What is the justification for prescribing oxymorphone (Opana) 7.5 milligrams for pain management in a patient?

From the Guidelines

I strongly recommend against prescribing oxymorphone (Opana) 7.5 milligrams as a first-line treatment for pain management due to its potential for misuse, overdose, and other serious risks, as highlighted in the CDC clinical practice guideline for prescribing opioids for pain - United States, 2022 1.

Key Considerations

• The CDC guideline emphasizes that ER/LA opioids, including oxymorphone, should be reserved for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment when alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain 1.
• The guideline also notes that ER/LA opioids should not be used as as-needed pain relievers and that clinicians should not treat acute pain with ER/LA opioids or initiate opioid treatment for subacute or chronic pain with ER/LA opioids 1.
• A study published in the Annals of Emergency Medicine in 2012 provides recommendations for prescribing opioids for adult patients in the emergency department, including the use of short-acting oral opioid formulations, but emphasizes that long-acting or extended-released schedule II products, such as oxycodone ER (OxyContin), methadone, fentanyl patches, or morphine extended-release (MS Contin), are indicated for chronic pain and should not be used for acute pain 1.

Patient-Specific Factors

• Before considering oxymorphone or any other opioid, a comprehensive evaluation of the patient's pain, including its severity, impact on daily functioning, and underlying causes, is necessary.
• A documented risk assessment using tools like the Opioid Risk Tool should be performed to evaluate the patient's risk for misuse, and regular urine drug screening should be considered to monitor appropriate medication use.
• The treatment plan should include regular follow-up appointments to monitor efficacy and side effects, with clear documentation of functional improvement goals rather than just pain reduction.

Alternative Treatment Options

• Alternative treatment options, such as nonopioid analgesics, immediate-release opioids, or other therapies, should be considered before initiating treatment with oxymorphone or any other ER/LA opioid.
• The patient's response to previous treatments, including any adverse effects or lack of efficacy, should be taken into account when selecting an alternative treatment option.

From the FDA Drug Label

OPANA is indicated for the relief of moderate to severe acute pain where the use of an opioid is appropriate.

1. 1 Individualization of Dosage As with any opioid drug product, it is necessary to adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience

Opioid-Naïve Patients Patients who have not been receiving opioid analgesics should be started on OPANA in a dosing range of 10 to 20 mg every four to six hours depending on the initial pain intensity.

The justification for prescribing oxymorphone (Opana) 7.5 milligrams for pain management in a patient is not directly stated in the label, as the recommended dosing range for opioid-naïve patients is 10 to 20 mg every four to six hours. However, the label does emphasize the importance of individualizing treatment and titrating the dose to achieve adequate pain relief while minimizing adverse experiences. Since 7.5 mg is below the recommended starting dose for opioid-naïve patients, it may be considered for patients who require a lower dose due to factors such as renal or hepatic impairment or geriatric status 2.

From the Research

Justification for Prescribing Oxymorphone

The justification for prescribing oxymorphone (Opana) 7.5 milligrams for pain management in a patient can be based on several studies that have demonstrated its effectiveness in managing chronic pain.

• Oxymorphone is a typical mu-opioid agonist that is effective in both immediate- and extended-release (IR and ER) formulations, providing excellent pain relief for significant pain with typical opioid side effects that are usually mild or moderate in intensity 3.
• A study on titration with oxymorphone extended release to achieve effective long-term pain relief and improve tolerability in opioid-naive patients with moderate to severe pain found that the majority of patients were stabilized on a dose of oxymorphone ER that provided effective pain relief with tolerable adverse events 4.
• A systematic review of oxymorphone in the management of chronic pain found that oxymorphone is superior to placebo, with daily doses of 40-100mg being effective for pain control, although the estimate of the treatment effect is imprecise 5.

Effective Dose and Administration

• The effective dose of oxymorphone for pain management can vary depending on the individual patient and the specific condition being treated.
• A study on oxymorphone extended release for the treatment of chronic low back pain found that the dose of oxymorphone ER was titrated to a stable, tolerable, effective dose, with a significant difference in VAS pain scores between the oxymorphone ER and placebo groups 6.
• Another study found that oxymorphone provides a new therapeutic option for the physician, with a duration of action of approximately 4-6 hours in IR and 12 hours in ER preparations 3.

Safety and Tolerability

• Oxymorphone has been found to be generally well tolerated, with the most frequent treatment-emergent adverse events being nausea, constipation, vomiting, and diarrhea 6.
• A study on the effectiveness and tolerability of a program of gradual dose titration with oxymorphone extended release found that gradual titration was well tolerated, with a low rate of discontinuations caused by adverse events 4.
• However, as with any opioid medication, there is a risk of opioid-related adverse events, and patients should be closely monitored for signs of addiction or abuse 7.