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For Immediate Release Contact: James Heins Purdue Pharma Provides Update on Development FDA Cites Patient Needs As First Priority; New Drug Application Delayed Stamford, CT - (June 18, 2002) - Purdue Pharma L.P. announced today that the company and the U.S. Food & Drug Administration have determined that additional studies would be required to more fully assess the safety and effectiveness of the company's investigative drug combining the opioid analgesic oxycodone with the opioid antagonist naloxone. The NDA for this product was originally projected to be submitted to FDA by end of 2002. These further studies however, will substantially delay the company's NDA submission for its first abuse-resistant product. The company developed this formulation to reduce intravenous abuse, and potentially intranasal abuse, of OxyContin® (oxycodone HCl controlled release) Tablets as an interim solution in response to reports of intravenous abuse in late 2000. It was assumed to be the most rapid, albeit partial, solution. The company had been pursuing other approaches prior to the naloxone project and is continuing to develop these other new drug candidates, which may have greater potential to deter not only intravenous abuse, but also the more common oral and intranasal abuse after first crushing the tablet. Developing new forms of pain relievers that are safe and effective for patients with pain while being more resistant to abuse is Purdue Pharma's number one research priority. Over the past two years, the company's expenditures on abuse-resistant formulations have exceeded $100 million and Purdue expects to maintain a high level of investment over the next several years. "We are disappointed at this delay in our efforts to introduce a more abuse-resistant medication," said Paul Goldenheim, MD, Executive Vice President of Worldwide Research and Development at Purdue Pharma. "Developing new medications that are safe and effective for patients in pain, and at the same time, resistant to abuse, is a very complex scientific and technical challenge. Our first responsibility is to the health and safety of the millions of people with pain and we cannot introduce a product until we are confident it will not put these patients at risk or compromise their care. We had originally hoped to begin submitting data to the FDA as part of a new drug application for the oxycodone/naloxone product by the end of this year," he added. "It now looks as though we will not be able to complete clinical development of any new abuse-resistant product for at least four to five years." The company's recent Phase 1 studies have shown that the absorption or metabolism of naloxone is more variable than expected. Such variability has the potential to compromise pain relief in some patients. However, using lower doses of naloxone may not be sufficient to deter abuse. After reviewing the results of the company's clinical data, company and FDA officials agreed that additional studies would be needed to fully assess the safety of this drug formulation in patients with pain as well as its potential to deter abuse. Furthermore, naloxone has significant limitations as an abuse deterrent. According to law enforcement sources, the majority of abuse of OxyContin®occurs orally or intranasally after first crushing the tablets (the product's prescribing information has always clearly stated that OxyContin® Tablets are to be swallowed whole and are not to be broken, chewed or crushed). While the oxycodone/naloxone formulation would deter abuse by intravenous injection, and possibly by the intranasal route (snorting), orally administered naloxone is, in most cases, rapidly metabolized and eliminated from the body. Therefore, naloxone is unlikely to be an effective deterrent to oral abuse of crushed tablets. Purdue is committed to developing products with reduced abuse potential and is concurrently developing several abuse-resistant product candidates. Abusers first crush opioid medications and then take them orally, intranasally, or by injection. Crushing these new abuse-resistant products, however, would release an opioid antagonist into the bloodstream where it would counteract the opioid and block the euphoria sought by abusers. Patients, taking the medication as prescribed, however, would achieve the desired pain relief. This approach involves novel, complex formulation work using the antagonist naltrexone. While it is impossible to project a timeline with any certainty, the company expects it will be at least four to five years before it has sufficient data to support a new drug application for this experimental medication. "We will continue to work closely with the FDA and meet on a regular basis to make sure our research efforts continue to be in line with the agency's expectations," said Dr. Goldenheim. "While nothing will ever make opioid medications completely abuse-proof, our research suggests that it may be possible to make medications that are more difficult to abuse. As we pursue this important goal, we will continue to work with the law enforcement and medical communities on the most extensive program of prevention and education in the industry to curb pharmaceutical diversion and abuse. We have been told we are making a difference, and we are committed to stay the course." The professional product labeling for OxyContin® Tablets contains the following boxed warning:
Full prescribing information for OxyContin is available at http://www.purduepharma.com/PRESSROOM/PI/OXYCONTIN_PI.PDF. This and other recent announcements are available on the Purdue Pharma website at www.purduepharma.com |
