Remoxy ERTreatment for Pain
NDA Submitted for Remoxy
Pain Therapeutics and King Pharmaceuticals Announce Submission of New Drug Application for Remoxy
SAN MATEO, Calif. and BRISTOL, Tenn. , June 10, 2008 – Pain Therapeutics, Inc. and King Pharmaceuticals, Inc. today announced that a New Drug Application (NDA) for Remoxy has been submitted to the U.S. Food and Drug Administration (FDA). Remoxy, a unique long-acting formulation of oral oxycodone for moderate to severe chronic pain, is designed to resist common methods of prescription drug misuse and abuse.
Pain Therapeutics and King believe the NDA for Remoxy benefits from years of rigorous and independent scientific and clinical testing. The NDA includes animal and human data from extractability, pharmacokinetic, toxicology and clinical studies. If approved, the Companies believe Remoxy could be the first oxycodone on the market that is designed to reduce the risk of misuse and abuse.
"Our vision is to develop a line of opioid painkillers that minimizes the risk of misuse, abuse or diversion," said Remi Barbier, Pain Therapeutics' chairman, president and chief executive officer. "We believe the integrity of such drugs can deliver peace of mind to physicians, pharmacists and patients."
Brian A. Markison, King’s chairman, president and chief executive officer, stated, "The NDA submission for Remoxy is an important advance in meeting the pain management needs of patients and prescribers concerned with addressing the risks of prescription pain medicine misuse and abuse within our communities."
About the NDA for Remoxy
Pain Therapeutics submitted the NDA in accordance with the FDA’s Electronic Common Technical Document specifications. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, the FDA is expected to determine whether to accept the NDA for filing within 90 days. At that time the Companies will also learn if the NDA filing was granted priority review. A Priority Review designation is given to drugs that offer real advances in treatment, or provide a treatment where no adequate therapy exists. A Priority Review means that the time it takes FDA to review a NDA is reduced from 12 months to approximately 6 months.
About the Development Program for Remoxy
The development program for Remoxy consists of several clinical studies, including one pivotal Phase III study conducted under a Special Protocol Assessment (SPA), which evaluated the safety and efficacy of Remoxy in over 400 patients with osteoarthritis. With a SPA, the study design, endpoints and statistical analyses needed to support approval were agreed upon by the FDA prior to initiating the study and are considered binding. The Companies believe that the SPA for Remoxy remains in full-force without modification. The following summarizes the pivotal Phase III results:
- Pursuant to the SPA, the primary endpoint of the Remoxy pivotal Phase III study was defined as mean decrease in pain intensity scores between Remoxy and placebo during the 12-week treatment period.
- The study achieved a statistically significant result in its primary endpoint (p<0.01).
- In addition, the study achieved statistically significant results in secondary endpoints such as Quality of Analgesia (p<0.01) and Global Assessment (p<0.01).
About Oxycodone Abuse
Approximately 50 million Americans suffer with chronic pain, a distinct type of pain, often with no cure. It can affect an individual throughout his or her life, lasting several weeks, months, or even years at a time. The onset of chronic pain may be nociceptive (caused by ongoing tissue injury), neuropathic (caused by damage to the brain, spinal cord, or peripheral nerves), or disease specific (such as osteoarthritis or cancer).
About the Alliance Between Pain Therapeutics, Inc. and King Pharmaceuticals, Inc.
Pain Therapeutics and King Pharmaceuticals entered into a strategic alliance to develop and commercialize Remoxy and other opioid painkillers designed to deter common methods of abuse. Pain Therapeutics is substantially responsible for drug formulation, clinical development and regulatory filings for Remoxy and the other opioid painkillers developed under this alliance. King has responsibility to exclusively commercialize Remoxy and the other opioid drugs that are part of the alliance. Remoxy and other opioid painkillers developed under this alliance are unique formulations of the patented Oradur technology licensed from Durect Corporation.
About Pain Therapeutics, Inc.
Pain Therapeutics is a biopharmaceutical company that develops novel drugs. In addition to Remoxy, the Company has three drug candidates in clinical programs, including PTI-202, Oxytrex and a novel radio-labeled monoclonal antibody to treat metastatic melanoma. Pain Therapeutics is also working on a new treatment for patients with hemophilia. The FDA has not yet evaluated the merits, safety or efficacy of the Company’s 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.
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Pain Therapeutics, Inc. and King Pharmaceuticals, Inc. disclaim any intent or obligation to update these forward-looking statements, and claim the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, any statements relating to the acceptance, priority review or approval of the NDA for Remoxy by the FDA and the potential benefits of the companies’ drug candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Companies’ drug candidates, unexpected delays in the acceptance or review of Companies’ filing of a NDA for Remoxy by the FDA, and unexpected adverse side-effects or inadequate therapeutic efficacy of the Companies’ drug candidates that could slow or prevent product approval or market acceptance (including the risk that current and past results of clinical trials are not necessarily indicative of future results of clinical trials). For further information regarding these and other risks related to the Companies’ business, investors should consult the Companies’ respective filings with the U.S. Securities and Exchange Commission.
Posted: June 2008
- FDA Accepts Remoxy NDA For Review - March 1, 2018
- Pain Therapeutics Resubmits New Drug Application for Remoxy ER, an Abuse-Deterrent, Extended-Release Drug Candidate for the Treatment of Chronic Pain - February 13, 2018
- Pain Therapeutics Receives Complete Response Letter for Remoxy ER - September 26, 2016
- FDA Accepts Remoxy NDA for Review - April 12, 2016
- Pain Therapeutics Resubmits Remoxy New Drug Application to the U.S. Food and Drug Administration - March 29, 2016
- Pfizer to Discontinue Agreement on Remoxy (oxycodone) Extended-Release Capsules CII - October 27, 2014
- FDA Complete Response Letter Received for Remoxy - June 24, 2011
- Remoxy New Drug Application Accepted by the FDA with PDUFA Goal Date of June 23, 2011 - January 27, 2011
- King Pharmaceuticals and Pain Therapeutics Announce Resubmission of New Drug Application for Remoxy - December 27, 2010
- Pain Therapeutics Receives Complete Response Letter From FDA for Remoxy - December 11, 2008