QRxPharma initiates key Phase 3 Study of MoxDuo™IR for moderate to severe acute pain
QRxPharma (ASX: QRX and OTCQX: QRXPY) announced today, as part of its Phase 3 program, the initiation of a registration (also called pivotal) trial (Study 008) comparing 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.
The Company expects to complete dosing by close of Q2 2010.
Managing director Dr John Holaday said “We recently reported clinical studies demonstrating the superiority of MoxDuo™IR in terms of tolerability compared to equi-analgesic doses of morphine, oxycodone and Percocet® for the management of acute post-operative pain."
"These studies demonstrated that MoxDuo™IR provides significant pain relief and fewer side effects (nausea, vomiting, dizziness and constipation),” he said.
“We are now addressing a regulatory requirement for New Drug Application (NDA) approval of MoxDuo™IR, i.e., demonstration that it is superior in efficacy to its individual components.”
A double-blind study with about 35 patients per group, completed earlier this year in patients with pain following bunionectomy surgery, demonstrated the superiority of MoxDuo 12 mg/8 mg relative to 12 mg morphine and to 8 mg oxycodone.
The purpose of the current Phase 3 registration study (008) is to replicate these differences in a larger trial, one with sufficient statistical power to achieve significance on the primary and secondary endpoints.
If successful, this trial will satisfy the “Combination Rule” requirement of the US Food and Drug Administration (FDA) and will also serve as a registration study.
final Phase 3 registration trial (Study 009: a double-blind controlled study to evaluate the effectiveness of MoxDuo™IR in patients following total knee replacement surgery) is scheduled to begin Q1 2010.
No additional pharmacology, toxicology or long-term clinical safety studies will be required for regulatory submission and market approval. QRxPharma expects to complete its Phase 3 program Q3 2010 and file its NDA for MoxDuo™IR by EOY 2010.
QRx shares rose on the news, touching $0.83 before easing back to $0.80.
QRxPharma is a clinical-stage specialty pharmaceutical company focused on the development and commercialisation of therapies for pain management and central nervous system (CNS) disorders.
Register here to be notified of future Australia Market Wrap articles.
Other Australia Market Wrap articles
-
09/02/10 Western Uranium one to watch in manganese exploration in 2010
-
09/02/10 China factor at work on metals markets
-
09/02/10 Indaba delegates hear certain metals prices heading for the roof
-
09/02/10 The recent sell-off in gold could mean the correction is nearly complete
-
08/02/10 Oil Prices Fall Sharply as General Market Sells Off
-
08/02/10 Potash is a fertile ground to buy into
-
08/02/10 UBS forecasts explosion in copper prices
-
08/02/10 Silver stocks smashed and bloodied
-
05/02/10 Australian shares slide 2.8%
-
05/02/10 Demand for rare earths up
Other Australia Market Wrap news
-
09/02/10 Global Iron acquires African Petroleum in $500 million deal
-
09/02/10 Miners optimistic about Chinese iron ore price talks
-
08/02/10 Korean govt strikes lithium deal with Posco
-
08/02/10 China iron-ore price talks reportedly to conclude by April 1
-
05/02/10 Molybdenum listed on LME
-
04/02/10 Gold Anomaly makes potential gold vein discovery at Sao Chico
-
03/02/10 Pent up demand gobbles gold stocks
-
02/02/10 China consolidates as world No. 1 gold producer with new record production
-
29/01/10 Bhushan Steel increases loan facility for Bowen Energy
-
29/01/10 Tananmi Gold to acquire Newmont's Groundrush Gold Project