The US Food and Drug Administration (FDA) approved Purdue Pharma LP's New Drug Application for a reformulation of OxyContin (oxycodone HCl controlled-release) tablets.
The reformulation has met FDA criteria for bioequivalence to the original formulation, which means there is no significant difference in the rate and extent of absorption of the therapeutic ingredient.
While similar in appearance to the original formulation, the reformulated tablets have a different marking ("OP") than the currently marketed tablets (marking "OC") and the 60 mg and 80 mg tablets are slightly larger in size than the currently marketed tablets.
Purdue elected to reformulate OxyContin to be bioequivalent to the original formulation and in an effort to make the tablet more difficult to manipulate for the purpose of intentional misuse and abuse, however, there is no evidence that the reformulation of OxyContin is less subject to misuse, abuse, diversion, overdose or addiction.
OxyContin continues to be a CII controlled substance with all the attendant risks of Schedule II opioids, specifically that the drug has a high potential for abuse. Use, misuse, or abuse of the drug may lead to physical dependence or addiction (addiction is sometimes referred to as "psychological dependence"). In addition, alteration of the tablet in any manner poses significant risks of overdose and death. The Full Prescribing Information contains warnings about the potential for abuse, diversion, overdose and addiction, including a boxed warning (see below).
The company expects to begin shipping all dosage strengths of the reformulated product (10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg and 80 mg) to distributors and pharmacies during the third quarter of 2010, at which time Purdue will cease shipping the original formulation.
"We will work with distributors and pharmacies for a smooth transition to the reformulation that will maintain product supply and protect patient access," said John H Stewart, president and CEO of Purdue Pharma LP
Purdue Pharma LP and its associated US companies are privately-held pharmaceutical companies known for pioneering research on persistent pain.