Vallon Pharmaceuticals Reports Additional Pharmacokinetic & Pharmacodynamic Data From SEAL Study of ADAIR

Vallon Pharmaceuticals, Inc. recently reported additional results from the SEAL study evaluating the abuse potential of ADAIR. 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.

In March 2022, the company reported topline results from its SEAL study (Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation). The SEAL study was the company’s pivotal intranasal human abuse liability study assessing the pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of snorting professional laboratory-manipulated ADAIR 30 mg when compared to crushed d-amphetamine sulfate and placebo in recreational drug users. ADAIR was prepared for snorting by a pharmacist using a multi-step technique that had been developed by a professional laboratory and agreed upon by the US FDA. The SEAL study enrolled 55 subjects, of whom 53 completed the study and 52 were included in the final analysis. The study involved a four-way crossover design to evaluate professionally manipulated, intranasal ADAIR 30 mg, crushed intranasal dextroamphetamine, ADAIR 30 mg taken orally, and placebo. All subjects were non-dependent recreational stimulant users with an additional history of recreational intranasal drug use.

Summary of Additional Data from the SEAL Study

• Vallon has completed its initial analysis of the full data set and has received final tables, figures, and listings for the study.
• Pharmacokinetic analysis showed that professionally manipulated ADAIR taken intranasally demonstrated a blunted pharmacokinetic profile compared to crushed and snorted dextroamphetamine including lower maximum blood levels of dextroamphetamine (C_max), a longer time to maximum blood concentrations (T_max), and lower overall drug exposure (AUC) especially during the early time points up to 1, 2, and 4 hours after dosing.
• As previously reported, secondary endpoints of Overall Drug Liking and willingness to Take Drug Again at 12 and 24 hours post-dosing were all statistically significantly lower for manipulated ADAIR taken intranasally compared to crushed and snorted reference dextroamphetamine. On the additional endpoints of E_max Overall Drug Liking and E_max Take Drug Again, ADAIR was also statistically significantly lower than reference dextroamphetamine.
• As previously reported, ADAIR intranasal (IN) 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. The additional analysis confirms that all of those differences were statistically significant.
• On the pharmacodynamic endpoint of “Feeling High” ADAIR IN was significantly lower than reference Dextroamphetamine IN.
• On the endpoint of “Good Effects,” there was a strong trend towards lower scores with ADAIR IN (p=0.0513); there were no significant differences on the endpoint of “Bad Effects.”
• The overall safety and tolerability profile of ADAIR in the SEAL study was consistent with the well-established profile of dextroamphetamine. 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.

As previously reported, the SEAL study did not meet its primary endpoint, which was E_max Drug Liking. ADAIR scored similarly to what was observed in an earlier proof-of-concept study, however, reference dextroamphetamine did not score as high as expected and as seen in the previous study, thus driving the lack of statistical significance.

“While we were disappointed we did not meet our primary endpoint for the SEAL study, we are encouraged by the additional results found upon further analysis of the data that show favorable outcomes on additional secondary and exploratory pharmacokinetic and pharmacodynamic endpoints,” said David Baker, President & CEO of Vallon. “We are continuing to work with our advisors and partners to assess the full data set from the SEAL study and to evaluate next steps and a potential path forward for the ADAIR development program.”

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

In April 2022, Vallon commenced a review of strategic alternatives for the company, which could include, without limitation, exploring the potential for a possible merger, business combination, investment into the company, or a purchase, license or other acquisition of assets. The company is continuing to assess the best path forward for ADAIR and for ADMIR. In the meantime, and in conjunction with the exploration of strategic alternatives, the Company is streamlining its operations in order to preserve its capital and cash resources.

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 US FDA.

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.

The company recently announced it is evaluating strategic alternatives with the goal of maximizing shareholder value, which could include, without limitation, exploring the potential for a possible merger, business combination, investment into the Company, or a purchase, license or other acquisition of assets. This process may not result in any transaction and the Company does not intend to disclose additional details unless and until it has entered into a specific transaction. For more information, visit www.vallon-pharma.com.