Methylphenidate

KemPharm Announces Serdexmethylphenidate (SDX) Has Been Classified as a Schedule IV Controlled Substance by the DEA

Friday, May 7, 2021 - 12:30pm

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).

Large Study Analyzes Two Different Classes of ADHD Drugs in Preschool-Age Children

Tuesday, May 4, 2021 - 10:30pm

The researchers found that both classes of drugs have benefits, with differing side effects, suggesting that decisions on which class of drugs to prescribe should be made based on individual patient factors.

Key Points: 
  • The researchers found that both classes of drugs have benefits, with differing side effects, suggesting that decisions on which class of drugs to prescribe should be made based on individual patient factors.
  • In contrast, children aged 5 to younger than 6 prescribed were likely to continue using the medication for longer if they were prescribed a stimulant.
  • "Future research should seek to learn more about the use of these classes of drugs in preschool-age children so that we can prescribe the most effective therapy for each patient.
  • In addition, its unique family-centered care and public service programs have brought the 595-bed hospital recognition as a leading advocate for children and adolescents.

OWP Pharmaceuticals Announces Patent Application for the First-Ever Oral Liquid Formulation of Atomoxetine Hydrochloride for the Treatment of Attention Deficit Hyperactivity Disorder

Thursday, April 22, 2021 - 1:00pm

b"NAPERVILLE, Ill., April 22, 2021 (GLOBE NEWSWIRE) -- OWP Pharmaceuticals, Inc. is a privately held, commercial-stage neuroscience specialty pharmaceutical company, dedicated to developing and commercializing novel oral liquid formulations.

Key Points: 
  • b"NAPERVILLE, Ill., April 22, 2021 (GLOBE NEWSWIRE) -- OWP Pharmaceuticals, Inc. is a privately held, commercial-stage neuroscience specialty pharmaceutical company, dedicated to developing and commercializing novel oral liquid formulations.
  • OWP announced today that it has submitted for U.S. patent protection, for the first-ever oral suspension of atomoxetine hydrochloride.
  • The medication is widely prescribed by healthcare providers in psychiatry for ADHD, and it is indicated for treatment in children 6 years and older and adults.
  • Some individuals with ADHD also display difficulty regulating emotions or problems with executive function.

KemPharm Confirms Receipt of $10 Million Milestone Payment for FDA Approval of AZSTARYS™ Per License Agreement with Affiliate of Gurnet Point Capital

Wednesday, April 21, 2021 - 9:45pm

AZSTARYS was approved by the U.S. Food and Drug Administration (FDA) on March 2, 2021.

Key Points: 
  • AZSTARYS was approved by the U.S. Food and Drug Administration (FDA) on March 2, 2021.
  • The next regulatory milestone payment related to AZSTARYS is $10 million within thirty (30) days following the scheduling determination of SDX, the prodrug component of AZSTARYS, by the U.S. Drug Enforcement Administration (DEA).
  • Since approval, we have significantly ramped-up our commercialization activities to prepare for a successful launch,\xe2\x80\x9d said Perry Sternberg, Corium\xe2\x80\x99s President and CEO.
  • 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\xc2\xa0(SDX).

Supernus Announces FDA Approval of Qelbree™ (SPN-812) for the Treatment of ADHD

Friday, April 2, 2021 - 9:58pm

Based on the efficacy demonstrated in the clinical program, we believe Qelbree offers a unique new alternative for the treatment of ADHD, said Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals.

Key Points: 
  • Based on the efficacy demonstrated in the clinical program, we believe Qelbree offers a unique new alternative for the treatment of ADHD, said Jack A. Khattar, President and Chief Executive Officer of Supernus Pharmaceuticals.
  • Qelbree provides prescribing physicians and patients living with ADHD a therapy that is not a controlled substance with proven efficacy and a tolerable safety profile.
  • This approval offers a novel once a day sprinkleable non-stimulant that can be a great option for children and adolescents with ADHD.
  • Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.

PureTech Founded Entity Akili Announces the Results of EndeavorRx™ Clinical Study in Pediatric ADHD Published in Nature Digital Medicine

Friday, March 26, 2021 - 12:07pm

The results have been published in the international peer-reviewed journal, Nature Digital Medicine.

Key Points: 
  • The results have been published in the international peer-reviewed journal, Nature Digital Medicine.
  • The results have been published in the international peer-reviewed journal, Nature Digital Medicine.
  • Building on the results of the STARS-ADHD pivotal study of EndeavorRx published in The Lancet Digital Health in February 2020, the STARS Adjunct study evaluated the safety and efficacy of EndeavorRx when used alone and alongside stimulants.
  • EndeavorRx has been studied in more than 600 children with ADHD across five clinical trials, including a large, multicenter prospective randomized controlled study.

Results of Akili’s EndeavorRx™ Clinical Study Published in Nature Digital Medicine, Demonstrate Improvements in Pediatric ADHD Impairments and Symptoms in Daily Life

Friday, March 26, 2021 - 12:00pm

Statistically significant improvement was demonstrated in all predetermined endpoints of the study, which included parent and clinician ratings of childrens ADHD symptoms and related impairments in daily life.

Key Points: 
  • Statistically significant improvement was demonstrated in all predetermined endpoints of the study, which included parent and clinician ratings of childrens ADHD symptoms and related impairments in daily life.
  • Standard clinician ratings of impairments and symptoms were measured, as well as ratings by parents of their children in daily life.
  • A change in the ADHD Impairment Rating Scale (IRS), a parent-reported assessment scale of ADHD- specific impairments observed in their childs day-to-day life, was the primary outcome measure of the study.
  • EndeavorRx has been studied in more than 600 children with ADHD across five clinical trials, including a large, multicenter prospective randomized controlled study.

CHADD Honors Exceptional Contributions to the ADHD Community with Annual Awards

Monday, March 8, 2021 - 4:00pm

The 2020 Affiliate of the Year Award has been presented to CHADD Philadelphia in recognition of outstanding service to the community.

Key Points: 
  • The 2020 Affiliate of the Year Award has been presented to CHADD Philadelphia in recognition of outstanding service to the community.
  • Hall of Fame honorees are recognized for their leadership, innovation, and dedication to serving the ADHD community; their exceptional contributions to the field; and their steadfast commitment to CHADD.
  • The Lifetime Achievement Award is CHADD's highest honor, created to recognize sustained, fundamental, and outstanding contributions to the field of ADHD.
  • "We celebrate the exceptional contributions all of our 2020 award recipients have made to the ADHD community," said Robert Cattoi, Chief Executive Officer, CHADD.

KemPharm to Present at the 33rd Annual Roth Conference

Thursday, March 4, 2021 - 9:41pm

The complete label for AZSTARYS, including prescribing information and important safety information, may be found at https://kempharm.com/wp-content/uploads/2021/03/AZSTARYS-Master-Label-Fi... .

Key Points: 
  • The complete label for AZSTARYS, including prescribing information and important safety information, may be found at https://kempharm.com/wp-content/uploads/2021/03/AZSTARYS-Master-Label-Fi... .
  • KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LAT (Ligand Activated Therapy) technology.
  • KemPharm is also advancing several clinical development candidates, including KP484 for the treatment of ADHD and KP879 for the treatment of Stimulant Use Disorder (SUD).
  • In addition, KemPharm has received FDA approval for APADAZ, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen.

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

Wednesday, March 3, 2021 - 8:41pm

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.