- ADAIR demonstrated bioequivalence to immediate release (IR) d-AMPH when administered orally and appears to be less desirable to recreational drug abusers when snorted compared to currently available IR dextroamphetamine
- ADAIR to enter pivotal intranasal abuse study to support future NDA filing as an alternative to commercially available IR amphetamines in the treatment of ADHD and Narcolepsy
PHILADELPHIA, PA (GLOBE NEWSWIRE) — Vallon Pharmaceuticals Inc., (“Vallon” or the “Company”), a biopharmaceutical company focused on the development of novel drugs for CNS disorders, today announced the presentation of pharmacokinetics (PK) and pharmacodynamic (PD) data from two studies evaluating its investigational new drug, Abuse Deterrent Amphetamine Immediate Release (ADAIR), at the 2021 American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting which was held virtually January 15-17, 2021.
The presentation titled, Pharmacokinetic and Pharmacodynamic Studies of an Abuse Deterrent Formulation of Dextroamphetamine was delivered on Friday, January 15th in the Novel Pharmacology and Technology Approaches to the Non-Medical Use of Stimulants symposia by Timothy Wilens, M.D., chief of the Division of Child and Adolescent Psychiatry and is co-director of the Center for Addiction Medicine at Massachusetts General Hospital.
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.
“There remains a clear unmet need for products that can treat ADHD effectively while attending to the significant problem of stimulant misuse. The results from these two early studies are encouraging for continued evaluation of ADAIR and its potential to address stimulant misuse that is problematic with currently available immediate release amphetamines,” commented Dr. Wilens.
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-? 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.
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 fifty years. It is the same active ingredient used in FDA-approved products, such as Adderall®, Dexedrine®, and Vyvanse®. ADAIR is not approved by the FDA.
About Vallon Pharmaceuticals Inc.
Vallon Pharmaceuticals Inc. is a private, clinical-stage biopharmaceutical company, headquartered in Philadelphia, PA. The Company is focused on the development of new medications to help patients with central nervous system (CNS) disorders. The Company’s lead investigational product candidate, ADAIR, is a novel formulation of amphetamine immediate release being developed for the treatment of ADHD and narcolepsy.
*Adderall, Dexedrine, and Vyvanse are registered trademarks of their respective companies.
JTC Team, LLC