Choose Novum’s Experience for Your Opioid Abuse Deterrent Studies Under the New Guidance
In November 2017, the FDA’s Center for Drug Evaluation and Research (CDER) released a new guidance entitled General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products. Although there may be applications pending at OGD, to-date there has not been a generic approval of a reference drug that has abuse-deterrent properties.
The guidance states the ANDA applicant must show its product’s abuse-deterrent properties are at least as effective (showing non-inferiority) as those of the RLD. For more information, please click here: https://www.fda.gov/downloads/Drugs/…/Guidances/UCM492172.pdf
Novum has years of experience conducting hundreds of controlled substance studies, and this new guidance plays to our strengths and capabilities in managing diverse and complex projects. We support clients in the design, conduct and analysis of the in vivo studies required by the new FDA Guidance for Evaluating the Abuse Deterrence of Generic Solid Opioid Drug Products.
The guidance recommends that data from both in vitro and in vivo studies be included in an ANDA submission. These studies can either be performed in the sponsor’s laboratory, or, if the sponsor does not have sufficient laboratory facilities, subcontracted to a qualified CRO. Novum has excellent relationships with qualified testing providers such as Sannova Analytical Inc. In addition to its in vivobioanalytical capabilities, Sannova has capabilities in conducting in vitro physiochemical analysis. It can assist in identification of the most effective manipulation conditions, for example, grating, milling, and/or cutting of the drug product unit. Using a combination of drug extraction into tiered solvent systems and physical manipulation of the drug product and as described in the guidance, Sannova performs analytical testing to evaluate the potential for abuse in routes involving syringability, insufflation and/or sublimation, etc., for test and reference formulations.
The in-vivo requirements can be supported by Novum – specifically the oral studies requiring the use of a manipulated product (chewing, milling, grating or cutting) – in a healthy, normal population under naltrexone blockade. Each study would be conducted as per protocol requirements (these may differ based upon approaches used during in-vitro testing).
The guidance also requires nasal insufflation PK studies that need to be conducted in recreational opioid users (not offered at Novum). Since the guidance release, Novum is actively working with a well-respected, experienced research partner in Pittsburgh to develop a solution for conducting these studies in volunteers who are recreational drug users. We will continue to provide details on this as we work to firm up our plans, but we intend to be able to support clients with all of these programs.
Please ask your client service or business development representative for more information on the guidance, Novum’s capabilities, or for an immediate discussion with Novum’s senior scientific and technical team regarding this topic.
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