Available information for OXYNEO - Submission control number 141379

1.07 General Note to Reviewer

• Anonymization Report

2.5 Clinical Overview

• Clinical Overview - Tamper Resistant

2.7.1 Summary of Biopharmaceutic Studies and Associated Analytical Methods

• Summary of Biopharmaceutic Studies and Associated Analytical Methods

2.7.2 Summary of Clinical Pharmacology Studies

• Summary of Clinical Pharmacology Studies

2.7.3 Summary of Clinical Efficacy

• Summary of Clinical Efficacy

2.7.4 Summary of Clinical Safety

• Summary of Clinical Safety

5.3.1.1 Bioavailability (BA) Study Reports

OTR1006 Randomized single-center open-label single-dose mutiple-treatment 4-period crossover study in healthy subject to determine PK and dose proportionality of OTR tablets in the fasted state

• Report Body

OTR1012 Randomized single-center open-label single-dose 3-treatment 3-period crossover study in healthy subject to determine PK and dose proportionality of OTR tablets in the fasted state

• Report Body

5.3.1.2 Comparative BA and Bioequivalence (BE) Study Reports

OTR1002 Randomized open-label single-center two-way crossover study in healthy subjects to determine FED BE of OTR 10 mg tablets to Oxycontin 10 mg tablets

• Report Body

OTR1003 Randomized open-label single-center single-dose two-way crossover study in healthy subjects to determine fasting BE of OTR 10 mg tablets to Oxycontin 10 mg tablets

• Report Body

OTR1004 Randomized open-label single-center single-dose two-way crossover study in healthy aubjects to determine FED BE of OTR 40 mg tablets to Oxycontin 40 mg tablets

• Report Body

OTR1005 Randomized open-label single-center single-dose two-way crossover study in healthy subjects to determine fasting BE of OTR 40 mg tablets to Oxycontin 40 mg tablets

• Report Body

OTR1008 Randomized open-label single-center single-dose two-way crossover study in healthy subjects to determine FED BE of OTR 80 mg tablets to Oxycontin 80 mg tablets

• Report Body

OTR1009 Randomized open-label single-center single-dose two-way crossover study in healthy subjects to determine fasting BE of OTR 80 mg tablets to Oxycontin 80 mg tablets

• Report Body

OTR1502 Open-label multiple-dose 3-treatment 3-period randomised crossover study to determine steady-state PK of OTR 80 mg tablets to Oxycontin 80 mg tablets in healthy subjects

• Report Body

5.3.1.3 In vitro - In vivo Correlation Study Reports

OTR1001 Randomized open-label single-dose 4-way crossover pilot study in healthy subject to assess PK and relative BA of Oxycodone following administration of 3 different OTR formulations in FED and fasted state compared to OxyContin

• Report Body

5.3.5.1 Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication

OTR1018 Single-center double-blind study in recreational opioid users to evaluate the abuse potential PK and safety of crushed and intranasally administered OTR tablets

• Report Body

5.3.5.2 Study Reports of Uncontrolled Clinical Studies

OTR1016 Randomised open-label single-dose crossover study of the effects of various tampering methods on exposure to Oxycodone in fasting healthy subjects

• Report Body

OTR1021 Randomised single-blind 3-way crossover study evaluating the safety tolerability and PK of crushed intranasal OTR tablets and Oxycotin in healthy adults

• Report Body

5.3.5.4 Other Study Reports

OTR1019 Relative Attractiveness of OTR - Comparative assessment of tampering potential and recreational drug user preferences for different opioid formulations

• Report Body

OTR1022 Single-center randomized cross-over study in recreational opioid users to evaluate the safety of crushed and intranasally administered OTR and OC placebo tablets

• Report Body