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Pipeline Overview

Advancing Abuse-Deterrent Formulations in Large Markets






505(b)(2) regulatory pathway anticipated


505(b)(2) regulatory pathway anticipated



Partnered with MEDICE






ADAIR: Abuse-Deterrent Formulation of Dextroamphetamine

ADAIR (proprietary abuse-deterrent formulation of immediate-release (IR) dextroamphetamine in development for the treatment of attention deficit hyperactivity disorder (ADHD) and narcolepsy. ADAIR is designed to deter attempts to crush and snort and provides barriers to injection.

Leveraging the clinical success of dextroamphetamine, we are developing ADAIR through a streamlined 505(b)(2) U.S. FDA regulatory pathway, which is expected to obviate the need for large Phase 2 and Phase 3 efficacy and safety studies. If approved, ADAIR is expected to be the first abuse-deterrent, immediate-release formulation of dextroamphetamine.


ADMIR: Abuse-Deterrent Formulation of Methylphenidate (Ritalin®)

We are advancing ADMIR, a novel abuse-deterrent formulation of immediate-release (IR) methylphenidate (Ritalin®). Ritalin is another commonly prescribed stimulant for treating ADHD which is frequently misused and abused. We are currently completing formulation development work for ADMIR and upon completion of that work we will seek approval to begin human clinical studies.


ADHD is the Most Common Neurobehavioral Disorder in Children

Attention-deficit/hyperactivity disorder (ADHD) is the most common neurobehavioral disorder of childhood. According to the U.S. Centers for Disease Control and Prevention (CDC) National Health & Nutrition Survey (NHANES), about 9% of children in the U.S. meet criteria for ADHD with similar numbers reported in other countries. 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.

While effective in the treatment of ADHD, stimulant medications 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 Administration (DEA) and other similar agencies outside the U.S.

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, friends/peers, 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.

Medications can affect children differently, where one child may respond well to one medication, but not to another. When determining the best treatment, a doctor might try different medications and doses, so it is important for parents to work with their child’s doctor to find the medication that works best for their child.

Market Share of Stimulant Medications

In 2019, over 20 million prescriptions were filled in the U.S. for immediate release (IR) stimulants such as Adderall® and Dexedrine®, which represent the fastest growing class of prescribed ADHD drugs.


Narcolepsy is a Chronic Sleep Disorder

Narcolepsy is a sleep disorder characterized by excessive sleepiness, sleep paralysis, and hallucinations. Narcolepsy occurs equally in men and women and is thought to affect roughly 1 in 2,000 people. The symptoms appear in childhood or adolescence, but many people have symptoms of narcolepsy for years before getting a proper diagnosis. Individuals with narcolepsy often feel very sleepy during the day and may involuntarily fall asleep during normal activities.

Stimulant medications such as Adderall and Dexedrine have been shown to be effective in treating narcolepsy symptoms.