Pain Therapeutics Announces Two New Peer-Reviewed Publications for REMOXY
REMOXY is the trade name for a new type of abuse-deterrent, twice-daily capsule gel formulation of oxycodone. REMOXY has physical/chemical properties intended to deter abuse.
“For years, opioid drugs were heavily marketed, inappropriately prescribed and lightly regulated, creating ideal conditions for an opioid epidemic,” said
The first publication is titled “
The second publication is titled “A Nasal Abuse Potential Randomized Clinical Trial of REMOXY ER, a High-Viscosity Extended-Release Oxycodone Formulation” and examined nasal abuse. The publication concludes that REMOXY ER demonstrated significantly lower nasal abuse potential compared to oxycodone immediate-release or OxyContin ER. Specifically, intranasal REMOXY ER led to four-fold lower peak levels of drug (Cmax); a 57-128% longer time to peak levels of drug (Tmax); a >10-fold lower ‘Abuse Quotient’; and lower ‘Take Drug Again’ scores compared to both OxyContin ER and oxycodone IR.
Data from both studies were included in the New Drug Application (NDA) for REMOXY.
Despite these robust data, and a total of over 8,800 meaningful data points, in
- Based on a fair, neutral and impartial review of data, there is overwhelming evidence that REMOXY may be less abusable than marketed extended-release oxycodone products;
- When corrected for math errors, material mistakes and misrepresentations made by
FDAduring a June 2018Advisory Committee Meeting, REMOXY has properties that may deter against common methods of abuse, such as injection abuse; and
- REMOXY meets all evidentiary standards for drug approval and its proposed indication.
For these and other reasons,
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 potential abuse-deterrent properties of REMOXY and the drug candidate’s overall risk/benefit profile. 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 potential regulatory approval of opioid drugs. 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.
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Chief Financial Officer
Source: Pain Therapeutics, Inc.