Abuse-Deterrent Formulation Technology

Striving to Improve Outcomes for At-Risk Individuals

Stimulant Abuse

Prescription Stimulant Abuse is a Large and Growing Concern

Over 5 million adolescents and adults misuse prescription stimulant medications on an annual basis, according to the U.S. Department of Health and Human Services’ 2018 National Survey on Drug Use and Health (NSDUH). Even more worrisome, multiple studies of college students and people entering addiction treatment centers report that 40% or more of people who misuse prescription stimulants do so by snorting or injecting these products.

The risks of stimulants are not limited to those who are prescribed the medications. Published studies report that nearly 25% of teenagers with ADHD report being approached to give away or sell their stimulant medication. More than 60% of college students with ADHD admit that they have diverted (sold or given away) their prescription stimulant medication.

Video courtesy of Abuse Deterrent Coalition

5+ million

adolescents and adults misuse prescription stimulants annually1

From 2004 – 2011, emergency department visits due to non-medical use of stimulants2

Increased 4.7x

Increased 5x

From 2010 – 2017, deaths associated with prescription stimulants3

Stimulant Abuse Can Cause Serious Adverse Events

The medical risks associated with misusing and abusing stimulants are substantial, particularly when snorted or injected which allows for rapid entry of the drug into the bloodstream. These risks include irregular heartbeat, heart attack, seizures, hallucinations, hostile behavior, and stroke.

Sources: 1. SAMHSA, Center for Behavioral Health Statistics and Quality, National Survey on Drug Use and Health, 2018; 2. Drug Abuse Warning Network, 2011; 3. Black, CPDD, 2020; 4. White et al, Jrnl of Amer Coll Health 2006; 5. Cassidy et al, Jrnl Attention Disorders, 2013.

How it Works

Our Technology is Designed to Resist Manipulation for Snorting and Provide Barriers to Injection

Our lead investigational product candidate, ADAIR (Abuse-Deterrent Amphetamine Immediate-Release), is a proprietary abuse-deterrent formulation of immediate release (IR) dextroamphetamine designed to deter attempts to crush and snort and to provide barriers to injection.

Resists Efforts to Snort or Inject

Clinical Data

In a Bioequivalence Study,

ADAIR Behaved Like Traditional ADHD Product When Taken Orally

ADAIR and non-ADF Dexamphetamine Pharmacokinetics

Single center, randomized, single-dose, laboratory‑blinded, 2‑period, 2‑sequence, crossover design in 24 healthy subjects.

In a Human Abuse Liability Study,

Recreational Drug Users Liked ADAIR Less

Abuse Liability Parameters

Results from Proof-of-Concept Intranasal Abuse Study evaluating the safety, pharmacokinetics (PK), and abuse liability of manipulated ADAIR to crushed IR dexamphetamine tablets administered intranasally.

Publications

Posters and Publications

ADAIR: An Abuse-Deterrent Oral Formulation of Immediate Release Dextro-Amphetamine Sulfate (d-amphetamine)
Abuse-Deterrent Properties of a Novel Formulation of Immediate-Release Dextroamphetamine (ADAIR) Compared to Reference Dextroamphetamine IR
In-vitro and In-vivo Assessment of a Novel Immediate Release Abuse Deterrent Dextroamphetamine Formulation
Understanding Abuse Risk Related to Immediate-Release Amphetamine

Scientific publications discuss investigational uses of ADAIR.