Exalgo (hydromorphone hydrochloride) extended release

Company
Alza

Approval Status
Approved March 2010

Treatment for
moderate to severe pain

Areas
Neurology & Nervous System

Exalgo is an extended release formulation of hydromorphone hydrochloride, a Schedule II a mu-opioid agonist. It utilizes the OROS PUSH-PULL osmotic delivery system to release hydromorphone at a controlled rate over an extended period. As an opioid agonist, the principle therapeutic action of hydromorphone is analgesia. The precise mechanism of action of opioid analgesics is not known but the effects are thought to be mediated through opioid-specific receptors located predominantly in the central nervous system.

Exalgo is specifically indicated for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.

Exalgo is supplied as a tablet for orral administration. Dosage should be individualized according to each patient's nneds. The dose range of Exalgo studied in clinical trials was 8 mg to 64 mg. The tablets are to be administered every 24 hours with or without food and all other extended-release opioids should be discontinued.

FDA Approval
The FDA approval of Exalgo was based in part on a double-blind, placebo-controlled, randomized withdrawal study in opioid tolerant patients with moderate-to-severe low back pain. The patients were considered opioid tolerant if they were currently on opioid therapy that was ≥60 mg/day of oral morphine equivalent for at least 2 months prior to screening. The patients entered an open-label conversion and titration phase with Exalgo, were converted to a starting dose that was approximately 75% of their total daily morphine equivalent dose, and were dosed once daily until adequate pain control was achieved with tolerable side effects. The patients who achieved a stable dose entered a 12-week, double-blind, placebo-controlled, randomized treatment phase. Mean daily dose at randomization was 37.8 mg/day. Exalgo provided superior analgesia compared to placebo. There was a significant difference between the mean changes from Baseline to Week 12 or Final Visit in average weekly pain intensity NRS scores obtained from patient diary between the two groups.

Adverse reactions associated with the use of Exalgo may include, but are not limited to, the following:

  • constipation
  • nausea
  • vomiting
  • somnolence
  • headache
  • dizziness

Exalgo is an extended release formulation of hydromorphone hydrochloride, a Schedule II a mu-opioid agonist. It utilizes the OROS PUSH-PULL osmotic delivery system to release hydromorphone at a controlled rate over an extended period. As an opioid agonist, the principle therapeutic action of hydromorphone is analgesia. The precise mechanism of action of opioid analgesics is not known but the effects are thought to be mediated through opioid-specific receptors located predominantly in the central nervous system.

For additional information regarding Exalgo or the management of moderate to severe pain, please visit the Exalgo web page.

Exalgo (hydromorphone hydrochloride) extended release Drug Information

The Exalgo (hydromorphone hydrochloride) extended release drug information shown above is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.

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