General Information

Avinza is an extended-release formulation of morphine sulfate, an opioid agonist.

Avinza is specifically indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Avinza is supplied as an extended release tablet for oral administration. Avinza should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

Avinza 90 mg and 120 mg capsules are for use only in patients in whom tolerance to an opioid of comparable potency has been established. Patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, or an equianalgesic dose of another opioid.

Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse. Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy with Avinza.

Avinza capsules must be taken whole. Crushing, chewing, or dissolving the capsules will result in uncontrolled delivery of morphine and can lead to overdose or death. Patients who are unable to swallow Avinza should be instructed to sprinkle the capsule contents on applesauce and immediately swallow without chewing.

Avinza is administered at a frequency of once daily (every 24 hours).

Use of Avinza as the First Opioid Analgesic:

Initiate treatment with Avinza with 30 mg capsule orally every 24 hours. Adjust the dose in increments not greater than 30 mg every 3 to 4 days.

Use of Avinza in Patients who are not Opioid Tolerant:

The starting dose for patients who are not opioid tolerant is Avinza 30 mg orally every 24 hours. Patients who are opioid tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, or an equianalgesic dose of another opioid.

Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.

See drug label for conversion from other opioids.

Mechanism of Action

Avinza is made up of two components: an immediate-release component that rapidly achieves plateau morphine concentrations in plasma, and an extended-release component that maintains plasma concentrations throughout the 24-hour dosing interval. Avinza creates and maintains the plateau-like plasma concentration profile after steady-state plasma morphine concentrations have been achieved.

Clinical Trial Results

Controlled and open-label clinical trials were conducted to test the safety and efficacy of Avinza. A total of approximately 140 healthy subjects and 560 subjects with chronic, moderate-to-severe pain from malignant and non-malignant disease sources were involved in these studies. The duration of the controlled clinical studies ranged from seven days to up to four weeks. Subjects in the open-label studies were observed for six to 12 months.

In one study, 295 subjects with chronic pain from osteoarthritis received either placebo or once-daily treatment with Avinza 30 mg in the morning or evening. Results showed that Avinza was significantly more effective at reducing pain than placebo.

Pharmacokinetic studies indicated that the amount of morphine absorbed from Avinza extended-release formulation was similar to that absorbed from other oral morphine formulations. Furthermore, the pharmacokinetics of Avinza were shown to be dose-proportional for both healthy subjects and subjects with moderate-to-severe pain.