Press Release
New Abbott Study of Investigational Vicodin CR™ Meets Primary Efficacy Endpoints in Phase III Trial
Vicodin CR (hydrocodone bitartrate and acetaminophen) Extended Release
Tablets Twice-daily Regimen Significantly Lowered Chronic Low Back Pain
Intensity with 12-hour Dosing Compared to Placebo
May 8, 2008
Tampa — New Phase III study data showed that Abbott's (NYSE: ABT)
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™ (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® (hydrocodone bitartrate and acetaminophen
tablets, USP) Immediate Release
Vicodin® is a currently available, immediate-release medicine used for the
relief of moderate to moderately-severe pain.
About Vicodin® (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 www.rxabbott.com/pdf/vicodin.pdf.
About Abbott
Abbott (NYSE: ABT)
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.
Media:
Marylou McNally
DeAnna DuBose |
(847) 937-5125
(847) 938-9002 |
Financial:
Larry Peepo |
(847) 935-6722 |
