SOURCE: Xtalks

Xtalks Webinars

October 16, 2015 06:30 ET

Webinar to Examine Challenges in Medication Development for Addictions

TORONTO, ON--(Marketwired - October 16, 2015) - On Wednesday, October 28, 2015, Premier Research will feature a live webinar on what medications have been developed for addictions, what study end-points were used, and what operational challenges companies may face when developing medications for addictions. The keynote speaker for this one-hour live session will be Dr. Jaakko Lappalainen, Executive Director, Global Drug Development, Neuroscience at Premier Research.

Addictions are common, debilitating and costly disorders. Addictions 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.

For more information about this event (hosted by Xtalks) or to register visit: Challenges in Medication Development for Addictions

About Premier Research

Premier Research is a leading contract research organization serving the needs of biotechnology, pharmaceutical, and medical device companies worldwide. The company has a wealth of experience in the execution of global, regional, and local clinical development programs, with a special focus on addressing unmet needs in areas such as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research. Premier Research operates in 50 countries and employs more than 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. With its mission to improve productivity in clinical development, the company aligns itself with the mission of its customers to bring new medical treatments to patients promptly, accurately, and cost-effectively.

To learn more about Premier Research visit:

About Xtalks

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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