New Abbott Study of Investigational Vicodin CR(TM) Meets Primary Efficacy Endpoints in Phase III Trial

TAMPA, May 8 /PRNewswire-FirstCall/ -- New Phase III study data showed that Abbott's investigational hydrocodone bitartrate and acetaminophen (HC/APAP) extended release medicine reduced pain in patients with moderate to severe chronic low back pain, one of the most common causes of chronic pain. Taken twice daily in the clinical trial, Vicodin CR(TM) (HC/APAP extended release) significantly lowered chronic low back pain intensity with 12-hour dosing versus placebo. Currently available short-acting HC/APAP combinations must be taken every four to six hours throughout the day. The study results were presented at the American Pain Society's 27th Annual Scientific Meeting in Tampa.

One in four American adults (75 million) suffer chronic and acute pain, with lower back pain and headache as the most common types of pain. According to the American Pain Foundation, back pain is the leading cause of disability in Americans under 45 years old and two-thirds of adults will have back pain during their lifetime.

"Immediate-release hydrocodone with acetaminophen has four to six hour dosing and is the most prescribed medication in pain care today," says Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott. "These new extended-release data are encouraging because they showed that 12-hour dosing provided pain relief in patients with moderate to severe chronic low back pain."

About the Study

The efficacy of HC/APAP extended release was assessed in patients with moderate to severe chronic low back pain in a multi-center, double-blind, placebo-controlled, withdrawal-design trial of 773 patients. Eligible participants entered a three-week active-drug, open-label period in which all patients were titrated to receive two tablets of HC/APAP extended release, twice daily. At the end of the open-label period, 511 patients entered the 12-week double-blind portion of the study and were randomized to receive one tablet of HC/APAP extended release, two tablets HC/APAP extended release or placebo twice daily. The primary efficacy endpoint was measured as change in patients' assessments of pain intensity based on a validated assessment tool, a visual analog scale, and compared to baseline. All results reported are from the double-blind portion of the study.

Study Results

HC/APAP extended release met the primary and secondary efficacy endpoints compared to placebo. The mean change from baseline chronic low back pain intensity was significantly lower in patients receiving either one or two tablets taken twice daily of HC/APAP extended release compared to those taking placebo (8.6, two tablet, p=0.001; 13.3, one tablet, p=0.002 versus 22.2, placebo). An assessment of the multiple secondary efficacy endpoints was supportive of the primary findings. With 12-hour dosing, the pain was reduced during the 12-week treatment period.

The most common adverse events in any treatment group were nausea, constipation, diarrhea and headache. In the HC/APAP extended release two- tablet group, 53 percent of patients and 44 percent in the one-tablet group reported adverse events. Of the patients in the placebo group 46 percent reported adverse events. Twenty-eight patients discontinued due to adverse events (3 percent in placebo group, 6 percent in the one-tablet group and 7 percent in the two-tablet group) and nine patients reported serious adverse events (two in each HC/APAP group and five in the placebo group). These adverse events are considered typical for opioid analgesic therapy.

About Hydrocodone Bitartrate and Acetaminophen Extended Release

HC/APAP extended release is an investigational formulation with 12-hour dosing, currently in clinical development for the relief of moderate to moderately-severe pain. The New Drug Application for Abbott's Vicodin CR was submitted to the U.S. Food and Drug Administration in the fourth quarter of 2007.

About Abbott's Commitment to Appropriate Use of Pain Medication

Opioids and other pain medications are important treatment options for patients living with chronic and acute pain who need relief. Despite this medical need, prescription opioid pain medications have well-known risks for abuse, misuse and diversion for illegitimate use. To address these issues, Abbott has designed risk management strategies that include professional, patient and public education programs, abuse surveillance programs, product packaging initiatives and controls on supply chain integrity. Abbott recognizes its role as a partner in a broad effort to help educate the public about the dangers of potential abuse, misuse and diversion of prescription pain medications and to help keep pain medicines in the appropriate hands of health care professionals and patients with a genuine medical need.

About Vicodin(R) (hydrocodone bitartrate and acetaminophen tablets, USP) Immediate Release

Vicodin(R) is a currently available, immediate-release medicine used for the relief of moderate to moderately-severe pain.

About Vicodin(R) (hydrocodone bitartrate and acetaminophen tablets, USP) Immediate Release - Important Safety Information

HC/APAP immediate release tablet should not be used if a patient is allergic to hydrocodone or acetaminophen. Patients should tell a health care provider if they are allergic to any other opioid painkillers before taking this drug, as there may be cross sensitivity to hydrocodone. HC/APAP can cause breathing irregularities at high doses or in sensitive patients. Patients should talk with a health care provider before taking HC/APAP if they had a recent head injury. HC/APAP can be habit-forming and may be abused. Patients should take this drug only for the condition for which it was prescribed, for as long as it is prescribed, in the amount prescribed and no more frequently than prescribed. This drug should not be given to others even if they have similar symptoms. Taking HC/APAP may make patients drowsy, impair their ability to drive a car, operate machinery or perform other potentially dangerous activities. Patients should avoid taking HC/APAP with alcohol or other depressants. Patients should talk to a health care provider about all prescription and non-prescription medicines, vitamins and herbal supplements they are taking to avoid possible serious drug interactions.

The elderly or disabled should use HC/APAP with caution. Patients with any of the following medical conditions should use HC/APAP with caution: liver or kidney problems, adrenal or thyroid gland problems, enlarged prostate or difficulty urinating, lung disease, current or past problems with alcohol or drug abuse or stomach problems. Patients who are pregnant or plan to become pregnant should not take HC/APAP unless directed to do so by a health care provider. The effects of this drug in pregnancy have not been adequately studied. Drug dependence has occurred in newborns when the mother has regularly taken this drug before delivery. The most common side effects of HC/APAP are lightheadedness, dizziness, drowsiness, nausea, vomiting and constipation. More information about Vicodin immediate release, including full prescribing information, is available on the Web site http://www.rxabbott.com/pdf/vicodin.pdf.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs more than 68,000 people and markets its products in more than 130 countries. Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com/.