Purdue Pharma”™s new OxyContin formula is a tougher nut to crack than the original.
The Stamford-based company is working with the the Food and Drug Administration (FDA) to develop a new version of its poplular and controversial pain medication.
Purdue has met with the Joint FDA Advisory Committee to discuss its new drug application (NDA) for OxyContin tablets with harder shells.
“We will continue to work with the FDA to seek approval of our NDA,” said John H. Stewart, president and CEO of Purdue Pharma. “We will also continue our ongoing discussions with the agency on the development and implementation of a risk evaluation and mitigation strategy as well as a carefully designed surveillance program to assess the impact of the new formulation in the market, should it be approved.”
OxyContin is listed as a Schedule II controlled substance with an abuse potential similar to morphine. It became vernacularly known as hillbilly heroin for its potency and rural popularity and hooked, among others, the conservative commentator Rush Limbaugh.
The new proposed version of the drug will be harder to crush and therefore more difficult to abuse. According to Purdue, broken, chewed or crushed tablets lead to rapid release and absorption of doses of oxycodone, a common method for abuse that could be potentially fatal.
Because the new formulation has not yet been approved by the FDA, Purdue Pharma could not make any further statements regarding the new version.
First generation OxyContin tablets have been and remain available by prescription from licensed professionals. The tablets were approved by the FDA in 1995. According to Stewart, the tablets are prescribed for the management of moderate to severe pain when a continuous, around-the-clock painkiller is needed for an extended period of time.
