Abuse-Deterrent, Amphetamine Immediate-Release (ADAIR) for ADHD

Alcobra is developing a proprietary Abuse-Deterrent Amphetamine Immediate-Release (ADAIR)  for ADHD. ADAIR is an oral formulation of immediate-release (short-acting) dextroamphetamine that is specifically designed to limit abuse by snorting or injecting. The U.S. Department of Health and Human Services reports that nearly two million people misuse or abuse prescription stimulants annually. The ADAIR formulation was developed in close collaboration with Capsugel®, an a global leader in delivering high-quality, innovative dosage forms and solutions.

Alcobra has filed patents protecting the ADAIR product drawing on discoveries made during the development process.

In 2015, nearly 25 million prescriptions were filled in the U.S. for IR stimulants, which represent the fastest growing class of prescribed ADHD drugs in both the pediatric and adult segments. While effective in the treatment of ADHD, CNS stimulants have been shown in multiple studies to have high potential for abuse and addiction and are scheduled as Class II controlled substances by the U.S. Drug Enforcement Agency (DEA) and other similar agencies outside the U.S.

The risks of stimulants are not limited to those who are prescribed the medications. Published studies report that between 25-60% of teenagers and college students with ADHD report being approached to give away or sell their medication. Other published studies report that 40% or more of the people who misuse stimulants, particularly immediate release stimulants, do so by snorting or injecting them.

Pediatric ADHD

Attention-deficit/hyperactivity disorder (ADHD) is the most common neurobehavioral disorder of childhood. According to the US Centers for Disease Control and Prevention (CDC) National Health & Nutrition survey (NHANES), about 9% of children in the US meet criteria for ADHD with similar numbers reported in other countries. Although boys are more commonly diagnosed, ADHD is also common in girls, who often go undiagnosed.

Inattention, hyperactivity, and impulsivity are the key behaviors of ADHD. It is normal for all children to be inattentive, hyperactive, or impulsive sometimes, but for children with ADHD, these behaviors are more severe and occur more often. To be diagnosed with the disorder, a child must have symptoms for 6 or more months to a degree that is greater than other children of the same age. These symptoms will interfere with the child's function in two or more settings, such as home and school.

In most cases, ADHD is best treated with a combination of medication and behavior therapy. Good treatment plans will include close monitoring with follow-up office visits to provide any changes needed along the way.

Research shows that behavioral therapy is an important part of treatment for children with ADHD. ADHD affects not only a child's ability to pay attention or sit still at school, it also affects relationships with family and how well they do in their classes. Behavioral therapy is a treatment option that can help reduce these problems for children and should be started as soon as a diagnosis is made.

Adult ADHD

Attention-deficit/hyperactivity disorder (ADHD) is a common and impairing neuropsychiatric condition. Once believed to only affect children, ADHD is now known to persist into adolescence and adulthood in the majority of cases. Approximately 4-5% of adults worldwide are affected with ADHD. Most adults with ADHD remain undiagnosed and untreated.

While approved stimulant medications have been shown to be effective and safe for the treatment of ADHD, stimulants have been shown to have high potential for abuse and addiction and are scheduled as Class II controlled substances by the U.S. Drug Enforcement Agency (DEA) and other similar agencies outside the U.S. Consequently, it is important to develop safe and effective  alternative formulations of stimulants to reduce risk of abuse.