PHILADELPHIA–(BUSINESS WIRE)–Vallon Pharmaceuticals Inc., a specialty pharmaceutical company focused on the development of novel drugs for CNS disorders, today announced the presentation of positive data from a pilot study assessing human abuse liability for its investigational Abuse Deterrent Amphetamine Immediate Release (ADAIR). The data were presented this weekend at the 2020 American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting in Washington, D.C. ADAIR, the Company’s lead investigational new drug, is in development for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy.
The poster, titled, “A Pilot Human Abuse Potential Study in Recreational Stimulant Drug Users Assessing Safety, Pharmacokinetics and Abuse Liability of Intranasally Administered Manipulated ADAIR and Dextroamphetamine Sulfate Tablets,” reported data from an intranasal (snorting) clinical trial of ADAIR, Vallon’s novel formulation of immediate release dextroamphetamine. 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. In this crossover comparative study, as compared to crushed and snorted dextroamphetamine sulfate, ADAIR demonstrated a blunted pharmacokinetic profile (lower Cmax, delayed Tmax, and lower AUC, especially during the early hours after administration). In addition, as compared to dextroamphetamine sulfate, even after extensive manipulation, ADAIR, when snorted, was less desirable to recreational drug abusers on key measures of abuse liability, in particular the Emax drug-liking scale (primary pharmacodynamic endpoint).
“Results from this pilot study suggest that Vallon’s investigational immediate release stimulant, ADAIR, may demonstrate less abuse potential than standard dextroamphetamine when manipulated and misused intranasally,” said Dr. Timothy Whitaker, a board-certified psychiatrist and Vallon’s Chief Medical Officer. “We appreciate the opportunity to present these findings to the attendees at APSARD, many of whom are at the forefront of ADHD research and patient care.”
According to reports from the US Department of Health and Human Services, more than 5 million Americans misuse or abuse prescription stimulants annually, most commonly teenagers and young adults. Separate studies report that approximately 40% of people who misuse prescription stimulants do so by snorting them.
“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 David Baker, President & Chief Executive Officer of Vallon.
ADAIR (Abuse Deterrent Amphetamine Immediate Release) is an investigational new drug; a novel, patented formulation of dextroamphetamine designed to deter attempts to crush and snort it or take it by other non-oral routes that can produce a greater “high.” Dextroamphetamine has been used clinically for more than fifty years. It is the same active ingredient used in FDA-approved products, such as Adderall®, Dexedrine®, and Vyvanse®. ADAIR is not approved by the FDA.
About Vallon Pharmaceuticals Inc.
Vallon Pharmaceuticals Inc. is a private, clinical-stage biopharmaceutical company, headquartered in Philadelphia, PA. The company is focused on the development of new medications to help patients with central nervous system (CNS) disorders. The company’s lead investigational product candidate is an abuse deterrent formulation of amphetamine immediate release (ADAIR) for the treatment of ADHD and narcolepsy. Vallon began conducting clinical trials of ADAIR in mid-2018. If clinical trials are successful, Vallon will seek marketing approval for the product from national regulatory bodies including the FDA. Vallon has raised more than $9 million in funding since its founding in 2018.
*Adderall, Dexedrine, and Vyvanse are registered trademarks of their respective companies.