Opioids - Where are we now?
Back in 2009, the FDA began meeting with companies regarding Long-Acting/Extended Release Opioids. The purpose of these meetings was to begin to address the problem of Opioid abuse through diversion in the United States. Why this is important for companies in general is because it can help influence *how* you approach developing these kinds of products.
The first thing to consider is the current trend toward tamper resistant products. Depending on what kind of product you are looking at, this can be accomplished either with the formulation of your product, or through a delivery system, such as a device which can control how often a product is administered or is tamper resistant. Your Regulatory group can help advise you on which path might be best for your product. In addition, they can help you consider what kind of REMS you will be looking at for these kinds of products. It is pretty much a guarantee that you will be given a REMS program with these kinds of products, but Regulatory can help guide your hand in this process.
One piece of advice is to find a Regulatory consultant with experience in this area. Someone who understands the safety and pharmacovigilence aspects of Regulatory and how it relates to Clinical, Manufacturing, and Marketing. This is especially important with the Elements to Assure Safe Use (ETASU) portions of REMS plans. Again this is an area where good Regulatory leadership and experience can give you not only a large benefit, but also a competative advantage.
