FDA BACKS QRX PLAN FOR TWO PHASE III DUAL-OPIOD TRIALS
August 8th 2008 07:11
Tuesday August 5, 2008
Daily news on ASX-listed biotechnology companies
* ASX, BIOTECHS DOWN: CYTOPIA UP 15%, ANTISENSE DOWN 13%
* FDA BACKS QRX PLAN FOR TWO PHASE III TRIALS
* ANTISENSE: ATL1102 ACTION DIFFERENT FROM TYSABRI
* BIOGUIDE BRIEF: PML AND ANTISENSE RISK; CEO RESPONSE
* HEARTWARE TO VOTE ON REDOMICILE TO THE US
* CHEMGENEX APPOINTS JEAN-LUC TÉTARD DIRECTOR
* FEDERAL GOVERNMENT WELCOMES CRC REVIEW RECOMMENDATIONS
* GAVIN JENNINGS, DR TERRY CUTLER OPEN INNOVATION CONFERENCE
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QRX PHARMA
QRX Pharma says the US Food and Drug Administration has accepted its phase III protocol designs and analyses to demonstrate the efficacy and safety of Q8003IR.
QRX said Q80031R was an immediate release dual-opioid combining morphine and oxycodone intended for the management of moderate to severe acute pain.
Pending incorporation of the FDA’s recommended modifications, “only two phase III trials will be required” for an investigational new drug application, the company said.
“Under this streamlined clinical development program, no additional pharmacology, toxicology or long-term clinical safety studies will be required for regulatory submission and market approval,” QRX said.
QRX chief executive officer Dr John Holaday said the decision was “a significant and positive outcome”.
“Acceptance of QRX Pharma’s streamlined development plan for Q8003IR is a measure of success in terms of reduced risk, resource efficiencies and potential value of dual opioids,” Dr Holaday said.
Following an FDA meeting on July 21, 2008, the company reported the FDA had determined no new animal safety studies were needed, accepted the design of the proposed combination rule study with minimal modifications and found the proposed number of patients receiving Q8003IR, as well as the duration of dosing, sufficient for regulatory submission of a 505(b)2 NDA.
A phase III dose-ranging trial was completed in April (see Biotech Daily; May 5 and 22 2008).
Final phase III studies for Q8003IR will include a combination rule study in patients experiencing post-bunionectomy pain and placebo-controlled study in patients following total knee replacement. The trials are due to begin by the end of the year.
QRX was unchanged at 60 cents.
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