- REMOXY vs. Oxycodone ER Tested in Volunteers with History of Opioid Abuse -
- Drug Liking Significantly Lower for REMOXY (p<0.05) vs. Oxycodone ER -
- Time to Peak Drug Liking Significantly Delayed (p<0.05) vs. Oxycodone ER -
SAN MATEO, Calif., April 25, 2011 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) announced today top-line results of an abuse liability study with REMOXY®, an investigational drug for the treatment of pain. In the study, REMOXY met all prospectively defined primary endpoints. Full study results were recently published in Pain Medicine, the Official Journal of the American Academy of Pain Medicine. The principal investigator on this study, Lynn R. Webster, MD, has authored over 100 scientific abstracts and is medical director of Lifetree Clinical Research.
Pain Therapeutics developed REMOXY to help address the problem of prescription drug abuse. REMOXY is an encapsulated, water insoluble, highly viscous, twice-daily oral formulation of oxycodone. It is designed to provide steady pain relief, while resisting common methods of abuse that result in 'dose-dumping', or the rapid, premature release of a large dose of oxycodone.
Pfizer, Inc. (NYSE:PFE) is Pain Therapeutics' exclusive commercial partner for REMOXY and three other abuse-resistant prescription pain medications. A New Drug Application (NDA) for REMOXY is currently under regulatory review, with a target PDUFA date of June 23, 2011.
"Abuse potential studies provide a means to anticipate the likelihood of abuse of a drug before exposure to the general population," commented Lynn R. Webster, MD, principal investigator on this study. "I believe today's study results confirm that REMOXY is associated with a reduced potential for abuse. Further analysis in the real world will confirm if this reduced abuse potential translates to lower rates of actual abuse and misuse."
"The Abuse Potential of Remoxy, an Extended-Release Formulation of Oxycodone, Compared with Immediate and Extended-Release Oxycodone", (Pain Medicine 2011; vol 12(4);618-631)
Study Objective
The study was designed to evaluate the abuse potential of REMOXY relative to oxycodone extended-release (ER), oxycodone immediate release (IR) and placebo.
Study Design
This was a double blind, placebo and active-controlled, six-way crossover study. The study enrolled 45 healthy adult volunteers with histories of non-dependent recreational opioid use, defined as having recreationally abused opioids to achieve a euphoric high on at least five occasions in the previous 12 months, and at least once in the 90 days before screening visits. The study assessed the abuse potential of Remoxy 40 mg whole and chewed, oxycodone ER 40 mg whole and crushed, oxycodone IR 40 mg crushed and placebo. Treatments were administered in-clinic under various fed/fast conditions that produced the highest bioavailability for each drug (i.e., REMOXY in the fed state and oxycodone in the fasted state).
Study Results
The primary endpoint was Drug Liking, as assessed by various pharmacodynamic parameters. Thirty-two subjects were included in the endpoint analyses. In this study:
• Drug Liking was significantly lower (p<0.05) for REMOXY 40mg (whole) compared with oxycodone ER 40mg (whole) or oxycodone IR 40 mg.
• Drug Liking was significantly lower (p<0.05) for REMOXY 40mg (chewed) compared with oxycodone ER 40mg (crushed) or oxycodone IR 40 mg.
Time to Peak Drug Liking was significantly delayed (p<0.05) for REMOXY 40mg (chewed) compared with oxycodone ER 40mg (crushed) or oxycodone IR.
Secondary endpoints included Drug High and Good Effects, chewing duration, taste/texture assessments and safety assessments. These secondary endpoints generally demonstrated the same consistency of effects observed in the primary endpoints.
In addition, no subject could chew REMOXY for more than 1.5 minutes (mean = 48 seconds) despite an allotted time of 10 minutes, due to the unpleasant taste/texture of REMOXY.
Study results will also be presented at the American Pain Society Annual Scientific Meeting, May 19-21, in Austin, Texas. The poster abstract for this presentation is available on-line:
http://www.ampainsoc.org/abstract/2011/view/4771/?sms_ss=email&at_xt=4db1b3025fc5af8c%2C0
About Pain Therapeutics, Inc.
Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. In addition to REMOXY, we have three drug candidates in clinical programs, including abuse-resistant formulations of hydromorphone, hydrocodone and oxymorphone. We are also developing a monoclonal antibody to treat metastatic melanoma and are working on a new treatment for patients with hemophilia, a genetic disorder in which patients are unable to stop bleeding.
For more information, please visit www.paintrials.com.
REMOXY® is a registered trademark of Pain Therapeutics, Inc.
The FDA has not approved any of our drug candidates for commercial sale.
The term "abuse-resistant" as used in this announcement is not intended to designate an indication or a medical claim but rather a general description of agents designed to address the misuse, abuse and diversion of opioids.
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, any statements relating to the completion of the regulatory review and approval of REMOXY and the potential abuse reduction benefits of REMOXY. 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 and pursuit of regulatory approval of our drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of our drug candidates, failure of our products, if any are approved, in gaining market acceptance (including due to lessened realization of abuse resistance benefits than might have been indicated from prior testing or due to competing products and therapies being introduced by others) and the uncertainty of patent protection for our intellectual property or trade secrets. For further information regarding these and other risks related to our business, investors should consult our filings with the Securities and Exchange Commission.