Childhood psychiatric disorders

KemPharm to Present at the 33rd Annual Roth Conference

Retrieved on: 
Thursday, March 4, 2021

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.

NLS Pharmaceutics to Participate in Upcoming Investor Conferences

Retrieved on: 
Thursday, February 25, 2021

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

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.

Baby Food Attorney Taking Cases for Parents of Kids with Autism and ADHD

Retrieved on: 
Wednesday, February 10, 2021

LOS ANGELES, Feb. 10, 2021 /PRNewswire/ -- The law firm of Baum Hedlund Aristei & Goldman is accepting toxic baby food lawsuit cases on behalf of parents of children with autism and ADHD who purchased foods from several leading brands.

Key Points: 
  • LOS ANGELES, Feb. 10, 2021 /PRNewswire/ -- The law firm of Baum Hedlund Aristei & Goldman is accepting toxic baby food lawsuit cases on behalf of parents of children with autism and ADHD who purchased foods from several leading brands.
  • These toxic metals are associated with autism, autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) in children.
  • The report also found that the companies knew their baby food products were tainted with high levels of toxic metals but decided to sell them anyway.
  • "The level of exposure to arsenic, lead, cadmium, and mercury known to be safe for infants is zero," attorney Pedram Esfandiary .

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

Retrieved on: 
Thursday, January 28, 2021

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.

NLS Pharmaceutics Ltd. Announces Notice of Allowance of a New Technology Patent Covering Attention Deficit Hyperactivity Disorder & Narcolepsy

Retrieved on: 
Thursday, January 21, 2021

On November 23, 2020, the Canadian Intellectual Property Office (CIPO) issued a similar notice of allowance for the counterpart Canadian application.

Key Points: 
  • On November 23, 2020, the Canadian Intellectual Property Office (CIPO) issued a similar notice of allowance for the counterpart Canadian application.
  • NLS awaits the impending grant of the European and Canadian patents.
  • 17724102, entitled "A MAZINDOL IR/SR MULTILAYER TABLET AND ITS USE FOR THE TREATMENT OF ATTENTION DEFICIT/HYPERACTIVITY DISORDER (ADHD)", has been examined and allowed for issuance as a patent by the EPO on January 21, 2021.
  • This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws.

The American Institute For Stuttering Elects Five New Board Members And Expands Geographical Reach

Retrieved on: 
Thursday, January 14, 2021

These new members will act as ambassadors of AIS nationally and globally to propel its core mission of providing affordable, effective stuttering therapy to children and adults.

Key Points: 
  • These new members will act as ambassadors of AIS nationally and globally to propel its core mission of providing affordable, effective stuttering therapy to children and adults.
  • "We are delighted to welcome Christopher Coleridge, Kerri Chace, Julie Henson, William Marsillo, and Amish Shah to the AIS Board," said Eric Dinallo, president of the AIS Board of Directors.
  • "Each new member brings important and diverse skill sets to the table, and shares the same goal of ensuring that impactful stuttering therapy is available to all people, at every socio-economic level.
  • As we head into the new year, we anticipate a time of tremendous growth and opportunity for the organization with our new members taking an active role."

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

Retrieved on: 
Tuesday, December 22, 2020

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.

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

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 .

Results from Axial Therapeutics Phase 1b/2a Study of AB-2004 in Adolescents with Autism Spectrum Disorder Met Primary Endpoint and Reduced Irritability and Other Symptoms

Retrieved on: 
Thursday, December 3, 2020

The findings from the open-label clinical study demonstrated that AB-2004, Axials first-in-class, orally administered therapeutic, met the primary endpoint demonstrating safety, tolerability and adherence with no drug-related adverse events.

Key Points: 
  • The findings from the open-label clinical study demonstrated that AB-2004, Axials first-in-class, orally administered therapeutic, met the primary endpoint demonstrating safety, tolerability and adherence with no drug-related adverse events.
  • Specifically, the data showed that AB-2004 reduced several key GI neuroactive microbial metabolites (NMMs) measured in plasma and urine.
  • The Phase 1b/2a study evaluated the safety and tolerability of AB-2004 in males aged 12 to 17 with autism spectrum disorder (ASD) across three sites in Australia and New Zealand.
  • Each subject had a confirmed diagnosis of autism via the Autism Diagnostic Observation Schedule (ADOS) and suffered from GI symptoms.