Vallon Pharmaceuticals, Inc. announced the presentation of pharmacokinetics (PK) and pharmacodynamic (PD) data from two studies evaluating its investigational new drug, Abuse Deterrent Amphetamine Immediate Release. Rapid absorption and higher peak concentrations of stimulants from both intranasal (IN) and intravenous (IV) use are especially concerning due to higher adverse events and abuse liability compared to oral routes. ADAIR is a novel oral formulation of IR (immediate release) dextroamphetamine that is specifically designed to limit abuse by snorting or injecting, currently under development for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy. The results presented included data from two completed studies. The first study enrolled 24 subjects and was designed to compare the PK of d-AMPH from ADAIR 10 mg to IR d-AMPH 10 mg administered orally. The geometric LS means and the 90% confidence intervals of Cmax, AUC0-t and AUC0-8 all met predefined acceptance criteria, thereby demonstrating bioequivalence between the ADAIR and d-AMPH. The second study was designed to assess the safety, PK, and PD of manipulated ADAIR 30 mg compared to crushed IR d-AMPH 30 mg administered intranasally (snorted) in non-dependent recreational stimulant users. The primary PD endpoint was mean maximum drug liking (Emax) on a visual analog scale (VAS). Thirty-two subjects entered the qualification phase, and 16 qualified subjects (e.g., ability to discriminate stimulants) entered and completed the treatment phase. Safety was assessed via adverse events, vital signs, ECGs, safety labs and ratings of suicidality. The primary PD endpoint demonstrated manipulated intranasal ADAIR had significant reduction in drug liking (p<0.0001) compared with intranasal d-AMPH. Similarly, good drug effects were also lower for manipulated intranasal ADAIR (p=0.0016). Manipulated intranasal ADAIR demonstrated more negative effects particularly on the SRAII (Subject-Rated Assessment of Nasal Irritation) scale (e.g., nasal burning, discharge, and congestion) compared to intranasal d-AMPH (p’s<0.05). All other PD endpoints reflected abuse-deterrent properties for intranasal ADAIR relative to intranasal d-AMPH (e.g., Take Drug Again, High, Subjective Drug Value). The safety profile of ADAIR in each of the two studies was consistent with known adverse effects of stimulants with no new safety or tolerability signals identified. The results presented from these two studies showed that ADAIR is bioequivalent to IR d-AMPH when administered orally, appears to be less desirable to recreational drug abusers when snorted compared to currently available IR dextroamphetamine, and support further investigation of ADAIR as a potential, abuse-deterrent IR alternative in the treatment of ADHD and narcolepsy.