QRxPharma Releases Additional Pivotal Phase 3 Combination Rule Study Data for MoxDuo IR in Patients with Post-Surgical Pain
Data Demonstrate Dual-Opioid(TM) Provides Significantly Better Pain Relief Compared to Component Doses; Study Goals and Secondary Endpoints Met
BEDMINSTER, N.J. and SYDNEY, Australia, May 4 /PRNewswire/ --
QRxPharma announced today the release of additional pivotal Phase 3
trial data for MoxDuo IR, an immediate-release Dual-Opioid pain
therapy. Required for New Drug Application (NDA) submission with
the United States Food and Drug Administration (FDA), this
"combination rule" study compared the efficacy and safety profiles
of MoxDuo IR against component doses of morphine and oxycodone
alone for the management of moderate to severe post-operative pain
following bunionectomy surgery. MoxDuo IR not only demonstrated
statistically superior analgesic effect compared to component doses
of morphine (p=0.01) and oxycodone (p=0.01) but, also, a favorable
side effect profile despite delivering twice the opioid dose of its
individual components. The trial enrolled 522 patients at 6 US
clinical research sites. Primary and secondary endpoints were
met.
"While the initial trial data demonstrated the superiority of
MoxDuo IR in terms of analgesic effect, further analysis revealed
equally important findings in terms of superior overall pain
relief, reduced reliance on supplemental analgesia and strong
tolerability," said Dr. John Holaday, Managing Director and Chief
Executive Officer, QRxPharma. "These findings are consistent with
earlier comparative data and reinforce both the clinical benefit
and commercial potential of MoxDuo IR - our lead Dual-Opioid
product candidate."
The primary endpoint for evaluating the efficacy of MoxDuo IR 12
mg/8 mg versus its milligram components (morphine 12 mg and
oxycodone 8 mg) was the difference in pain intensity scores from
baseline for each patient over the 48-hour treatment period
(SPID48).
Secondary endpoints included: (1) efficacy relating to the
amount of supplemental analgesic (ibuprofen) used throughout the
treatment period; (2) difference in pain intensity scores from
baseline for each patient over the first 24-hour treatment period
(SPID24); and (3) safety as measured by incidence and intensity of
opioid-related adverse effects.
In terms of supplemental analgesia, patients in the morphine and
oxycodone control groups were 2-3 times more likely to use
ibuprofen supplemental dosing than those receiving MoxDuo IR
(p<0.05 to p<0.01). Control groups were also more likely to
use ibuprofen in greater amounts and earlier in the treatment
period than patients receiving MoxDuo IR (p<0.01 to p<0.001).
Even with the extra use of rescue medication in the control groups,
at both 24 and 48 hours, the amount of pain reduction from baseline
was significantly less compared to patients receiving MoxDuo IR
(p<0.05 to p<0.001).
The enhanced tolerability of MoxDuo IR seen in earlier studies
was further validated in this pivotal Phase 3 combination rule
trial. Whilst patients in the MoxDuo IR (12/8mg) arm received twice
the morphine equivalent dose of patients in the other two
comparator arms (morphine 12 mg or oxycodone 8mg), the incidence
and intensity of moderate to severe side effects remains similar
whilst efficacy was higher with MoxDuo IR. This tolerability is
further evidenced by the 93% to 95% patient completion rate in the
study treatment groups.
"By delivering twice the opioid dose, one would expect a
substantial increase in both the incidence and intensity of a broad
range of side effects, but that is not the case with MoxDuo IR,"
added Holaday. "Our Dual-Opioid(TM) formulation provides improved
pain relief and greater tolerability as each drug component acts on
different receptors. This means we can enhance analgesia without
significantly increasing side effects."
Among all groups, the most common moderate to severe adverse
events were CNS (i.e. dizziness, somnolence, etc.) with an
incidence range of 10% to 15%; gastrointestinal (i.e. nausea,
emesis, etc.) with an incidence range of 15% to 30%; and
dermatological (i.e. itchiness, skin rash, etc.) with an incidence
range of 2% to 6%. The percentage of patients in the MoxDuo IR
group who reported moderate to severe vomiting was less than seen
in previous studies and this was the only side effect that occurred
more frequently with MoxDuo IR than its half-dose components.
"Having satisfied the combination rule requirement, we now turn
our attention to the second and final MoxDuo IR registration trial,
a study to evaluate the effectiveness of MoxDuo IR in patients
following total knee replacement surgery, which was initiated in
February 2010 and projected to complete dosing in Q3 2010," said
Holaday.
Forward Looking Statements
This release contains forward-looking statements.
Forward-looking statements are statements that are not historical
facts; they include statements about our beliefs and expectations.
Any statement in this release that states our intentions, beliefs,
expectations or predictions (and the assumptions underlying them)
is a forward-looking statement. These statements are based on
plans, estimates and projections as they are currently available to
the management of QRxPharma. Forward-looking statements therefore
speak only as of the date they are made, and we undertake no
obligation to update publicly any of them in light of new
information or future events.
By their very nature, forward-looking statements involve risks
and uncertainties. A number of important factors could therefore
cause actual results to differ materially from those contained in
any forward-looking statement. Such factors include risks relating
to the stage of products under development; uncertainties relating
to clinical trials; dependence on third parties; future capital
needs; and risks relating to the commercialization of the Company's
proposed products.
About QRxPharma
QRxPharma is a clinical-stage specialty pharmaceutical company
focused on the development and commercialization of new treatments
for pain management and central nervous system (CNS) disorders.
Based on a development strategy which focuses on enhancing and
expanding the clinical utility of currently marketed compounds, the
Company's product portfolio includes both late and early stage
clinical drug candidates with the potential for reduced risk,
abbreviated development paths, and improved patient outcomes. The
Company intends to directly commercialize its products in the US
and seek strategic partnerships for worldwide markets. QRxPharma's
lead product candidate, MoxDuo®IR, is in Phase 3 clinical
development and has successfully completed multiple comparative
studies evaluating its efficacy and safety against equianalgesic
doses of morphine, oxycodone and Percocet® for the treatment of
acute pain. Data collected from these studies provided additional
guidance for optimizing the design and initiation of two pivotal
Phase 3 studies required for New Drug Application (NDA) filings
with the US Food and Drug Administration (FDA). QRxPharma expects
to complete its Phase 3 program Q3 CY2010 and file its NDA for
MoxDuo®IR in Q4 CY2010. The Company's preclinical and clinical
pipeline includes other technologies in the fields of pain
management, neurodegenerative disease and venomics. For more
information, visit www.qrxpharma.com.
Source: QRxPharma
CONTACT: Alicia Moran, +1-410-991-7027, Alicia@brightlinemedia.com,
for
QRxPharma
Web Site: http://www.qrxpharma.com/
Posted: May 2010
