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Pain Therapeutics Announces Update on Drug Portfolio

Conference Call Tomorrow, Tuesday, at 4:30 p.m. Eastern Time

AUSTIN, Texas, May 11, 2015 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc., (Nasdaq:PTIE) today announced an update regarding its portfolio of drug candidates. After staying quiet for the past six months, management expects an uptick in news flow for the rest of 2015. Expected milestones include a clear path to the FDA for re-filing the REMOXY NDA, announcement of proof-of-concept results for an abuse deterrent transdermal pain patch and announcement of non-dilutive funding for a new drug development initiative in a major indication.

"We've substantially completed the transition of REMOXY from our previous corporate partner," said Remi Barbier, President and CEO of Pain Therapeutics. "We believe the data we've seen absolutely supports re-filing the REMOXY NDA. We expect to do so in Q1 2016."

REMOXY® Update

General Comments

Results of Clinical and Non-Clinical Studies

Regulatory Strategy

Manufacturing and Supply Chain Strategy

Marketing and Commercialization Strategy


The pharmacokinetics of oxycodone and its metabolites following single oral doses of REMOXY®, an abuse-deterrent formulation of extended-release oxycodone, in patients with hepatic or renal impairment.

by Bimal K Malhotra, PhD; Grant L. Schoenhard, PhD2; Annelies W. de Kater2, PhD; Nadav Friedmann2, PhD, MD.

1 March/April 2015; Volume 11, Number 2, pages 157-169
2 Pain Therapeutics employee or consultant.




Pain Therapeutics will host a conference call on Tuesday, May 12th at 4:30 pm Eastern Time to discuss progress across its portfolio of drug candidates and to respond to questions.

To participate in the conference call, please dial 1-877-407-4018 prior to the start of the call. Those interested in listening to the conference call live via the internet may do so by visiting the Company's website at

A playback of the call will be available for about 7 days after the live event. To access the playback, please dial toll free 1-877-870-5176 (or international toll-free number 1-858-384-5517) and enter code 1360-9974.


We own world-wide commercial rights to our lead drug candidate, REMOXY Extended-Release Capsules CII, which is a unique, twice-a-day formulation of oral oxycodone. REMOXY's intended indication is for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time and for which alternative treatments are inadequate. We specifically developed REMOXY to discourage certain common methods of drug tampering and misuse. The REMOXY NDA is supported by multiple clinical trials, including a successful Phase III efficacy program conducted under a Special Protocol Assessment.

About Pain Therapeutics, Inc.

Pain Therapeutics, Inc. is a clinical-stage biopharmaceutical company that develops novel drugs. The FDA has not approved our drug candidates for commercial sale.  For more information, please visit

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 potential resubmission of an NDA for REMOXY with the U.S. Food and Drug Administration, or FDA, and the timing of such resubmission; proposed non-clinical studies with respect to REMOXY; the sufficiency of data and other information to support the resubmission and approval of an NDA for REMOXY; potential commercialization strategies for REMOXY; intended sources of commercial supply for REMOXY; the size and scope of target markets for REMOXY, FENROCK and our unannounced pre-clinical drug candidate; the timing of announcement of pre-clinical data for FENROCK; the announcement, including announcement timing, of a new pre-clinical drug candidate; potential arrangements, and the timing for announcement, for non-dilutive funding with respect to our unannounced pre-clinical drug candidate; and statements regarding the benefits of our 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, difficulties or delays in development, testing, regulatory approval, production and marketing of our drug candidates, including REMOXY and FENROCK; unexpected delays in the submission and regulatory review of a proposed NDA for REMOXY; unexpected adverse side-effects or inadequate therapeutic efficacy of our drug candidates and other factors that could slow or prevent, development, product approval or market acceptance (including the risk that current and past results of clinical trials may be found to be insufficient for marketing approval and the risk that current and past results of clinical trials and non-clinical studies may insufficient to support continued development); developments of products or technologies by current or future competitors; the development of competing or alternative therapies, and difficulties or delays in obtaining non-dilutive sources of funding.

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.

CONTACT: Peter S. Roddy

         Vice President and Chief Financial Officer

         Pain Therapeutics, Inc.


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