Statement of Purdue Pharma L.P. Regarding Joint Meeting of the U.S. Food and Drug Administration’s (FDA) Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
Stamford, CT – September 24, 2009 – Purdue Pharma L.P. appreciates the feedback received at today’s Joint FDA Advisory Committee meeting on our New Drug Application (NDA) for a new formulation of OxyContin® (oxycodone HCl controlled-release) Tablets.
“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.”
Since the new formulation has not been approved by the FDA, Purdue Pharma cannot make any further statements regarding it or the NDA at this time.
OxyContin® Tablets have been and remain available by prescription from licensed healthcare professionals. Approved by the FDA in 1995, OxyContin® Tablets are indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.
Untreated and undertreated pain is a serious public health issue in the United States. Purdue Pharma remains committed to developing and identifying new medicines for healthcare professionals to use in caring for people with pain.
Purdue Pharma L.P. is a privately-held pharmaceutical company known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at www.purduepharma.com.
The professional product labeling for OxyContin® Tablets contains the following boxed warning:
WARNING: OxyContin is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to morphine.
Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing OxyContin in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock analgesic is needed for an extended period of time.
OxyContin Tablets are NOT intended for use as a prn analgesic.
OxyContin 60 mg, 80 mg, and 160 mg Tablets, or a single dose greater than 40 mg, ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. A single dose greater than 40 mg, or total daily doses greater than 80 mg, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids.
OxyContin TABLETS ARE TO BE SWALLOWED WHOLE AND ARE NOT TO BE BROKEN, CHEWED, OR CRUSHED. TAKING BROKEN, CHEWED, OR CRUSHED OxyContin TABLETS LEADS TO RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF OXYCODONE.
Full prescribing information for OxyContin is available at