– Survey results reinforce existing literature that immediate-release (IR) amphetamines, such as Adderall®, are the most commonly abused preparation of prescription stimulants
– Company’s abuse-deterrent stimulant formulations have the potential to address misuse and abuse of stimulant medication by non-oral routes, such as snorting
– Pivotal abuse study of the Company’s lead investigational program ADAIR completed enrollment and dosing with topline data expected this quarter
PHILADELPHIA, PA, Jan. 18, 2022 — 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 that new data from its recently-sponsored survey of stimulant abuse patterns in adults was presented at the APSARD 2022 Annual Conference, held virtually January 14-16, 2022.
David Baker, Chief Executive Officer of Vallon, commented, “With the misuse and abuse of prescription stimulants continuing to climb, the unmet need for abuse-deterrent formulations, and the potential of our platform technology, continues to grow. As we near the topline data readout for our lead program, ADAIR, we are pleased to report additional insights on the characteristics and behaviors of stimulant users, especially those who snort prescription stimulants. We look forward to reporting topline data from our pivotal SEAL study in the near term and, importantly, providing a potential solution to the help address the growing stimulant abuse problem.”
The poster titled, “Characteristics and Behaviors of Recreational Prescription Stimulant Users: Findings from an mTurk online survey,” outlined additional results from a large 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 (“MTurk”), an online crowdsourcing platform. A total of 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.
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.
“Among the more interesting findings of the survey were reports that people who snort prescription stimulants typically spend less than 10 minutes to prepare a stimulant for snorting, and if they were unable to manipulate a stimulant for snorting, very few claim they would escalate to a more serious route of abuse such as injecting or take a more harmful drug instead,” stated Timothy Whitaker, MD, Chief Medical Officer of Vallon. “ADAIR was developed to make it time consuming and difficult to prepare for non-oral routes, such as snorting or injecting.”
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.
- Prescription stimulant snorters were more likely than overall abusers to also report using other controlled substances including cannabis, cocaine, opioids, and methamphetamine.
- 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).
- More than 40% of respondents who snorted Adderall say their typical dose is up to 10 mg, 40% say 11-30 mg, and <5% report doses >30 mg.
- 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 prescription stimulants orally if unable to manipulate for snorting; <5% would try to prepare prescription stimulants to inject.
The APSARD 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