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Purdue Pharma to Present Data Describing Changes in Oxycodone Abuse in Rural Kentucky Following the Introduction of Reformulated Oxycontin ® (Oxycodone HCl Controlled-Release) at the College on Problems of Drug Dependence 2013 Annual Meeting


6/18/2013 10:30:35 AM

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SAN DIEGO, June 17, 2013 – Purdue Pharma L.P. will present a poster describing the changes in abuse of OxyContin® and immediate-release oxycodone in rural Kentucky following the August 2010 introduction of reformulated OxyContin. This data is composed of follow-up interviews with a cohort of individuals in Kentucky who self-identified as original OxyContin abusers and will be presented at the College on Problems of Drug Dependence (CPDD) 75th Annual Meeting June 15 to 20 in San Diego.

Details of the scheduled poster presentation follows:

? Monday, June17, 8:00-10:00 a.m. PDT, Poster No. 73

? “Abuse of OxyContin and immediate-release (IR) oxycodone in a rural Kentucky county following introduction of reformulated OxyContin – results from 6-month follow-up interviews” A. DeVeaugh-Geiss, C. Leukefeld, J. Havens, H. Kale, P. Coplan, H. Chilcoat

Study participants (individuals that reported abuse of original OxyContin prior to the reformulation) were initially interviewed about their drug use before and after the introduction of reformulated OxyContin, followed by six-month follow-up interviews.

Among the 164 participants who completed the 6-month follow-up interviews, 76 percent selected original OxyContin as their preferred drug prior to the reformulation. In contrast, 66 percent of this population selected immediate-release oxycodone as their preferred drug after the reformulation; only one participant selected reformulated OxyContin as his or her preferred drug.

In follow-up interviews, 23 percent of participants reported attempting to manipulate the reformulated OxyContin for purposes of abuse.

From the initial interviews following the reformulation to the 6-month follow-up, the overall prevalence of original OxyContin abuse declined from 60 percent to 11 percent, and the overall frequency of abuse among those who abused declined from 11.3 days per month to 3.3 days per month.

During the same time period, prevalence of reformulated OxyContin abuse declined from 33 percent to 18 percent, while frequency among those who abused remained stable at 5.9 days per month vs. 5.7 days per month.

A decline in the prevalence of immediate-release oxycodone abuse, from 96 percent to 85 percent, also was observed during this time, while the frequency of abuse remained relatively constant.

Some abuse of OxyContin continued, and further research is necessary to determine whether similar effects are observed in other populations that abuse or misuse OxyContin.

The research was funded by Purdue Pharma L.P.

The professional product labeling contains the following boxed warning:

WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, and ACCIDENTAL EXPOSURE

Abuse Potential

OxyContin® contains oxycodone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit [see Warnings and Precautions (5.1)]. Assess each patient’s risk for opioid abuse or addiction prior to prescribing OxyContin. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving OxyContin for signs of misuse, abuse, and addiction during treatment [see Drug Abuse and Dependence (9)].

Life-Threatening Respiratory Depression

Respiratory depression, including fatal cases, may occur with use of OxyContin, even when the drug has been used as recommended and not misused or abused [see Warnings and Precautions (5.2)]. Proper dosing and titration are essential and OxyContin should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of OxyContin or following a dose increase. Instruct patients to swallow OxyContin tablets intact. Crushing, dissolving, or chewing the tablet can cause rapid release and absorption of a potentially fatal dose of oxycodone.

Accidental Exposure

Accidental ingestion of OxyContin, especially in children, can result in a fatal overdose of oxycodone [see Warnings and Precautions (5.3)].

Indications and Usage

OxyContin is indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Limitations of Use

OxyContin is not for use:

? As an as-needed (prn) analgesic

? For pain that is mild or not expected to persist for an extended period of time

? For acute pain

? In the immediate postoperative period

? For postoperative pain, unless the patient is already receiving chronic opioid therapy prior to surgery, or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time

OxyContin 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for patients in whom tolerance to an opioid of comparable potency is established. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.

Contraindications

OxyContin is contraindicated in patients with:

? Significant respiratory depression

? Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment

? Known or suspected paralytic ileus and gastrointestinal obstruction

? Hypersensitivity (e.g., anaphylaxis) to oxycodone

Additional Safety Information Elderly cachectic, and debilitated patients, and patients with chronic obstructive pulmonary disease should be monitored closely because of increased risk of respiratory depression.

Hypotension, profound sedation, coma, or respiratory depression may result if OxyContin is used concomitantly with other CNS depressants, including alcohol and/or illicit drugs that can cause CNS depression. Start with a lower OxyContin dose and consider dose reduction of the concomitant CNS depressant because of additive effects. Monitor patients for signs of sedation and respiratory depression.

OxyContin may cause severe hypotension. Monitor patients at increased risk of hypotension during dose initiation and titration. Avoid use of OxyContin in patients with circulatory shock.

In patients with head injury or increased intracranial pressure, monitor for signs of sedation and respiratory depression. Avoid use of OxyContin in patients with impaired consciousness or coma susceptible to intracranial effects of CO2 retention.

Use caution when prescribing OxyContin for patients who have difficulty swallowing, or have underlying GI disorders that may predispose them to obstruction. Consider use of an alternative analgesic in these patients.

OxyContin may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.

OxyContin may aggravate convulsions in patients with convulsive disorders and may induce or aggravate seizures in some clinical settings. Monitor patients with a history of seizure disorders for worsened seizure control.

Avoid the use of mixed agonist/antagonist analgesics, as they may reduce the analgesic effect and/or precipitate withdrawal. Do not abruptly discontinue OxyContin.

OxyContin may impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.

Concomitant use of CYP3A4 inhibitors may prolong opioid effects. Use with CYP3A4 inducers may cause lack of efficacy or development of withdrawal symptoms. If co-administration is necessary, evaluate patients frequently and consider dose adjustments until stable drug effects are achieved.

OxyContin may increase the risk of serious adverse reactions such as those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, or shock. The most common adverse reactions (>5%) reported by patients in clinical trials comparing OxyContin with placebo are: constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, asthenia, and sweating.

Full prescribing information for OxyContin® is available at www.purduepharma.com/OxyContinPI.

About Purdue Pharma L.P.

Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on persistent pain. Headquartered in Stamford, CT, Purdue Pharma 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

Contact:

Jim Heins

Senior Director, Public Affairs

Tel: 203-588-8069

Cell: 203-856-2121

Email: james.heins@pharma.com

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