On Tuesday, April 16th, the FDA announced that they will not approve any new drug applications for generic OxyContin that rely upon the approval of the original formulation of OxyContin. The FDA also approved updated labeling for the newer, crush resistant formulation. The label will note that the reformulated product has physical and chemical properties to make abuse more difficult.
Purdue Pharma L.P. originally brought OxyContin (a long- acting opioid medication for the treatment of moderate to severe pain) on to the U.S. market in 1996, but in April 2010, the FDA approved a reformulated version of the drug that was resistant to crushing, chewing, breaking or dissolving in water to reduce its potential for abuse. The FDA noted that even though the original formulation has analgesic benefits similar to the reformulated OxyContin it posed increased potential for certain types of abuse and the benefits did not outweigh the risks. Therefore, the original OxyContin was withdrawn from sale for safety reasons.
What does this mean for the workers’ compensation industry and those involved in the MSA process? As Purdue’s exclusive rights to produce the original formulation of OxyContin was set to expire next week, generic pharmaceutical companies had begun looking at the prospect of gaining FDA approval to produce a lower cost version of the original OxyContin. With Tuesday’s announcement by the FDA, Purdue will have several more years of exclusive rights over the reformulated, abuse-resistant OxyContin as its patent is not set to expire until the year 2025. This means that the cost of the reformulated OxyContin will likely remain high which will lead to a large prescription allocation for injured individuals utilizing the medication for their workers compensation injury. PMSI’s PBM has numerous clinical programs to help target these individuals and can work with our clients early in the process to reduce claim costs which will lead to lower MSA allocations.