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Vallon Pharmaceuticals Announces Topline Results of its Pivotal SEAL Study for Lead Program, ADAIR, for the Treatment of ADHD

Vallon Pharmaceuticals Announces Topline Results of its Pivotal SEAL Study for Lead Program, ADAIR, for the Treatment of ADHD

Vallon Prescribed drugs Inc.

Research did not satisfy key endpoint of considerable reduction in Emax Drug Liking for ADAIR vs reference dextroamphetamine, though a craze in favor of ADAIR was observed (p=.16)

All pharmacodynamic secondary endpoints fulfilled with statistical significance

Philadelphia, PA, March 21, 2022 (World NEWSWIRE) — Vallon Prescription drugs, Inc. (NASDAQ: VLON), (“Vallon” or the “Company”), a scientific-phase biopharmaceutical company largely focused on the improvement of novel drugs that are designed to prevent abuse in the cure of CNS diseases, these days introduced topline results from its pivotal SEAL analyze assessing ADAIR, a proprietary abuse-deterrent formulation of instant release (IR) dextroamphetamine for the cure of interest deficit hyperactivity condition (ADHD).

“First and foremost, I would like to lengthen our honest appreciation to our clinical team and CRO associates for their difficult work and commitment to execute the study, and to all of the analyze contributors. Though we are dissatisfied by the most important endpoint outcomes, lots of of the topline conclusions are encouraging and offer useful insight,” commented David Baker, President & Main Govt Officer of Vallon. “As we acquire more perception from even more assessment of all analyze endpoints, we will establish following methods for the enhancement plan, together with options to ask for a formal assembly with the Food and drug administration in the coming months and the prospective for an added study.”

The SEAL analyze (Study to Evaluate the Abuse Liability, Pharmacokinetics, Basic safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Fast Launch Formulation), is the Company’s pivotal intranasal human abuse liability review evaluating the pharmacodynamics (PD), pharmacokinetics (PK), security and tolerability of snorting professional laboratory-manipulated ADAIR 30 mg when in comparison to crushed d-amphetamine sulfate and placebo in leisure drug users. ADAIR was ready for snorting by a pharmacist making use of a multi-stage approach that experienced been formulated by a skilled laboratory and agreed on by the U.S. Foods and Drug Administration (Food and drug administration). The SEAL analyze enrolled 55 subjects, of whom 53 finished the examine and 52 ended up incorporated in the remaining assessment. The study involved a four-way crossover design and style to appraise professionally manipulated, intranasal ADAIR 30 mg, crushed intranasal dextroamphetamine, ADAIR 30 mg taken orally, and placebo. All topics had been non-dependent leisure stimulant users with an more heritage of recreational intranasal drug use.

The analyze did not meet up with its major endpoint, which was Emax Drug Liking. ADAIR scored likewise to what was noticed in an previously proof-of-strategy examine, even so, reference dextroamphetamine did not rating as higher as anticipated and as viewed in the past study, consequently driving the lack of statistical importance.

All pharmacodynamic secondary endpoints of the research ended up met with ADAIR scoring substantially reduce than reference dextroamphetamine on Overall Drug Liking assessed at 12 hrs (p<.0001) and 24 hours post-dosing (p=0.024). Willingness to Take Drug Again was also assessed at 12 hours (p<0.0001) and 24 hours post dosing (p<0.0001). Drug Liking was measured at twelve time points ranging from 15 minutes to 24 hours following dosing. A post-hoc analysis demonstrated that Mean Drug Liking for intranasal ADAIR was lower than reference dextroamphetamine at each time point from 15 minutes through 24 hours after dosing, reaching statistical significance for each time point from 15 minutes through 6 hours post-dosing.

Additionally, in the study ADAIR demonstrated higher scores on each of the 5 components on the Subject Rated Assessment of Intranasal Irritability (SRAII) suggesting that manipulated ADAIR was more irritating and less comfortable to snort than crushed dextroamphetamine, however, formal statistical analysis of the SRAII scale has not yet been completed.

Safety was assessed via adverse events, vital signs, ECGs, clinical laboratory tests and other standard measures. ADAIR was generally well tolerated, and the safety profile of all active treatment arms was consistent with the known effects of amphetamine, with no unexpected adverse events reported. There were no serious adverse events (SAEs) reported during the study in any treatment arm, and there were no discontinuations due to adverse events.

“Although the lower mean results for ADAIR on the primary endpoint did not reach statistical significance, the results of the pharmacodynamic secondary endpoints, Overall Drug Liking and Take Drug Again, were all statistically significant and encouraging,” added Dr. Timothy Whitaker, Chief Medical Officer of Vallon. “Beyond these topline results, additional calculation and analysis of other endpoints with our CRO partner will begin shortly including the pharmacokinetic results and results of other exploratory endpoints.”

For more information about the study, please visit clinicaltrials.gov and reference identifier: NCT04647903.

About ADAIR

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 50 years. It is the same active ingredient used in FDA-approved products, such as Adderall®, Dexedrine®, and Vyvanse®. ADAIR is not approved by the U.S. Food and Drug Administration (“FDA”).

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.

For more information about the company, please visit www.vallon-pharma.com or connect with us on LinkedIn or Twitter.

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, Vallon’s expectations related to results of clinical trials and studies, Vallon’s expectations with respect to the analysis of data and results from its pivotal SEAL study evaluating ADAIR, Vallon’s expectations with respect to the continued development of ADAIR, 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.

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