AUSTIN, Texas, Aug. 06, 2018 (GLOBE NEWSWIRE) — Pain Therapeutics, Inc. (Nasdaq: PTIE) today announced it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Remoxy, an abuse-deterrent, extended-release form of oxycodone. According to FDA, “The data submitted in [the] NDA do not support the conclusion that the benefits of [Remoxy] Extended-Release Capsules outweigh the risks.”
About Pain Therapeutics, Inc.
We develop proprietary drugs that offer significant improvements to patients and physicians. We generally focus our drug development efforts around disorders of the nervous system. The FDA has not yet established the safety or efficacy of our drug candidates.
Note Regarding Forward-Looking Statements: This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Pain Therapeutics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, statements regarding the future of Remoxy following the FDA’s issuance of another Complete Response Letter; the reorganization of the Company’s resources, and the timing of public announcements regarding such reorganization; and the potential benefits of the Company’s program in Alzheimer’s disease. 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 our financial and operational ability to carry out development activities around Alzheimer’s disease. For further information regarding these and other risks related to our business, investors should consult our filings with the U.S. Securities and Exchange Commission.
Source: Pain Therapeutics, Inc.
Posted: August 2018
- Pain Therapeutics Announces Results of FDA Advisory Committee Meeting for Remoxy ER – June 26, 2018
- 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
- Pain Therapeutics and King Pharmaceuticals Announce Submission of
New Drug Application for Remoxy – June 10, 2008
Remoxy ER (oxycodone) FDA Approval History
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