Purdue Pharma L.P. To Present Data From Research Studies at PAINWeek 2015 Annual Conference

Authors

Poster #

"Characterizing Downstream Healthcare Resource Utilization and Costs Based on Prior Utilization Patterns of Immediate Release Hydrocodone"

Ben-Joseph R, Bell JA, Abhishek C, Kansal A, Holly P, Paramore LC, Wild H 

9

"Opioid Treatment Patterns for Patients Prescribed Immediate-Release Hydrocodone"

Ben-Joseph R, Bell JA, Diana B, Kansal A, Paramore C, Abhishek C, Holly P, Burgoyne  D

10

"Trends in abuse, diversion, and fatalities in multiple surveillance systems four years after introduction of reformulated OxyContin"

Chilcoat HD, Coplan PM, Sessler NE 

29

"Patient Knowledge of Safe Use of ER/LA Opioid Analgesics Following Implementation of the Class-Wide REMS"

Esposito DB, Stephenson JJ, Cepeda MS, Coplan PM, Hawes JCL, Holick CN, Knox C, Maziere JY, Wedin GP, Lanes SF, and Members of the REMS Program Companies Metrics Subteam

38

"Incidence of Opioid and Heroin Overdose Among Patients Using ER/LA Opioid Analgesics Before and After Implementation of the Class-wide REMS"

Esposito DB, Cepeda MS, Coplan PM, Holick CN, Knox C, Liu N, Voijala SK, Maziere JV, Wedin GP, Lanes SF, Members of the REMS Program Companies Metrics Subteam

39

"A 24-Week Extension of a 12-month Open-label, Safety Study Evaluating the Safety and Effectiveness of Once-daily, Single-entity, Hydrocodone in Patients with Chronic Nonmalignant and Nonneuropathic Pain"

Wen W, Taber L, Lynch SY, He E, Ripa SR

59

"Long-term Effectiveness and Safety of Once-daily, Single-entity, Extended-release Hydrocodone in Patients of 75 Years of Age with Moderate to Severe Nonmalignant and Nonneuropathic Pain"

Broglio K, Pergolizzi J, Kowalski M, Lynch SY, He E, Wen W

60

"Change in the Rate of Diagnosed Opioid Addiction/Dependence Among Individuals Dispensed OxyContin after Its Reformulation with Abuse-Deterrent Characteristics Compared to Comparator Opioids"

Kadakia AR, Coplan PM, Chilcoat  HD

70

"In Vitro and In Vivo Evaluation of, and FDA Approved Labeling for, the Abuse-Deterrent Properties of Hysingla^® ER, a Once-daily, Single-Entity, Hydrocodone Bitartrate Formulation"

Cipriano A, Giordano J, Das S, Kapil RP, Colucci SV, Harris SC

71

"Pharmacokinetic Profile and Sustained 24-Hour Analgesia Following Administration of a Novel Hydrocodone Single-Entity, Once-Daily, Extended-Release Tablet [Hysingla^® ER] Formulated with Abuse-Deterrent Properties: Results of Two Studies"

Cipriano A, Wen W, Lynch SY, Harris SC, Kapil RP

72

Speakers

Date & Time

Location

"An Extended-Release Oral Hydrocodone Bitartrate Therapy"

Dr. Srinivas Nalamachu, MD, President, International Clinical Research Institute, Overland Park, KS

Joseph V. Pergolizzi, MD, Senior Partner, Naples Anesthesia and Pain Associates, Adjunct Associate Professor, Temple University School of Medicine

Wed., Sept. 9

8 9 a.m. PDT

Castellana Ballroom

Level 3

The Cosmopolitan 3708 S Las Vegas Blvd

Las Vegas, NV 89109

"Overview of Emerging Technologies: Opioids with Abuse-Deterrent Properties (OADP)"

J. David Haddox, DDS, MD, Vice President, Health Policy, Purdue Pharma L.P.

Jeffrey A. Gudin, MD,

Director, Pain Management and Palliative Care, Englewood Hospital and Medical Center

Thurs., Sept. 10

3:35 4:30 p.m. PDT

Mont Royal Ballroom

Level 4

The Cosmopolitan 3708 S Las Vegas Blvd

Las Vegas, NV 89109

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND CYTOCHROME P450 3A4 INTERACTION

Addiction, Abuse, and Misuse
HYSINGLA ER exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing HYSINGLA ER, and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions (5.1)].

Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of HYSINGLA ER. Monitor for respiratory depression, especially during initiation of HYSINGLA ER or following a dose increase. Instruct patients to swallow HYSINGLA ER tablets whole; crushing, chewing, or dissolving HYSINGLA ER tablets can cause rapid release and absorption of a potentially fatal dose of hydrocodone [see Warnings and Precautions (5.2)].

Accidental Ingestion
Accidental ingestion of even one dose of HYSINGLA ER, especially by children, can result in a fatal overdose of hydrocodone [see Warnings and Precautions (5.2)].

Neonatal Opioid Withdrawal Syndrome
Prolonged use of HYSINGLA ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.3)].

Cytochrome P450 3A4 Interaction
The concomitant use of HYSINGLA ER with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Monitor patients receiving HYSINGLA ER and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.11) and Clinical Pharmacology (12.3)].