Sunday, April 18, 2021 7:41:51 PM
- 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.
Recent VLON News
- Form 8-K - Current report • Edgar (US Regulatory) • 04/01/2024 01:13:53 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 03/28/2024 08:45:04 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 03/28/2024 08:42:12 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 02/02/2024 09:25:45 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/02/2024 09:23:00 PM
- Form 424B4 - Prospectus [Rule 424(b)(4)] • Edgar (US Regulatory) • 02/02/2024 09:21:50 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 02/02/2024 05:15:17 AM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 01/30/2024 01:13:21 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/30/2024 01:12:42 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 01/19/2024 09:16:24 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/19/2024 09:15:15 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/16/2024 01:45:50 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 12/20/2023 10:12:21 PM
- Form 424B3 - Prospectus [Rule 424(b)(3)] • Edgar (US Regulatory) • 12/15/2023 10:02:30 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/05/2023 02:07:52 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/27/2023 01:38:43 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/24/2023 09:04:14 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/15/2023 01:07:13 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 11/01/2023 12:45:57 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 10/13/2023 08:40:34 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/25/2023 08:42:52 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/23/2023 01:07:49 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/14/2023 08:06:20 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2023 12:08:45 PM
FEATURED Cannabix Technologies Launches New Compact Breath Logix Workplace Series and Prepares for Delivery to South Africa • May 7, 2024 8:51 AM
Moon Equity Holdings, Corp. Announces Acquisition of Wikolo, Inc. • MONI • May 7, 2024 9:48 AM
NanoViricides Reports that the Phase I NV-387 Clinical Trial is Completed Successfully and Data Lock is Expected Soon • NNVC • May 2, 2024 10:07 AM
ILUS Files Form 10-K and Provides Shareholder Update • ILUS • May 2, 2024 8:52 AM
Avant Technologies Names New CEO Following Acquisition of Healthcare Technology and Data Integration Firm • AVAI • May 2, 2024 8:00 AM
Bantec Engaged in a Letter of Intent to Acquire a Small New Jersey Based Manufacturing Company • BANT • May 1, 2024 10:00 AM