Norepinephrine-dopamine reuptake inhibitors

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.

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 Submits KP415 NDA to the FDA for the Treatment of ADHD

Retrieved on: 
Monday, March 2, 2020
Psychoactive drugs, Methylphenidate, Stimulants, Nootropics, Norepinephrine-dopamine reuptake inhibitors, RTT, Dexmethylphenidate, Attention deficit hyperactivity disorder, Drug, Food and Drug Administration

KP415 is KemPharms product candidate for the treatment of attention deficit hyperactivity disorder (ADHD) which contains serdexmethylphenidate (SDX), KemPharms prodrug of d-methylphenidate (d-MPH).

Key Points: 
  • KP415 is KemPharms product candidate for the treatment of attention deficit hyperactivity disorder (ADHD) which contains serdexmethylphenidate (SDX), KemPharms prodrug of d-methylphenidate (d-MPH).
  • Submission of the KP415 NDA is a significant milestone for KemPharm as we seek FDA approval for our first ADHD product candidate based on our proprietary LAT prodrug technology, said Travis C. Mickle, Ph.D., President and CEO of KemPharm.
  • The license agreement provides that a regulatory milestone payment will be payable to KemPharm thirty (30) days following FDA acceptance of the KP415 NDA.
  • We look forward to working with the FDA as they complete their review of the KP415 NDA, Dr. Mickle concluded.

Dr. Reddy's Laboratories announces the launch of Bupropion Hydrochloride Extended-Release Tablets, USP (SR) in the U.S. Market

Retrieved on: 
Thursday, September 5, 2019
General Health, Pharmaceutical, Health, Psychoactive drugs, Drugs, Chemical compounds, RTT, Antidepressants, Chloroarenes, Norepinephrine-dopamine reuptake inhibitors, Nicotinic antagonists, Bupropion, Attention deficit hyperactivity disorder management

Dr. Reddys Bupropion Hydrochloride Extended-Release Tablets, USP (SR) are available as 150 mg dosage strength in bottle count sizes of 60.

Key Points: 
  • Dr. Reddys Bupropion Hydrochloride Extended-Release Tablets, USP (SR) are available as 150 mg dosage strength in bottle count sizes of 60.
  • Although bupropion hydrochloride extended-release tablets (SR) is not indicated for treatment of depression, it contains the same active ingredient as the antidepressant medications WELLBUTRIN, WELLBUTRIN SR, and WELLBUTRIN XL.
  • Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials.
  • In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors.

Methylphenidate Hydrochloride (CAS 298-59-9) Market Research Report 2019 - ResearchAndMarkets.com

Retrieved on: 
Thursday, May 23, 2019
Health, Pharmaceutical, Psychoactive drugs, Stimulants, Norepinephrine-dopamine reuptake inhibitors, Piperidines, RTT, Euphoriants, Methylphenidate, Ethylphenidate

The "Methylphenidate hydrochloride (CAS 298-59-9) Market Research Report 2019" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Methylphenidate hydrochloride (CAS 298-59-9) Market Research Report 2019" report has been added to ResearchAndMarkets.com's offering.
  • This Global Report 2019 is a result of industry experts' diligent work on Researching the world market of Methylphenidate hydrochloride.
  • The forth chapter deals with Methylphenidate hydrochloride market trends review, distinguish Methylphenidate hydrochloride manufacturers and suppliers.
  • The Methylphenidate hydrochloride global market Report 2019 key points:

Lannett To Launch Generic Concerta®, AB-rated Methylphenidate Hydrochloride ER Tablets

Retrieved on: 
Tuesday, April 30, 2019
Psychoactive drugs, Euphoriants, RTT, Nootropics, Norepinephrine-dopamine reuptake inhibitors, Piperidines, Methylphenidate, Tablet computer

PHILADELPHIA, April 30, 2019 /PRNewswire/ --Lannett Company, Inc. (NYSE: LCI) today announced that it expects to launch later this quarter Methylphenidate Hydrochloride Extended Release (ER) tablets USP (CII) in 18 mg, 27 mg, 36 mg and 54 mg strengths, an AB-rated generic equivalent to the brand Concerta.

Key Points: 
  • PHILADELPHIA, April 30, 2019 /PRNewswire/ --Lannett Company, Inc. (NYSE: LCI) today announced that it expects to launch later this quarter Methylphenidate Hydrochloride Extended Release (ER) tablets USP (CII) in 18 mg, 27 mg, 36 mg and 54 mg strengths, an AB-rated generic equivalent to the brand Concerta.
  • Total U.S. sales of Methylphenidate Hydrochloride ER tablets were approximately $1.4 billion for the 12 months ended February 2019, according to IQVIA, although actual generic market values are expected to be lower.
  • "The market for AB-rated Methylphenidate is sizable," said Tim Crew, chief executive officer of Lannett.
  • In August 2018, Lannett announced that it entered into a licensing agreement with Andor for Methylphenidate Hydrochloride ER tablets.

Concerta - Drug Insight, 2019 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 12, 2019
Health, Mental health, Pharmaceutical, Psychoactive drugs, Drugs, Organic compounds, Nootropics, Norepinephrine-dopamine reuptake inhibitors, Piperidines, Stimulants, Methylphenidate, Vasoconstrictors

The "Concerta - Drug Insight, 2019" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Concerta - Drug Insight, 2019" report has been added to ResearchAndMarkets.com's offering.
  • Concerta Drug Insight, 2019 highlights the drug marketed details and the Global API Manufacturers details across the globe along with the location.
  • A review of the Concerta, based on information derived from company and industry-specific sources
    Product details on the basis of MOA, target, dosage, route of administration, molecule type, strength, Chemical type and ATC Classification