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Drugs and Health Products

Notice of Decision for NOXYNEO™

Control Number: 141379
Oxycodone hydrochloride, 10, 15, 20, 30, 40, 60, and 80 mg controlled-release tablets
Purdue Pharma
Notice of Compliance issued: August 22, 2011

Contact: Bureau of Cardiology, Allergy and Neurological Sciences (BCANS)


Date issued: November 26, 2012

On August 22, 2011, Health Canada issued a Notice of Compliance to Purdue Pharma for the drug product OxyNEO.

OxyNEO contains the medicinal ingredient oxycodone hydrochloride which is an opioid analgesic.

OxyNEO is indicated for:

Adults:
OxyNEO (oxycodone hydrochloride controlled-release tablets) is indicated for the relief of moderate to severe pain requiring the continuous use of an opioid analgesic preparation for several days or more.

Geriatrics (>65 years of age):
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, concomitant disease or other drug therapy.

Pediatrics (<18 years of age):
The safety and efficacy of OxyNEO has not been studied in the pediatric population. Therefore, the use of OxyNEO is not recommended in patients under 18 years of age.

Oxycodone is a semi-synthetic opioid analgesic which exerts an agonist effect at specific, saturable opioid receptors in the central nervous system (CNS) and other tissues.

The market authorization was based on quality and clinical information submitted demonstrating bioequivalence of OxyNEO to the previously marketed drug product OxyContin (oxycodone hydrochloride). A series of six single-dose crossover comparative bioavailability studies demonstrated that the OxyNEO 10, 40, and 80 mg tablets met the recommended standards for bioequivalence to corresponding strengths of OxyContin controlled-release tablets. The study data also support the proposed labelling and dosing recommendations with regard to food. The pharmacokinetics of oxycodone are dose-proportional over single-unit doses of 10 to 80 mg. The findings of the aforementioned studies conducted with the 10, 40, and 80 mg OxyNEO strengths may therefore be extended to the other strengths within the series [that is (i.e.), 15, 20, 30, and 60 mg tablets]. No additional clinical evidence was required as OxyNEO was demonstrated to be bioequivalent to OxyContin, which is considered safe and effective under the recommended conditions of use. There is, however, a higher choking risk with OxyNEO compared to OxyContin. Studies of abuse liability and a description of special physicochemical characteristics intended to decrease tampering were included in the submission but were not considered sufficient to allow any claims, nor were they considered pivotal to the decision to issue the Notice of Compliance.

OxyNEO (10, 15, 20, 30, 40, 60 and 80 mg oxycodone hydrochloride) is presented as controlled-release tablets. Individual dosing requirements vary considerably based on each patient’s age, weight, severity and cause of pain, and medical and analgesic history. OxyNEO tablets must be swallowed whole. Taking cut, broken, chewed, dissolved or crushed OxyNEO tablets could lead to the rapid release and absorption of a potentially fatal dose of oxycodone. The tablets are produced using unique manufacturing processes designed to reduce the possibility of being broken, crushed or chewed.

Due to the hydrogelling properties of the formulation, OxyNEO tablets can swell and pose a choking hazard. Appropriate labelling, including the insertion of a general warning and precaution statement regarding the risk of choking has been included within the Product Monograph. Post-marketing data in the United States reports that patients have experienced difficulty swallowing OxyNEO tablets. Should patients experience swallowing difficulties or pain after taking OxyNEO tablets, they are advised to seek immediate medical attention. To avoid difficulty swallowing, OxyNEO tablets should not be pre-soaked, licked or otherwise wetted prior to placing in the mouth and should be taken one tablet at a time with enough water to ensure complete swallowing immediately after placing it in the mouth. OxyNEO should not be taken by patients with difficulty in swallowing or who have been diagnosed with narrowing of the esophagus. Clear instructions describing the method of administration have been provided in the Product Monograph to reduce the risk of choking.

Do not administer OxyNEO via nasogastric, gastric or other feeding tubes as it may cause obstruction of feeding tubes.

OxyNEO 60 mg and 80 mg tablets, or a single dose greater than 40 mg are for use in opioid tolerant patients only. A single dose greater than 40 mg of oxycodone, or total daily doses greater than 80 mg of oxycodone, may cause fatal respiratory depression when administered to patients who are not tolerant to the respiratory depressant effects of opioids.

OxyNEO should not be used in the early post-operative period (12-24 hours post-surgery) unless the patient is ambulatory and gastrointestinal function is normal.

OxyNEO is not indicated for rectal administration.

The controlled-release tablets may be taken with or without food, with a glass of water.

Patients should be instructed not to give OxyNEO to anyone other than the patient for whom it was prescribed as such inappropriate use may have severe medical consequences, including death.

Patients should be cautioned not to consume alcohol while taking OxyNEO, as it may increase the chance of experiencing dangerous side-effects. Dosing guidelines are available in the Product Monograph.

OxyNEO (oxycodone hydrochloride controlled-release tablets) is contraindicated in:

  • Patients who are hypersensitive to the active substance (oxycodone) or other opioid analgesics or to any ingredient in the formulation.
  • In patients with known or suspected mechanical gastrointestinal obstruction [for example (e.g.), bowel obstruction, strictures] or any diseases/conditions that affect bowel transit (e.g., ileus of any type).
  • Patients with suspected surgical abdomen (e.g., acute appendicitis or pancreatitis).
  • Patients with mild, intermittent or short duration pain that can be managed with other pain medications.
  • The management of acute pain.
  • Patients with acute asthma or other obstructive airway, and status asthmaticus.
  • Patients with acute respiratory depression, elevated carbon dioxide levels in the blood, and cor pulmonale.
  • Patients with acute alcoholism, delirium tremens, and convulsive disorders.
  • Patients with severe CNS depression, increased cerebrospinal or intracranial pressure, and head injury.
  • Patients taking monoamine oxidase (MAO) inhibitors (or within 14 days of such therapy).
  • Women who are breast-feeding, pregnant, or during labour and delivery.

OxyNEO should be administered under the conditions stated in the Product Monograph taking into consideration the potential risks associated with the administration of this drug product. Detailed conditions for the use of OxyNEO are described in the Product Monograph.

Based on the Health Canada review of data on quality and comparative bioavailability, and the inclusion of recommendations on how to address the choking risk while swallowing the tablet, Health Canada considers that the benefit/risk profile of OxyNEO is favourable for the indication stated above.

Purdue Pharma, owner of the trademark OxyNEO.

Notices of Decision (NDs) are produced in accordance with the Summary Basis of Decision (SBD) initiative.