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FDA Approved Drugs » 2010
Medical Areas: Neurology | Family Medicine

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Exalgo (hydromorphone hydrochloride) extended release

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Alza
Approval Status: Approved March 2010
Treatment Area: moderate to severe pain

General Information

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.

Clinical Results

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.

Side Effects

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

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

Mechanism of Action

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.

Literature References

Wallace M, Moulin DE, Rauck RL, Khanna S, Tudor IC, Skowronski R, Thipphawong J Long-term safety, tolerability, and efficacy of OROS hydromorphone in patients with chronic pain. Journal of Opioid Management 2009 Mar-Apr;5(2):97-105

Wallace M, Rauck RL, Moulin D, Thipphawong J, Khanna S, Tudor IC Conversion from standard opioid therapy to once-daily oral extended-release hydromorphone in patients with chronic cancer pain. The Journal of International Medical Research 2008 Mar-Apr;36(2):343-52

Hale M, Tudor IC, Khanna S, Thipphawong J Efficacy and tolerability of once-daily OROS hydromorphone and twice-daily extended-release oxycodone in patients with chronic, moderate to severe osteoarthritis pain: results of a 6-week, randomized, open-label, noninferiority analysis. Clinical Therapeutics 2007 May;29(5):874-88

Weinstein SM, Shi M, Buckley BJ, Kwarcinski MA Multicenter, open-label, prospective evaluation of the conversion from previous opioid analgesics to extended-release hydromorphone hydrochloride administered every 24 hours to patients with persistent moderate to severe pain. Clinical Therapeutics 2006 Jan;28(1):86-98

Grosset AB, Roberts MS, Woodson ME, Shi M, Swanton RE, Reder RF, Buckley BJ Comparative efficacy of oral extended-release hydromorphone and immediate-release hydromorphone in patients with persistent moderate to severe pain: two randomized controlled trials. Journal of Pain and Symptom Management 2005 Jun;29(6):584-94

Additional Information

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


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