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07-13-2007, 07:26 AM
I found this article and thought it would be an interesting read. Also in the bottom half there is a link to a website for pain trials. Here is to life with less pain soon! (Wish this was a new concept med not just a redo...)
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Patient Recruitment Completed for Pivotal Phase III Study of Remoxy
From the PharmaLive.com News Archive - Jul. 11, 2007
Clinical Results Expected Q4 2007
SOUTH SAN FRANCISCO, Calif. and BRISTOL, Tenn., July 11, 2007 (PRIME NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) and King Pharmaceuticals, Inc. (NYSE:KG) announced today they have reached the enrollment target of 400 patients for a Phase III study with Remoxy(tm). Remoxy, an investigational drug, is a proprietary abuse-deterrent version of long-acting oxycodone, a strong opioid painkiller.
This randomized, double-blinded, placebo-controlled study enrolled patients in the U.S. with moderate-to-severe osteoarthritic pain. Following a titration period, patients were randomized to either twice-daily Remoxy (10-80 mg daily) or placebo for 12 weeks. The primary endpoint is change in pain scores during the treatment period. Top line results of this study are expected in Q4 2007, after the last patient completes the three-month treatment period.
This Remoxy study is being conducted under the auspices of a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA). The SPA specifies the Phase III trial objective, design, clinical endpoints and statistical analyses needed to support FDA approval. These features are considered binding, i.e., the FDA will not later alter its perspective unless public health concerns unrecognized at the time of protocol assessment are evident. Under the SPA, one successful Phase III study is required to file a New Drug Application for Remoxy.
About Remoxy
Remoxy, an investigational drug, is an abuse-deterrent version of long-acting oxycodone, a strong opioid painkiller. It is intended to meet the needs of physicians or pharmacists who appropriately prescribe or dispense long-acting opioids and who seek to minimize risks of diversion, abuse or misuse. Pain Therapeutics and King Pharmaceuticals have a strategic alliance in place to develop and commercialize Remoxy and other abuse-deterrent opioids. Remoxy's formulation includes Oradur(tm) technology licensed from Durect Corporation (Nasdaq:DRRX).
About Oxycodone Abuse
Please visit the U.S. Drug Enforcement Administration's website for more information: www.deadiversion.usdoj.gov/drugs_concern/oxycodone/oxycodone.htm.
About Pain Therapeutics, Inc.
Pain Therapeutics develops novel drugs for pain management and hematology/oncology. The Company has four investigational drug candidates in clinical programs, including Remoxy, Oxytrex(tm), PTI-202 and a novel radio-labeled monoclonal antibody to treat metastatic melanoma. The FDA has not yet evaluated the merits, safety or efficacy of our drug candidates. For more information, please visit www.paintrials.com.
About King Pharmaceuticals, Inc.
King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products in attractive markets and the strategic acquisition of branded products that can benefit from focused promotion and marketing and product life-cycle management.
-0- CONTACT: Pain Therapeutics, Inc. Christi Waarich, Senior Manager of Investor Relations 650-825-3324 cwaarich@paintrials.com
King Pharmaceuticals, Inc. James E. Green, Executive Vice President, Corporate Affairs 423-989-8125 David E. Robinson, Senior Director, Corporate Affairs 423-989-7045
Burns McClellan Media Carney Noensie 212-213-0006
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Patient Recruitment Completed for Pivotal Phase III Study of Remoxy
From the PharmaLive.com News Archive - Jul. 11, 2007
Clinical Results Expected Q4 2007
SOUTH SAN FRANCISCO, Calif. and BRISTOL, Tenn., July 11, 2007 (PRIME NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) and King Pharmaceuticals, Inc. (NYSE:KG) announced today they have reached the enrollment target of 400 patients for a Phase III study with Remoxy(tm). Remoxy, an investigational drug, is a proprietary abuse-deterrent version of long-acting oxycodone, a strong opioid painkiller.
This randomized, double-blinded, placebo-controlled study enrolled patients in the U.S. with moderate-to-severe osteoarthritic pain. Following a titration period, patients were randomized to either twice-daily Remoxy (10-80 mg daily) or placebo for 12 weeks. The primary endpoint is change in pain scores during the treatment period. Top line results of this study are expected in Q4 2007, after the last patient completes the three-month treatment period.
This Remoxy study is being conducted under the auspices of a Special Protocol Assessment (SPA) from the U.S. Food and Drug Administration (FDA). The SPA specifies the Phase III trial objective, design, clinical endpoints and statistical analyses needed to support FDA approval. These features are considered binding, i.e., the FDA will not later alter its perspective unless public health concerns unrecognized at the time of protocol assessment are evident. Under the SPA, one successful Phase III study is required to file a New Drug Application for Remoxy.
About Remoxy
Remoxy, an investigational drug, is an abuse-deterrent version of long-acting oxycodone, a strong opioid painkiller. It is intended to meet the needs of physicians or pharmacists who appropriately prescribe or dispense long-acting opioids and who seek to minimize risks of diversion, abuse or misuse. Pain Therapeutics and King Pharmaceuticals have a strategic alliance in place to develop and commercialize Remoxy and other abuse-deterrent opioids. Remoxy's formulation includes Oradur(tm) technology licensed from Durect Corporation (Nasdaq:DRRX).
About Oxycodone Abuse
Please visit the U.S. Drug Enforcement Administration's website for more information: www.deadiversion.usdoj.gov/drugs_concern/oxycodone/oxycodone.htm.
About Pain Therapeutics, Inc.
Pain Therapeutics develops novel drugs for pain management and hematology/oncology. The Company has four investigational drug candidates in clinical programs, including Remoxy, Oxytrex(tm), PTI-202 and a novel radio-labeled monoclonal antibody to treat metastatic melanoma. The FDA has not yet evaluated the merits, safety or efficacy of our drug candidates. For more information, please visit www.paintrials.com.
About King Pharmaceuticals, Inc.
King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products in attractive markets and the strategic acquisition of branded products that can benefit from focused promotion and marketing and product life-cycle management.
-0- CONTACT: Pain Therapeutics, Inc. Christi Waarich, Senior Manager of Investor Relations 650-825-3324 cwaarich@paintrials.com
King Pharmaceuticals, Inc. James E. Green, Executive Vice President, Corporate Affairs 423-989-8125 David E. Robinson, Senior Director, Corporate Affairs 423-989-7045
Burns McClellan Media Carney Noensie 212-213-0006