REMOXY New Drug Application Accepted By FDA
SAN MATEO, Calif., Jan. 27, 2011 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) resubmission for REMOXY ® (controlled-release oxycodone) and has classified it as a Class 2 resubmission.
With the Class 2 designation, the FDA has set a corresponding Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2011.
REMOXY is a twice daily, long-acting formulation of oral oxycodone for moderate to severe pain requiring continuous, around-the-clock opioid treatment for an extended period of time. This investigational drug candidate was developed to help address the growing problem of non-medical use of prescription opioids. REMOXY is designed to provide steady, around-the-clock pain relief, while resisting common methods of tampering intended to result in the rapid release of oxycodone. REMOXY is a unique formulation of the patented ORADUR ™ technology licensed from Durect Corporation (Nasdaq:DRRX).REMOXY ® is a registered trademark of Pain Therapeutics. About Pain Therapeutics, Inc. Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. In addition to REMOXY, the Company has three other drug candidates in clinical programs. These include a novel monoclonal antibody-based treatment against metastatic melanoma. The Company is also developing a new treatment for patients with hemophilia, a genetic disorder in which patients are unable to stop bleeding. For more information, please see www.paintrials.com Forward-Looking Statements This press release contains forward–looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "Act"). When used in this press release, the words "intend", "expect", "believe" and similar expressions are intended to identify forward–looking statements. Examples of forward–looking statements in this press release include statements concerning, among other items, Company's expectations regarding the timing of the FDA's review of the REMOXY NDA; the potential benefits of REMOXY; and the growth of non-medical use of prescription opioids. The Company disclaims 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. 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 regulatory approval of REMOXY; unexpected adverse side effects or inadequate therapeutic efficacy of the REMOXY; the uncertainty of patent protection for the Company's intellectual property or trade secrets; the potential for abuse resistant pain medications to be developed by competitors and potential competitors to the Company. For further information regarding these and other risks related to the Company's business, investors should consult the Company's filings with the Securities and Exchange Commission.
CONTACT: Judy Ishida Administrative Manager Pain Therapeutics, Inc. IR@paintrials.com 650-645-1924
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