Abuse-Deterrent Studies – An Interview with Angela Moore

What is Alcami’s approach when preparing for an abuse deterrence study?
Alcami has full GMP traceability; some other places that are also performing these experiments haven’t even been inspected by the FDA. Alcami also has vast experience in this area with a very good understanding of different types of manipulation techniques that can be used. This is critical since manipulation is one of the most important parts of in vitro abuse-deterrent testing.

Alcami also has a good idea of how much time it takes to abuse a product and what the FDA is looking for in these cases. For example, if a tablet can be ground down into really tiny pieces, but it takes an hour to complete this, that’s probably not going to be a common route of abuse in a real-world experience.

Alcami also uses a team-based approach when applying appropriate resources to effectively utilize and meet client deadlines. This is especially important as Category 1 strategies and results drive the in-vivo Category 2 and 3 studies required for abuse-deterrent labeling of drug products.

How does Alcami’s abuse-deterrent studies help combat the national opioid crisis and how has working on abuse-deterrents affected your views on the epidemic?
I think everybody is affected in some way, shape or form. I have former classmates who have either overdosed or have been affected by opioids first-hand. Working on abuse-deterrent testing gives me hope because it gives a view of the behind the scenes innovations and the effort that pharmaceutical companies are putting forth to help combat this horrible epidemic that is facing our world. Alcami has patients in mind when working to help solve this problem through formulations.

Thanks for all of your insight, Angela. To conclude, let’s do a lightning Q & A round, if that is okay with you?
Fire away!

1. What’s a typical timeline for testing?
   That’s totally dependent on the scope of the project and the client needs, however, Alcami has been able to meet aggressive timelines in the past through team-based approaches to testing.

2. Has Alcami worked on products that have been approved by the FDA before?
   Yes, we’ve worked on multiple cases that have been approved by the FDA.

3. What things does the FDA look for in a successful filing for this type of study?
   One of the most important aspects of Category 1 testing is study design and repeatability. Multiple replicates give confidence in results. Also, a well-thought-out design of experiments and testing to failure is key for these studies. Exact study requirements are not clearly defined through current guidance and the FDA uses a “totality of evidence” approach when evaluating these formulations.

5. Do you recommend moving forward with studies prior to FDA reviewing protocols?
   This is entirely dependent on timelines. However, Alcami recommends to at least engage in conversations with the FDA about testing protocols, as requirements change and every formulations is different.
6. What types of studies are performed within abuse deterrence?
   The typical studies mimic real-world abuse of the opioid in question. Some main examples are: physical manipulation evaluations, large volume extractions, syringeability testing, smoking studies, liquid-liquid and free-base extractions, and if needed, isolation of opioid/antagonist studies. Alcami can also build a customizable project that suits the clients’ needs.
   
   

Technical Contributor 
Angela Moore, M.Sc. has over 12 years of experience performing analytical testing in the pharmaceutical industry for both branded and generic products and their active pharmaceutical ingredients. She has considerable experience successfully executing several FDA Category 1 in vitro abuse-deterrent studies on drug products that are designed to help combat opioid abuse. She also performs development and validation studies for API and Drug Products, generates technical test protocols and reports, and is the subject matter expert for the company in abuse-deterrent products and testing. Angela holds both Master of Science and Bachelor of Science degrees in Chemistry from East Carolina University.