Vallon Pharmaceuticals Continues Advancement of Pivotal Study in Lead Development Program, ADAIR, Toward Potential Approval
- Ongoing ADAIR SEAL study on target for pivotal data readout in second half of 2021.
- Target NDA filing in Q2 2022 for a potential abuse-deterrent alternative to commercially available IR amphetamines in the treatment of ADHD, a ~$9 billion U.S. market.
PHILADELPHIA, PA, April 13, 2021 (GLOBE NEWSWIRE) -- 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 CNS disorders, today provided a clinical program update for its lead program, ADAIR, a proprietary abuse-deterrent formulation of immediate-release (IR) dextroamphetamine currently in development for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy.
“Prescription stimulant abuse is a growing, serious issue with more than five million Americans misusing and abusing ADHD prescriptions stimulants on an annual basis. We believe ADAIR, if approved, has the potential to help address this significant problem by making it difficult for individuals to manipulate the drug. Our proprietary immediate release formulation has been shown in studies to behave as intended when taken orally, but is difficult to prepare for snorting or injecting,” commented David Baker, President & Chief Executive Officer of Vallon.
Vallon is currently conducting its pivotal intranasal human abuse liability study, which is expected to be the final clinical trial prior to NDA filing. This ongoing SEAL study (Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation), is a pivotal randomized, double-blind, double dummy, placebo and active-controlled 4-period, 4-way crossover assessing the abuse potential of ADAIR compared to dextroamphetamine administered intranasally in recreational drug abusers with past history of snorting stimulants.
“Through the use of the 505(b)(2) regulatory pathway, we expect to leverage much of the existing data for dextroamphetamine, which has been demonstrated to be an effective treatment for ADHD and narcolepsy,” added Dr. Timothy Whitaker, Vallon’s Chief Medical Officer. “Our ongoing SEAL study is designed to evaluate the safety and abuse liability of ADAIR by recreational drug users. We are pleased with the progress of the study and remain on track with our expectations to report topline results in the second half of this year, which have the potential to support our NDA filing in the second quarter of 2022.”
The SEAL study will assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability of manipulated ADAIR 30mg when compared to crushed d-amphetamine sulfate and placebo. The primary PD endpoint is mean maximum (Emax) Drug Liking on a bipolar 100mm visual analog scale, a standard endpoint used in human abuse liability studies.
To date, two cohorts of subjects have been screened, qualified, and completed the treatment phase of the study. Enrollment in the study remains ongoing. A total of 64 subjects demonstrating a confirmed positive response to stimulants are planned to enter the treatment phase. Safety will be assessed via adverse events, vital signs, ECGs, clinical laboratory tests and Columbia Suicide Severity Rating Scale (C-SSRS).
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 FDA.
ADAIR is also being developed for Europe and the UK through a license and collaboration agreement with MEDICE Arzneimittel Pütter GmbH, a leader in the European ADHD market.
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