Deaths from unintentional overdoses of prescription drugs have reached epidemic proportions in the US, outnumbering deaths from motor vehicle crashes or suicides in 20 states. Approximately 27,500 people died from unintentional drug overdoses in 2007, driven to a large extent by prescription opioid overdoses. This is according to a press release from the University of North Carolina (UNC), referring to a publication in the Journal of Clinical Psychiatry describing the phenomenon, and offering advice to prescribers on how to deal with it.
One of the paper’s authors, Dr. Richard Weisler of UNC states in the release that “To put this in perspective, the number of 2007 U.S. unintentional drug poisoning deaths alone represents tragically about 4.6 times as many deaths as all U.S. fatalities in both Operation Iraqi Freedom and Operation Enduring Freedom in Afghanistan from the beginning of both wars through Feb 20, 2011.”
FDA’s response to the problem has been a series of educational initiatives for patients and physicians. Drug makers have responded by developing innovative formulations to discourage abuse of prescription opiates. This type of formulation work runs counter to the type of strategies that usually concern drug makers: generally, the idea is to get the drug to its target at high concentrations as fast as possible for as long as possible. In the case of opiates, they are tasked with getting the drug to target at therapeutic concentrations, but making it impossible to reach concentrations that are too high or reach them too quickly.
This week, Pain Therapeutics Inc. released results from its Phase III trials of its opiate REMOXY, an encapsulated, water insoluble, highly viscous, twice-daily oral formulation of oxycodone. The study met its endpoints, finding that patients did not like REMOXY as much as oxycodone, and could not chew it for more than 1.5 minutes, due to its unpleasant taste and texture. For this class of drugs, developing one that’s liked less than the competitor, and tastes terrible represents a rousing success.