Abuse Deterrent Technology Comes of Age in Opioid Formulation
[Posted on: Thursday, August 6, 2015] [By Dr. Wanyoike Kang'ethe]

The death toll from prescription opioids abuse has been soaring around the world over the past 20 years. It now exceeds fatalities from road accidents or deaths from heroin and cocaine in the United States, the United Kingdom and Australia according to a recent article in Nature magazine. As discussed in the article, some of the more promising approaches in the long running fight against painkiller abuse and addiction utilize ingenious pill formulations and sophisticated manufacturing technologies to render the drugs less prone to misuse, yet work as intended when taken as directed. Examples include tablet formulations so hard that a hammer-blow cannot pulverize them, or pills that form a gummy substance when combined with water making it very difficult to draw into a syringe for injection. Other formulations are prodrugs that require metabolic activity to turn into the active substance, or contain reversal agents that counteract the desired euphoria when misused. Although misuse is still possible, the built in barriers can be significant enough to deter the majority of intended abuse. Earlier in April, the FDA released a final guidance on abuse deterrence for industry. The rule requires that manufacturers conduct scientifically rigorous tests to demonstrate to regulators that features intended to deter opioid abuse actually accomplish that goal, prior to making any labeling claims. While the guidance does not require proof of deterrence as a condition for marketing approval, FDA expects companies to update their formulations to take advantage of technological advances in this area. As an incentive, a new product that is shown to deter abuse may be eligible for an extended period of marketing exclusivity. Already, there are companies that are seizing this opportunity. On September 11, for instance, two FDA advisory panels are scheduled to review an oxycodone extended-release capsule formulation for management of severe pain requiring daily, around-the-clock, long-term opioid treatment that is designed to resist the manipulation necessary to allow abuse or misuse by the four common routes of administration, i.e. orally, snorting, smoking, and injecting. Still, these technologies are not cheap and their benefits will likely only be realized if authorities require drug companies to include them, especially in competing generic painkillers. In seeming concurrence, the FDA has indicated that it is working on guidance that will support the development of abuse-deterrent generic opioid products while also ensuring patient access to effective pain medication.