  • This builds momentum for increased adoption and better awareness of the unique therapeutic advantages the Monarch eTNS System offers.
  • eTNS, Monarch, and Monarch eTNS are trademarks of NeuroSigma, Inc.
    For more information on eTNS, please visit the Monarch eTNS website .

KemPharm Participates in KP415 Late-Cycle Communication Meeting with FDA

Retrieved on: 
Wednesday, December 2, 2020
Psychoactive drugs, Euphoriants, Phenethylamines, Stimulants, Amphetamine, Methylphenidate, Benzhydrocodone, Attention deficit hyperactivity disorder, Hydrocodone, Pemoline, Drug, Attention deficit hyperactivity disorder management

KemPharms prodrug product candidate pipeline is focused on the high need areas of attention deficit hyperactivity disorder, or ADHD, and stimulant use disorder.

Key Points: 
  • 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.
  • In addition, KemPharm has received FDA approval 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 .

REMINDER: KemPharm and Corium to Co-Host “KP415 Market Opportunity and Commercialization Strategy” Investor Event

Retrieved on: 
Monday, November 30, 2020
Psychoactive drugs, Euphoriants, Stimulants, Phenethylamines, Morphinans, Amphetamine, Methylphenidate, Benzhydrocodone, Attention deficit hyperactivity disorder, Hydrocodone, Pemoline, Drug

KemPharms prodrug product candidate pipeline is focused on the high need areas of ADHD and stimulant use disorder.

Key Points: 
  • KemPharms prodrug product candidate pipeline is focused on the high need areas of 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.
  • In addition, KemPharm has received FDA approval 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 .