FDA Approves Tamper-Resistant Oxycodone

Susan Jeffrey

June 20, 2011

June 20, 2011 — Pfizer Inc and Acura Pharmaceuticals Inc announced today marketing approval from the US Food and Drug Administration (FDA) for a new formulation of oxycodone hydrochloride (HCl), USP tablets (Oxecta) CII. The new formulation is indicated for the management of acute and chronic moderate to severe pain when the use of an opioid analgesic is appropriate.

The product is an immediate-release oxycodone medication that applies technology designed to discourage common methods of tampering associated with opioid abuse and misuse, the companies said in a statement. This technology, known as Aversion Technology, uses commonly available pharmaceutical ingredients that, for example, cause the active ingredient to gel to prevent injection or to irritate nasal passages to discourage inhalation. Pfizer is licensing the technology in this product from Acura.

"Opioid medications are an important treatment option for patients with moderate to severe pain who are not adequately managed by other pain treatments," the companies note in their statement. "However, abuse and misuse of opioids is a serious public health issue that is the focus of a number of recent United States government initiatives."

In April, FDA released its long-awaited opioid plan, changing regulations for long-acting and extended-release opioids. The central component of the new opioid Risk Evaluation and Mitigation Strategy is an education program for prescribers. The agency will require drug makers to provide and pay for the plan, although the training is still not mandatory for prescribers.

Important Safety Information

This new product is contraindicated in patients with respiratory depression in unmonitored settings and in the absence of resuscitative equipment in any patient who has or is suspected of having paralytic ileus, in patients with acute or severe bronchial asthma or hypercarbia, and in patients with known hypersensitivity to oxycodone, oxycodone salts, or any components of the product, the company release notes.

Respiratory depression is the primary risk. This is more common in elderly or debilitated patients, in those with conditions such as chronic obstructive pulmonary disease, severe asthma, or upper airway obstruction, or after large initial doses of opioids given to nontolerant patients.

The product contains oxycodone HCl, an opioid agonist and a Schedule II controlled substance. "Oxecta can be abused in a manner similar to other opioids and narcotics," the release states. "This should be considered when prescribing or dispensing oxycodone HCl in situations where the physician or pharmacist is concerned about an increased risk of misuse or abuse."

This formulation can still be abused by crushing, chewing, snorting, or injecting the product. "These practices pose a significant risk to the abuser that could result in overdose and death," the companies point out. There is no evidence that this formulation has a reduced abuse liability compared with immediate-release oxycodone, they note.

Tablets should be taken with enough water to ensure complete swallowing immediately after placing in the mouth and must be swallowed whole. Because the formulation is not amenable to crushing and dissolution, it should not be used in nasogastric, gastric, or other feeding tubes because it may cause obstruction of the tubes.

Patients who have not been receiving opioid analgesics should start taking this drug in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain, the companies' release adds. The dose should be titrated based on the individual patient's response to their first dose. Patients with chronic pain may need to be dosed at the lowest dosage level that will achieve acceptable pain relief and tolerable adverse reactions, on an around-the-clock basis rather than on an as needed basis. When a patient no longer needs treatment after long-term use, it is important to gradually taper this product over time to prevent withdrawal symptoms, they note.

Patients taking this product in combination with other medicines, such as sedatives, anesthetics, or narcotics, may have serious problems, such as respiratory depression, low blood pressure, profound sedation, or coma, the statement adds.

It should be used with caution in patients with head injuries or other conditions that increase pressure in the brain, shock with low blood volume, severe undiagnosed abdominal conditions, history of seizures, severe kidney or liver disease, gall bladder disease, Addison's disease, hypothyroidism, and enlarged prostate or other illnesses that make urination difficult and in elderly or debilitated patients. It should also not be used in patients with intestinal obstruction, especially paralytic ileus.

The most common adverse reactions are nausea, constipation, vomiting, headache, itchiness, trouble sleeping, dizziness, loss of strength/energy, and sleepiness.

For additional prescribing information, call 1-800-776-3637.

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