– Results suggest that developing stimulant formulations with abuse deterrent properties by non-oral routes may potentially reduce negative consequences of misuse, abuse, and diversion of stimulant medication
– Company’s lead investigational program ADAIR, a novel abuse-deterrent formulation of immediate-release dextroamphetamine in development for the treatment of ADHD, advancing toward completion of patient enrollment and treatment in pivotal SEAL study
PHILADELPHIA, PA, Nov. 01, 2021 — Vallon Pharmaceuticals, Inc. (NASDAQ: VLON), (“Vallon” or the “Company”), a clinical-stage biopharmaceutical company primarily focused on the development of novel drugs that are designed to deter abuse in the treatment of central nervous system (CNS) disorders, today announced data from its recently sponsored survey of stimulant abuse patterns in adults was presented at the AACAP 68th Annual Meeting held virtually October 18-30, 2021.
David Baker, Chief Executive Officer of Vallon commented, “The results from this survey were very insightful and bolstered our belief in the need for abuse-deterrent stimulant formulations. The findings were consistent with existing literature that immediate release (IR) amphetamines are the most commonly abused type of prescription stimulants. The results also provide quantitative data indicating that those who manipulate stimulants for snorting report typically spending only 5-10 minutes tampering and, importantly, indicating that very few would escalate to injecting or shifting to other drugs of abuse if they were unable to manipulate a stimulant for snorting. We believe our abuse-deterrent platform has the potential to positively impact the frequency of stimulant abuse and potentially slow the rapidly growing stimulant abuse activity amongst adults.”
The poster titled, “Characteristics and Behaviors of Recreational Prescription Stimulant Users: Findings from an mTurk online survey,” was presented by Timothy Whitaker, MD, Chief Medical Officer of Vallon Pharmaceuticals. The presented data outlined results from a recently sponsored survey, led by researchers at the University of Kentucky, of nearly 500 people who misuse or abuse prescription stimulants. Participants in the survey were recruited using Amazon.com Mechanical Turk, an online crowdsourcing platform. 975 respondents aged 18 – 30 completed the survey between March – April 2020, of whom 496 reported using a prescription stimulant when not prescribed to them. The survey included demographic and drug use questionnaires, as well as clinical and behavioral instruments.
“While effective in the treatment of ADHD, CNS stimulants have been shown in multiple studies to have a high risk for abuse, with approximately 40% or more of the people who misuse or abuse stimulants doing so by snorting or injecting them. There is a growing concern with prescription stimulant abuse and an unmet need for abuse-deterrent formulations,” added Dr. Whitaker. “We are pleased with the progress we have made with our lead development program, ADAIR, and look forward to potentially bringing to market the first abuse-deterrent formulation of an immediate release amphetamine-based product.”
The survey was conducted through a common online platform, MTurk, which has been used in addiction science research to efficiently crowd source information from large populations.
Summary of Results
- A total of 496 responders who were surveyed reported using a prescription stimulant when not prescribed; >150 admitted snorting prescription stimulants.
- While most abusers reported taking prescription stimulants orally, 32% reported snorting, 2% injecting, and 4% vaping.
- Almost 90% of prescription stimulant snorters have done so with an IR amphetamine.
- Adderall (mixed amphetamine salts immediate release) was the most commonly snorted prescription stimulant (n=135).
- Over 80% of those who snort say it takes no more than 5 minutes to manipulate; Over 90% say it takes no more than 10 minutes.
- Over 90% of snorters say they would take the stimulant orally if unable to manipulate for snorting; <5% would try to prepare the stimulant to inject.
The AACAP poster presentation can be accessed on the Publications page of the Company’s website.
About Vallon Pharmaceuticals, Inc.
Vallon Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company, headquartered in Philadelphia, PA. The Company is focused on the development of new medications to help patients with CNS disorders. The Company’s lead investigational product candidate, ADAIR, is a novel abuse-deterrent formulation of amphetamine immediate release being developed for the treatment of ADHD and narcolepsy.
References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Vallon is not responsible for the contents of third-party websites.
Forward Looking Statements
This press release contains “forward-looking statements” that are based on Vallon’s current expectations and subject to inherent uncertainties, risks and assumptions that are difficult to predict, including, without limitation, Vallon’s ability to execute its business plan, continue its growth and fund its ongoing business activities as planned, Vallon’s ability to develop and commercialize its product candidates, expectations related to results of clinical trials and studies, Vallon’s expectations with respect to the important advantages it believes its abuse-deterrent formulation of drugs have over similar drugs in the market and the growing need for abuse-deterrent formulations of drugs, Vallon’s ability to utilize the 505(b)(2) regulatory pathway, Vallon’s ability to obtain FDA approval of ADAIR and its other product candidates, and Vallon’s expectations with respect to its cash runway. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in Vallon’s Quarterly and Annual Reports filed with the U.S. Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.
JTC Team, LLC