abuse-deterrent amphetamine immediate-release (ADAIR) / GRI Bio - LARVOL DELTA

SEAL: Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR) (clinicaltrials.gov) - P1; N=55; Completed; Sponsor: Vallon Pharmaceuticals, Inc.; Recruiting ➔ Completed; Trial completion date: Mar 2022 ➔ Dec 2021; Trial primary completion date: Mar 2022 ➔ Dec 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Narcolepsy • Psychiatry • Sleep Disorder

SEAL: Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR) (clinicaltrials.gov) - P1; N=64; Recruiting; Sponsor: Vallon Pharmaceuticals, Inc.; Trial completion date: Sep 2021 ➔ Mar 2022; Trial primary completion date: Sep 2021 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Narcolepsy • Psychiatry • Sleep Disorder

Vallon Pharmaceuticals Provides Update on Recent Pipeline and Corporate Advancements (GlobeNewswire) - "Vallon Pharmaceuticals, Inc...today provided an update on the progress of its development programs, ADAIR and ADMIR...'we are pleased to have achieved approximately 75% of target subject completion. We have implemented additional recruiting initiatives which have bolstered our enrollment efforts. Our team continues to advance toward the completion of enrollment and treatment of all subjects, now targeted for the first quarter of 2022, with topline results expected shortly thereafter...'"

Enrollment status • CNS Disorders • Narcolepsy • Sleep Disorder

Vallon Pharmaceuticals Announces Issuance of New European Patent Covering Method of Use and Composition of Matter for ADAIR (GlobeNewswire) - "Vallon Pharmaceuticals...announced that the European Patent Office has issued patent number EP3576719B1 covering ADAIR....Under the terms of the agreement, Vallon will receive development and sales milestone payments and double-digit sales-based royalty payments....The new European patent covers composition of matter and method of use for ADAIR, with a base patent term extending until 2038."

Patent • CNS Disorders • Narcolepsy • Sleep Disorder

[VIRTUAL] Vallon Pharmaceuticals (BIO 2021) - "The Company’s lead investigational product candidate, ADAIR (Abuse-Deterrent Amphetamine Immediate-Release), is a proprietary abuse-deterrent formulation of immediate release (IR) dextroamphetamine in development for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy. ADAIR is designed to deter attempts to crush and snort and provides barriers to injection."

ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Narcolepsy • Psychiatry • Sleep Disorder

Vallon Pharmaceuticals Reports First Quarter 2021 Financial Results and Provides Corporate Update (GlobeNewswire) - "ADAIR is the Company’s proprietary abuse-deterrent formulation of immediate-release dextroamphetamine currently in development for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy...The SEAL Study is expected to be the final clinical trial prior to NDA filing....Upcoming Milestones; Report pivotal data from the SEAL Study targeted for the second half of 2021. NDA submission targeted for the second quarter of 2022."

NDA • P1 data • Attention Deficit Hyperactivity Disorder • CNS Disorders • Narcolepsy • Sleep Disorder

Vallon Pharmaceuticals Continues Advancement of Pivotal Study in Lead Development Program, ADAIR, Toward Potential Approval (GlobeNewswire) - "Vallon Pharmaceuticals Inc....today provided a clinical program update for its lead program, ADAIR...'Through the use of the 505(b)(2) regulatory pathway, we expect to leverage much of the existing data for dextroamphetamine, which has been demonstrated to be an effective treatment for...narcolepsy'...'Remain on track with our expectations to report topline results in the second half of this year'...two cohorts of subjects have been screened, qualified, and completed the treatment phase of the study. Enrollment in the study remains ongoing. A total of 64 subjects demonstrating a confirmed positive response to stimulants are planned to enter the treatment phase."

Enrollment status • P1 data • Trial status • CNS Disorders • Narcolepsy • Sleep Disorder

SEAL: Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR) (clinicaltrials.gov) - P1; N=64; Recruiting; Sponsor: Vallon Pharmaceuticals, Inc.; Trial completion date: Jun 2021 ➔ Sep 2021; Trial primary completion date: Jun 2021 ➔ Sep 2021

Clinical • Trial completion date • Trial primary completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Narcolepsy • Psychiatry • Sleep Disorder

Vallon Pharmaceuticals Announces Presentation of ADAIR Pharmacokinetics and Pharmacodynamic Data at the Virtual 2021 APSARD Annual Meeting (GlobeNewswire) - P=NA, N=24; P1, N=16; ADAIR (NCT04232644); Sponsor: Vallon Pharmaceuticals, Inc.; "Vallon Pharmaceuticals Inc....today announced the presentation of pharmacokinetics (PK) and pharmacodynamic (PD) data from two studies evaluating...Abuse Deterrent Amphetamine Immediate Release (ADAIR), at the 2021 American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting which was held virtually January 15-17, 2021....The results presented from these two studies showed that ADAIR is bioequivalent to IR d-AMPH when administered orally, appears to be less desirable to recreational drug abusers when snorted compared to currently available IR dextroamphetamine, and support further investigation...in the treatment of ADHD and narcolepsy."

P1 data • PK/PD data • Attention Deficit Hyperactivity Disorder • CNS Disorders • Narcolepsy • Sleep Disorder

Data from Vallon Pharmaceuticals’ ADAIR Selected for Symposia Presentation at the Virtual 2021 APSARD Annual Meeting (GlobeNewswire) - "Vallon Pharmaceutical...today announced data from two studies evaluating its investigational new drug, Abuse Deterrent Amphetamine Immediate Release (ADAIR), have been selected for a symposia presentation at the virtual 2021 American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting being held January 15-17, 2021."

PK/PD data • CNS Disorders • Narcolepsy • Sleep Disorder

SEAL: Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR) (clinicaltrials.gov) - P1; N=64; Recruiting; Sponsor: Vallon Pharmaceuticals, Inc.

Clinical • New P1 trial • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Narcolepsy • Psychiatry • Sleep Disorder

Vallon Pharmaceuticals Presents Positive Data from Proof-of-Concept Intranasal Human Abuse Study of Its Investigational ADHD Stimulant, ADAIR (GlobeNewswire) - P=NA, N=16; "Vallon Pharmaceuticals Inc....today announced the presentation of positive data from a pilot study assessing human abuse liability for its investigational Abuse Deterrent Amphetamine Immediate Release (ADAIR) drug product....These data were recently presented by Dr. Timothy Whitaker in an oral presentation titled, 'Abuse-Deterrent Properties of a Novel Formulation of Immediate Release Dextroamphetamine (ADAIR) Compared to Reference Dextroamphetamine IR: Results from a Pilot Human Abuse Liability Study at the 2020 American Academy of Child & Adolescent Psychiatry (AACAP) Annual Meeting held October 12-24, 2020.'"

Clinical data • CNS Disorders • Narcolepsy • Sleep Disorder

[VIRTUAL] Abuse-Deterrent Properties of a Novel Formulation of Immediate-Release Dextroamphetamine Compared to Reference Dextroamphetamine Immediate-Release (AACAP 2020) - No abstract available

Vallon Pharmaceuticals presents positive data from pilot intranasal human abuse study of its investigational abuse deterrent stimulant, ADAIR, at the American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting (Businesswire) - P1, N=16; NCT04232644; Sponsor: Vallon Pharmaceuticals; "The results of this 16-subject trial (VAL-103) demonstrated that intranasal administration of manipulated ADAIR was generally well tolerated, with all adverse events considered mild or moderate, and no new safety or tolerability signals identified....'While we plan to consult with the FDA and conduct additional clinical trials, the data presented at APSARD, combined with market research feedback from physicians who treat ADHD and parents of teenagers and young adults who are prescribed ADHD stimulants, suggest that ADAIR, if approved, could be an important addition to available treatments for ADHD,' said..."

P1 data