Challenges in Medication Development for Addictions

Addictions are common, debilitating and costly disorders. Addictive disorders are chronic conditions characterized by compulsive use despite medical and psychological consequences of addiction. Interrupting drug use is associated with withdrawal and craving which are alleviated by using the drug again.

Multiple medications have been studied for the treatment of addictions but only few have been shown to be efficacious in well-controlled studies. Medications that have been approved by FDA target opioid, alcohol and nicotine addiction while no approved medications are available for cocaine or benzodiazepine addiction. Only fraction of patients receive medication assisted therapies even when an approved medication is available for treatment.

Developing new medications for addictions has many challenges. For cocaine and benzodiazepine dependence, regulatory authorities have not yet provided guidance as to what level of reduction in use constitutes clinically meaningful change, or whether the trials should be designed to test whether a complete abstinence can be achieved. From a clinical trial conduct perspective, one challenge is patient compliance during the trial. In a recent trial for cocaine dependence, only 40-60% of patients were estimated to be compliant with the study medication (Somoza et al JAMA Psychiatry 70: 630-637, 2013). Frequent engagement with patients and electronic patient reminders may be ways to enhance compliance and subject retention. Another challenge from operational perspective is to ensure that clinical trial end-points which rely on patient recollection of use, such as the time-line followback, are collected uniformly across the investigative sites. For these types of end-points, training and certification of the principal investigators is very important.

Dr. Lappalainen will present an overview of what medications have been developed for addictive disorder, what study end-points were used, and what operational challenges companies may face when developing medications for addictive disorders.

Speaker

Jaakko Lappalainen, MD, PhD, Executive Director, Global Drug Development, Neuroscience at Premier Research

Dr. Jaakko Lappalainen, MD, PhD is a board certified psychiatrist with long experience in neuroscience research and clinical treatment of psychiatric disorders and addictions. He graduated from University of Turku (Finland), completed his post-doctoral training at National Institutes of Health (NIH/NIAAA) and residency at Yale University. Following graduation he became Assistant Professor at Yale University. Dr Lappalainen held clinical appointments at the West Haven VA Medical Center between 2001-2006. In 2006 he joined AstraZeneca where he specialized in the design, execution and interpretation of clinical trials across Phase I-III development in the CNS therapeutic area. Between 2010-2014 Dr. Lappalainen was the lead physician for Phase 3 development of naloxegol (Movantik®) and played a key role in the regulatory submission of naloxegol in US, Europe and Canada. Dr. Lappalainen has been a recipient of many research and clinical awards and authored or co-authored over 60 scientific original publications.

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