MedicalResearch.com Interview with:
Dr. Kenneth Koblan PhD
Sunovion Pharmaceuticals Inc.
Fort Lee, NJ and Marlborough, MA
Medical Research: What is the background for this study?
Dr. Koblan: Assessing abuse potential is important in the clinical development process for any therapy affecting the central nervous system, especially those that may act on dopamine and norepinephrine neurotransmitter systems. Human abuse liability studies are conducted to evaluate the abuse potential associated with drugs that affect the central nervous system.
Drugs that increase dopamine levels may be associated with stimulant effects and abuse (e.g., cocaine and amphetamine), whereas drugs that increase serotonin and/or norepinephrine levels are not generally associated with recreational abuse (e.g., selective serotonin reuptake inhibitors). Among drugs with effects on dopamine neurotransmission, slowing the rate of absorption is thought to reduce abuse potential, and increasing the rate of elimination is thought to reduce rewarding effects and abuse liability due to sustained elevations in drug concentrations resulting in sustained inhibition of dopamine transporters (DAT).
Dasotraline is an investigational dopamine and norepinephrine reuptake inhibitor from Sunovion in late-stage development to evaluate its use in treating the symptoms of attention deficit hyperactivity disorder (ADHD) and binge-eating disorder (BED). Dasotraline has slow absorption and elimination that supports the potential for plasma concentrations yielding a continuous therapeutic effect over the 24-hour dosing interval at steady state.
Medical Research: What are the main findings?
Dr. Koblan: The data showed that dasotraline single doses of 8 mg, 16 mg and 36 mg were not significantly different compared to placebo on the primary endpoint and most secondary endpoints (all of which assessed the potential for abuse) and were associated with significantly lower drug liking compared to 40 mg and 80 mg single doses of methylphenidate.
Medical Research: What should clinicians and patients take away from your report?
Dr. Koblan: Dasotraline was discovered by Sunovion Pharmaceuticals Inc. and is currently in development to evaluate its use in treating the symptoms of ADHD in adults and children and the symptoms of BED in adults. It has not been approved by the U.S. Food and Drug Administration (FDA) for the treatment of ADHD, BED, or any other disorder. We are encouraged by these study findings and look forward to sharing future results from our comprehensive clinical trial program.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Koblan: The results of the current study suggest that there is a potential therapeutic role for medications with a pharmacologic profile that combine both DAT and norepinephrine transporter (NET) inhibition, but without the abuse liability associated with drugs that increase dopamine levels.
Medical Research: Is there anything else you would like to add?
Dr. Koblan: Sunovion is engaged in a full clinical development program to evaluate the use of dasotraline in the treatment of adults and pediatric patients with attention deficit hyperactivity disorder and in the treatment of adults with binge-eating disorder.
Dr. Kenneth Koblan PhD (2016). Dasotraline Explored For Treatment of ADHD and Binge Eating Disorders