Methylphenidate

Adlon Therapeutics L.P. Announces Two New Publications of Adhansia XR® (methylphenidate HCl) Extended-Release Capsules CII Data

Retrieved on:

Wednesday, November 18, 2020

Biotechnology, Pharmaceutical, Health, Psychoactive drugs, Drugs, Psychoanaleptics, Stimulants, Phenethylamines, Euphoriants, Nootropics, Ergogenic aids, Methylphenidate, Amphetamine, Purdue Pharma, Boxed warning, Adhansia XR®, Adlon Therapeutics L.P.

Adlon Therapeutics L.P., a subsidiary of Purdue Pharma L.P., announced two recent online publications of studies related to the efficacy, safety and pharmacokinetics of Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII (investigationally known as PRC-063).

Key Points:

Adlon Therapeutics L.P., a subsidiary of Purdue Pharma L.P., announced two recent online publications of studies related to the efficacy, safety and pharmacokinetics of Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII (investigationally known as PRC-063).
The Full Prescribing Information for Adhansia XR contains a Boxed Warning emphasizing that CNS stimulants, including Adhansia XR, other methylphenidate-containing products, and amphetamines have a high potential for abuse and dependence.
Adhansia XR is not appropriate for all patients, and healthcare professionals should work with their patients to determine the most appropriate treatment option.
Adhansia XR is contraindicated in patients with a known hypersensitivity to methylphenidate or other components of Adhansia XR.

MindMed Receives Approval of Protocol Design to Evaluate Microdoses of LSD For Adult ADHD In Phase 2a Clinical Trial from Swiss and Dutch Health Authorities

Retrieved on:

Monday, November 16, 2020

Health sciences, Health, Clinical research, Pharmacology, Amphetamine, Methylphenidate, Childhood psychiatric disorders, Design of experiments, Lysergic acid diethylamide, Clinical trial, Attention deficit hyperactivity disorder, Microdosing

MindMed's Phase 2a Proof of Concept study evaluating microdoses of LSD for the treatment of Adult ADHD has successfully reached an agreement on the study protocol with both the Swiss and Dutch health authorities.

Key Points:

MindMed's Phase 2a Proof of Concept study evaluating microdoses of LSD for the treatment of Adult ADHD has successfully reached an agreement on the study protocol with both the Swiss and Dutch health authorities.
MindMed's clinical and technical operation teams are in the process of producing and preparing the GMP LSD material necessary to begin dosing for the Phase 2a commercial drug trial.
J.R. Rahn, MindMed co-founder and co-CEO said: "We are very pleased with the positive response from the Swiss and Dutch regulators on our protocol design evaluating microdoses of LSD for Adult ADHD in our planned Phase 2a trial.
MindMed in partnership with the Liechti Lab will conduct this interim analysis of the Phase 2a clinical trial data in Q1 2021.

HMP Global Announces Agenda for 3rd Annual Cocaine, Meth & Stimulant Summit

Retrieved on:

Thursday, November 12, 2020

Psychoactive drugs, Branches of biology, Medical specialties, Psychiatric diagnosis, Attention deficit hyperactivity disorder, Amphetamine, Methylphenidate, Childhood psychiatric disorders, Stimulant, Cocaine, Clinical

This comprehensive meeting is the country's only educational event providing clinical, law enforcement, and public safety professionals with practical strategies and solutions to address the national stimulant crisis.

Key Points:

This comprehensive meeting is the country's only educational event providing clinical, law enforcement, and public safety professionals with practical strategies and solutions to address the national stimulant crisis.
Despite these staggering statistics, there are not currently any medications approved by the U.S. Food and Drug Administration (FDA) to treat stimulant use disorder.
"As such, the Cocaine, Meth & Stimulant Summit provides a fundamental and extensive educational experience for professionals on the frontlines of this rising epidemic as we collaborate toward solutions and change.
HMP Global is the force behind Healthcare Made Practical and is a multichannel leader in healthcare events and education, with a mission to improve patient care.

Tris Pharma Launches New ADHD Portfolio Website for Patients and Caregivers

Retrieved on:

Tuesday, November 10, 2020

Human activities, Childhood psychiatric disorders, Psychiatry, Abnormal psychology, Amphetamine, Methylphenidate, Psychiatric diagnosis, Educational psychology, Attention deficit hyperactivity disorder, Caregiver

Given the large impact of the disorder, there's a need for ongoing education and access to resources that may help inform patients and caregivers about symptom management.

Key Points:

Given the large impact of the disorder, there's a need for ongoing education and access to resources that may help inform patients and caregivers about symptom management.
Tris' new website addresses this need within the ADHD community.
With the launch of this new resource, patients and caregivers can learn more about ADHD and the multiple treatment options that are available from Tris.
Tris' ADHD Portfolio Website for Patients and Caregivers: https://www.trisadhd.com/
"The launch of our new consumer website is another example of Tris' continued commitment to educating people about ADHD," said Michelle Perlman, Senior Director of Marketing.

American BriVision Issues Clinical Study Report for Phase II Part I Clinical Trial for ABV-1505 in Adult Attention-Deficit Hyperactivity Disorder (ADHD)

Retrieved on:

Monday, November 9, 2020

Health, Childhood psychiatric disorders, Amphetamine, Methylphenidate, Clinical research, Pharmaceutical industry, Articles, Attention deficit hyperactivity disorder, Clinical trial

Additionally, PDC-1421, the active pharmaceutical ingredient of ABV-1505, had been used recently in a Phase II clinical study conducted at Stanford University to successfully treat Major Depression Disorder (MDD).

Key Points:

Additionally, PDC-1421, the active pharmaceutical ingredient of ABV-1505, had been used recently in a Phase II clinical study conducted at Stanford University to successfully treat Major Depression Disorder (MDD).
The Phase II Part I clinical study for treating ADHD found that the PDC-1421 Capsule was safe, well-tolerated and efficacious during its treatment and follow-up period with six adult patients.
Overall, the results from this study, which demonstrate the therapeutic value of PDC-1421, support further clinical development of ABV-1505 for the treatment of adult ADHD.
We expect the Phase II Part II trial of ABV-1505 to commence in Q2 of 2021 at UCSF and major medical centers in Taiwan.

Cingulate Therapeutics Presents Results of Pivotal Phase 2 Clinical Trial for Lead ADHD Candidate CTx-1301 at the American Association of Child and Adolescent Psychiatry Annual Meeting

Retrieved on:

Monday, October 26, 2020

Psychoactive drugs, Stimulants, Phenethylamines, AACAP, Childhood psychiatric disorders, Amphetamine, Methylphenidate, Attention deficit hyperactivity disorder, Pemoline, Child and adolescent psychiatry

These results demonstratedthe comparative bioavailability (bridging) between these two products, confirming the 505(b)(2) pathway.

Key Points:

These results demonstratedthe comparative bioavailability (bridging) between these two products, confirming the 505(b)(2) pathway.
The data was presented at the American Association of Child and Adolescent Psychiatry (AACAP) annual virtual meeting October 12-24, 2020.
"The data is impressive and will help position Cingulate's CTx-1301 product to achieve rapid market uptake," said Shane J. Schaffer, PharmD, Chairman and CEO of Cingulate Therapeutics.
Our Phase 3 trials are designed to further confirm the pharmacokinetic-pharmacodynamic relationship of stimulants for ADHD.

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.

NeuroSigma Announces Publication of ADHD Clinical Trial Data That Provide Additional eTNS Mechanism of Action

Retrieved on:

Thursday, October 22, 2020

Neuroscience, Branches of biology, Cognitive neuroscience, Amphetamine, Methylphenidate, Psychiatric diagnosis, Neuroimaging, European Telephony Numbering Space, Psychiatry, Attention deficit hyperactivity disorder, Functional neuroimaging

The paper presents results of research conducted at UCLA as part of the pivotal trial of external TNS (eTNS) for pediatric ADHD that supported NeuroSigma's FDA clearance of the Monarch eTNS System.

Key Points:

The paper presents results of research conducted at UCLA as part of the pivotal trial of external TNS (eTNS) for pediatric ADHD that supported NeuroSigma's FDA clearance of the Monarch eTNS System.
"Specifically, the mechanism of action was demonstrated by the treatment-induced changes in frontal brain activity that showed a correlation with clinical outcome.
Functional neuroimaging data suggests the mechanism of action of TNS is related to its ability to modulate activity in targeted brain regions.
eTNS, Monarch, and Monarch eTNS are trademarks of NeuroSigma, Inc.
For more information on eTNS, please visit the Monarch eTNS website .

Researchers Present New Outcome Data for Akili Digital Therapeutic EndeavorRx™ in Pediatric ADHD

Retrieved on:

Wednesday, October 21, 2020

Also presented were analyses across four clinical trials of EndeavorRx, evaluating the impact of treatment on childrens attention function compared to normative ranges.

Key Points:

Also presented were analyses across four clinical trials of EndeavorRx, evaluating the impact of treatment on childrens attention function compared to normative ranges.
EndeavorRx is an FDA-cleared digital treatment for children diagnosed with ADHD.
EndeavorRx is not intended to be used as a stand-alone therapeutic and is not a substitution for a childs medication.
Akili is pioneering the development of digital treatments and care solutions to help people affected by cognitive impairments.

COVID-19, ADHD, and Depression: During ADHD Awareness Month in October, CHADD Shines a Spotlight on the Heightened Impact of the Pandemic on Children and Adults with ADHD

Retrieved on:

Tuesday, October 20, 2020

Articles, Psychiatry, Mind, Childhood psychiatric disorders, Amphetamine, Methylphenidate, Educational psychology, Attention deficit hyperactivity disorder, Animation Domination High-Def, Attention deficit hyperactivity disorder controversies, Adult ADHD Self-Report Scale

"During the best of times, individuals with ADHD can face significant challenges in school, work, and relationships.

Key Points:

"During the best of times, individuals with ADHD can face significant challenges in school, work, and relationships.
Nearly 38 percent of adults with ADHD experience depression, compared to eight percent of the general adult population.
And approximately 17 percent of children with ADHD experience depression, compared to only three percent of their non-ADHD peers.
"Living with ADHD can be challenging in itself, and often goes hand-in-hand with depression," said Robert Cattoi, Chief Executive Officer, CHADD.