May 07, 2010
EXALGO Provides 24-Hour Management of Moderate-to-Severe Chronic PainBALTIMORE, Md.—Patients with moderate-to-severe chronic pain can be successfully converted from prior opioid therapy to EXALGO™ (hydromorphone HCl) extended-release tablet, an extended-release (ER) oral formulation of hydromorphone HCl. Approved by the US Food and Drug Administration on March 1, 2010, EXALGO is the only ER formulation of hydromorphone available in the US.
Presenting at the American Pain Society 29th Annual Scientific Meeting, Perry G. Fine, MD, of the Pain Research Center at the University of Utah School of Medicine, Salt Lake City, provided an update on the management of moderate to severe pain, with the goal of achieving around-the-clock relief. He focused specifically on EXALGO, a once-daily novel treatment for chronic pain that delivers hydromorphone via the OROS delivery system, which uses osmosis to provide a steady rate of drug release. EXALGO is available is 8, 12, and 16 mg tablets.
The 1999-2002 US National Health and Nutrition Examination survey estimates the prevalence of chronic regional pain to be 11% and back pain, 10.1%. Annual costs of chronic pain for medical expenses, lost income, and lost productivity are estimated to be up to $100 billion, Dr. Fine said. One study found that during a 2-week period, 12.7% of the total US workforce experienced a loss in productive time, while active workers lose productive time costing an estimated $61.2 billion annually.
Pain remains undertreated: in a study of 805 individuals suffering from pain, more than 50% found it necessary to change physicians to gain pain relief. Specific reasons cited included unwillingness to treat pain aggressively, failure to take pain seriously, and lack of knowledge about pain management. In addition to clinician barriers, patient and healthcare system barriers to treatment of chronic pain have been identified that range from communication problems to lack of a neighborhood pharmacy.
Several clinical studies have shown EXALGO to be superior to placebo in controlling moderate to severe chronic lower back pain. In the pivotal clinical trial, a multicenter, randomized, double-blind, placebo-controlled phase III study, 806 patients were screened and stabilized, 459 were converted and titrated, then 268 were randomized to a fixed dose of OROS hydromorphone for 12 weeks (n=134) or to a 2-week taper followed by 10 weeks of placebo (n=134).
At week 12, the 66 patients completing the study who received OROS hydromorphone had a significant reduction in pain intensity vs the 44 who completed the study in the placebo arm (P<0.001). Patients in the treatment group also had a reduction in disability scores. Adverse events were typical of those observed with other opioids.
EXALGO is 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. Patients considered opioid tolerant are those who are taking at least oral morphine 60 mg/day, transdermal fentanyl 25 mcg/hour, oral oxycodone 30 mg/day, oral hydromorphone 8 mg/day, oral oxymorphone 25 mg/day, or an equianalgesic dose of another opioid for a week or longer.
EXALGO should not be prescribed as the first opioid, and all other ER opioid medications should be discontinued when beginning therapy. When converting from prior opioid therapy to EXALGO, the equivalent dose should be calculated using the dose conversion in the prescribing information. EXALGO therapy should be started by administering 50% of the calculated total daily dose of EXALGO every 24 hours. The initial dose of EXALGO can be titrated up until adequate pain relief with tolerable side effects has been achieved. As a Schedule II controlled substance, EXALGO has a Boxed Warning. EXALGO is not intended for use as an as needed analgesic and is not indicated for the management of acute or postoperative pain.