Phase 3 Clinical Study of RELISTOR Presented at American Pain Society Meeting Showed Positive Activity for the Treatment of O...
May 07 2009 - 8:00AM
Business Wire
Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), and
Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced
results from the one-month, double-blind portion of a phase 3 trial
of RELISTOR� (methylnaltrexone bromide) subcutaneous injection that
are scheduled to be presented tomorrow at the annual meeting of the
American Pain Society in San Diego. The data presented from this
460-patient clinical study which evaluated RELISTOR for the
treatment of opioid-induced constipation (OIC) in patients with
chronic, non-cancer pain showed that significantly more patients
treated with RELISTOR had laxation within four hours after the
first dose compared with placebo. Results from this pivotal study
would be included in a planned supplemental New Drug Application to
the U.S. Food and Drug Administration. If approved for OIC in the
chronic pain setting, this would add a new indication for RELISTOR
in the United States. The positive outcome of this one-month,
blinded portion of the study was previously announced (See original
release at: www.progenics.com/releasedetail.cfm?ReleaseID=350881).
A copy of the poster presentation with more information on this
portion of the data is available at www.progenics.com. In addition,
data from the two-month, open-label phase of this study will be
presented at a future scientific meeting. Currently, RELISTOR is
approved for the treatment of OIC in patients with advanced illness
who are receiving palliative care, when response to laxative
therapy has not been sufficient.
�While opioids are often used to treat patients with chronic,
non-cancer pain, opioid-induced constipation can complicate their
use,� said lead author of the study, E. Richard Blonsky, M.D.,
Director of The Pain and Rehabilitation Clinic of Chicago and
Clinical Professor of Neurology at Northwestern University�s
Feinberg School of Medicine. �The results from this double-blind
study indicate that subcutaneous RELISTOR may be a promising
treatment option for this patient population.�
Study design and results: Co-primary end points
achieved
The phase 3 clinical trial examined the use of RELISTOR
subcutaneous injection as a treatment for OIC (less than three
bowel movements per week) in chronic, non-cancer pain patients,
including those with back pain, osteoarthritis, or fibromyalgia.
Four-hundred-sixty-nine patients were randomized to treatment, and
of these, 460 patients received RELISTOR or placebo, dosed daily
(QD) or every other day (QOD) for four weeks. Patients were
required to stop all laxative use prior to entering the clinical
study. Only the use of rescue laxatives was permitted during the
study.
The pivotal phase 3 study�s co-primary end points both met
statistical significance:
- Patients taking RELISTOR
experienced rescue-free bowel movements (RFBMs, or laxations)
within four hours of the first dose significantly more frequently
than those taking placebo (34.2% versus 9.9%, P
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