• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Directories » FDA Approved Drugs » Oxecta (oxycodone HCl)

AND
  • A
  • B
  • C
  • D
  • E
  • F
  • G
  • H
  • I
  • J
  • K
  • L
  • M
  • N
  • O
  • P
  • Q
  • R
  • S
  • T
  • U
  • V
  • W
  • X
  • Y
  • Z

Oxecta (oxycodone HCl)

  • Profile

Profile

Contact Information

Currently Enrolling Trials

    Show More

    General Information

    Oxecta is an immediate release tablet formulation of the opioid analgesic oxycodone HCl. This formulation was developed on Acura Pharmaceutical's patented Aversion Technology platform, which is designed to limit or impede opioid abuse via intravenous injection of dissolved tablets and nasal snorting of crushed tablets.

    Oxecta is specifically indicated for the management of acute and chronic moderate to severe pain where the use of an opioid analgesic is appropriate.

    Oxecta is supplied as a tablet that must be swallowed whole; it is not amenable to crushing and dissolution. The dose of Oxecta should be individually adjusted according to severity of pain, and the patient’s response, weight, age, and prior analgesic treatment experience. The recommended starting dose is in the range of 5 to 15 mg every 4 to 6 hours as needed for pain.

    Clinical Results

    FDA Approval
    Two phase 1 pharmacokinetic studies demonstrated (a) Oxecta tablets are bioequivalent to the anticipated reference listed drug under fasted conditions, and (b) Oxecta tablets have greater total oxycodone plasma levels with a lower peak drug concentration under fed compared to fasted conditions.

    Side Effects

    Serious adverse reactions that may be associated with Oxecta include the following:

    • respiratory depression
    • respiratory arrest
    • circulatory depression
    • cardiac arrest
    • hypotension
    • shock

    Adverse events associated with the use of Oxecta may include, but are not limited to, the following:

    • nausea
    • constipation
    • vomiting
    • headache
    • pruritus
    • insomnia
    • dizziness
    • asthenia
    • somnolence

    Mechanism of Action

    Oxecta is an immediate release tablet formulation of the opioid analgesic oxycodone HCl. This pure opioid agonist is relatively selective for the mu receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Oxecta was developed on Acura Pharmaceutical's patented Aversion Technology platform, which is designed to limit or impede opioid abuse via intravenous injection of dissolved tablets and nasal snorting of crushed tablets.

    Additional Information

    For additional information regarding Oxecta or the management of moderate to severe pain, please visit the Pfizer web page.

    Approval Date: 2011-06-01
    Company Name: Pfizer
    Back to Listings

    Upcoming Events

    • 26Jan

      Reducing Complexity in Starting Clinical Trials – More Patients, Faster Startup

    • 27Jan

      Medical Device Clinical Trials in China: Latest Regulatory Developments

    • 11Feb

      Lab X.0: Addressing Quality and Compliance Challenges in Laboratory Operations in the COVID-19 All-Digital Era

    • 23Mar

      Data Integrity for GCP Professionals: Core Requirements, Expectations and Challenges

    • 26Apr

      MAGI's Clinical Research vConference — Spring 2021

    Featured Products

    • Regenerative Medicine – Steps to Accelerate Development : PDF

      Regenerative Medicine: Steps to Accelerate Development

    • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

      Clinical Trial Agreements: A Guide to Key Words and Phrases

    Featured Stories

    • TechInnovation-360x240.png

      Pace of Technology Innovation in Trials Could Slow After Pandemic Eases

    • AskTheExperts-360x240.png

      Ask the Experts: Certifying and Maintaining Copies of Original Source Documents

    • Resources-360x240.png

      Trial Complexity, Endpoints Continue to Increase, Stretching Site Resources

    • FocusinRed-360x240.png

      Return to Focus on Risk Management Postpandemic Could Prove Challenging to Sites

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell My Personal Information

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 617.948.5100 – Toll free 866.219.3440

    Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing