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40/ taken first

Phase 2

Opioid Abuse | Small molecule | Psychiatry |Pfizer, Inc.|Last Updated: Nov 1, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment49

FDA Designations

No designations recorded

Clinical trial landscape

40/ taken first · 1 trial · 1 indication

Phase 2 1
NCT01030406Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid UsersOpioid Abuse
COMPLETED49 Analytics
PHASE2COMPLETED
Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users
Opioid AbuseUnlock trial analytics

Study Endpoints

Primary Endpoints

Drug Liking at .5 Hours
Measure collected at 0.5 hours post-dose

Drug Liking/Disliking Assessment on a 101 point bipolar visual analog scale (VAS) used to assess response to the question "Do you dislike or like the drug effect you are feeling now?" and anchored in the center with "Neither like nor dislike" (score of 50), on the left with "Dislike an awful lot" (score of 0) and on the right with "Like an awful lot" (score of 100).

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
40/0mg taken firstACTIVE_COMPARATOR8x oxycodone/niacin 5/0mg tablets
80/0mg taken firstACTIVE_COMPARATOR8x oxycodone/niacin 10/0mg tablets
40/240mg taken firstEXPERIMENTAL8x oxycodone/niacin 5/30mg tablets
80/480mg taken firstEXPERIMENTAL8x oxycodone/niacin 10/60mg tablets
0/0mg taken firstPLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
40/0mg taken firstDRUG8x Oxycodone/Niacin 5/0mg tablets All arms taken with a 48 hour washout between doses
80/0mg taken firstDRUG8x Oxycodone/Niacin 10/0mg tablets All arms taken with a 48 hour washout between doses
40/240mg taken firstDRUG8x Oxycodone/Niacin 5/30mg tablets All arms taken with a 48 hour washout between doses
80/480mg taken firstDRUG8x Oxycodone/Niacin 10/60mg tablets All arms taken with a 48 hour washout between doses
0/0mg taken firstDRUGPlacebo All arms taken with a 48 hour washout between doses
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subject is male or female between 18 and 55 years old. * Subject is in generally good health, including no history of pulmonary disease, and has a body mass index (BMI) within 18-33 kg/m2. * Subject is a recreational opioid user (i.e., at least 10 occasions within the past 12 ...

Countries:United States
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Frequently asked questions about 40/ taken first

What is Acurox used for?

Acurox is an investigational small molecule being studied for opioid abuse. It was evaluated in a Phase 2 clinical trial in non-dependent recreational opioid users to assess its relative abuse potential. The drug is not approved and remains in clinical development.

Who is developing Acurox?

Acurox is being developed by Pfizer, Inc. (NYSE: PFE). The company conducted a Phase 2 study of the drug in the United States for opioid abuse.

What phase is Acurox in?

Acurox is in Phase 2 clinical development. A Phase 2 study of the drug has been completed. Acurox is investigational and has not been approved by the FDA.

What clinical trials is Acurox in?

Acurox was studied in a completed Phase 2 trial, NCT01030406, titled "Study of the Relative Abuse Potential of Acurox Tablets in Non-Dependent Recreational Opioid Users." The trial enrolled 49 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is Acurox the same as any other drug?

Acurox is the name used in clinical trials for this investigational drug. No alternative names have been reported for Acurox in the context of its development for opioid abuse.