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Home | Clinical Trials

FDA Approved Drugs » 2011
Medical Areas: Neurology | Pharmacology/Toxicology | Family Medicine

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Oxecta (oxycodone HCl)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Pfizer
Approval Status: Approved June 2011
Treatment Area: acute and chronic moderate to severe pain

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.


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