Pain Therapeutics Announces Feedback from Recent Meeting with FDA on REMOXY
February 05 2019 - 8:00AM
Pain Therapeutics, Inc. (Nasdaq: PTIE), a clinical-stage drug
development company, today announced feedback from a meeting held
January 31, 2019 with the U.S. Food and Drug Administration (FDA)
regarding the drug candidate, REMOXY ER. REMOXY is the trade
name for a new type of abuse-deterrent, extended-release gel
formulation of oxycodone (CII) with physical/chemical properties
intended to deter abuse. As previously disclosed, we
requested this meeting to resolve disagreement around comments and
conclusions made by FDA in 2018 during a regulatory review of a New
Drug Application (NDA) for REMOXY.
During this meeting, we learned that i) FDA
denies making math errors, material mistakes or misrepresentations
during a June 2018 Advisory Committee Meeting for REMOXY,
despite clear evidence to the contrary; ii) comparator data is
irrelevant for the evaluation of abuse-deterrent properties,
despite FDA written guidance which explicitly states the opposite;
and (ii) that we would need to rely on the Freedom of Information
Act to access additional data generated by FDA with REMOXY.
As a result of our recent meeting with FDA, we believe we are no
closer today to product approval than we were over a year ago.
“REMOXY remains an odyssey without a
homecoming,” said Remi Barbier, President & CEO of Pain
Therapeutics. “We had hoped for a fair, neutral and impartial
review of the REMOXY data. Instead, we walked out of this meeting
feeling a bit disoriented by FDA’s lack of transparency, clarity or
helpfulness. It’s a rare occasion when two parties can’t
agree on simple math. We can’t work with shambolic
regulations. This is not how you win support for
innovation.”
Historically, the lead candidate in our pipeline
has been REMOXY, an analgesic drug that we conceived, patented,
developed and tested in collaboration with corporate and academic
partners. Over the years, we have conducted a successful
clinical development program for REMOXY, including a large,
well-controlled pivotal Phase III efficacy study whose primary
endpoints met statistical significance (p<0.05). The
clinical safety or analgesic efficacy of REMOXY for its intended
purpose is not in question. Its abuse-deterrent properties,
however, are subject of a difference of opinion. Abuse
deterrence refers to properties that are embedded into an opioid
formulation to prevent certain common methods of abuse. During the
long development history of REMOXY, we generated nearly 9,000
unique data points in over 50 studies at a cost in excess of $100
million. Studies were designed in consultation with FDA and
conducted by independent labs. Collectively, we believe these
studies adequately characterize REMOXY’s abuse-deterrent
properties. In particular, we demonstrated that the two currently
marketed extended-release oxycodone products -- OxyContin® and
Xtampza® -- which both benefit from abuse-deterrent label claims,
can both be defeated for purposes of abuse in under a minute using
common household items. In contrast, REMOXY requires a
significant investment of time, effort and equipment to defeat, and
even then, results in less release of oxycodone. During our
recent meeting with FDA we were informed they believe REMOXY
capsules lack abuse deterrence via the injection route of abuse
because “oxycodone can be extracted from the product”, regardless
of how much time, effort, frustration or equipment is required to
so do. We are unable to follow the logic by which a drug product
should never release drug. More generally, as the regulatory
requirements for REMOXY have changed frequently and suddenly over
time, we have experienced significant delays and have incurred
unanticipated expenses related to the overall REMOXY development
program. -more-We believe innovative products such as REMOXY can
serve a meaningful social purpose and, potentially, may save lives
during the worst drug crisis in American history. By
necessity, however, we rely on reasonably predictive regulatory
pathways to guide our product candidates through development in
preparation for commercialization. We also rely on principles
of good governance, in which similar drugs receive similar
regulatory treatment under rules that are clear, publicized, and
evenly applied. In our experience with REMOXY, the regulatory
environment around abuse-deterrence lacks these essential
qualities.
There are procedures in place at the FDA and
other government agencies to help promote a fair resolution of
disputes. Such procedures can be complex and may not be
rapid, predictable or even viable. Going forward, we will
generally be silent regarding our plans or future expectations for
REMOXY, unless a significant material event occurs that compels us
to update our public disclosures around this product candidate.
About Pain
Therapeutics, Inc.Pain Therapeutics, Inc. is a
clinical-stage biopharmaceutical company that develops novel
drugs. Our focus is on neurodegeneration, including an
on-going Phase II program with our drug candidate, PTI-125, in
patients with Alzheimer’s disease. We own worldwide
development and commercial rights to PTI-125 and related
technology, including diagnostic, without royalty or milestone
obligations to any third-parties. The FDA has not yet
established the safety or efficacy of any of our drug
candidates. For more information, please visit
www.paintrials.com.
For More Information Contact:Eric SchoenChief
Financial OfficerPain Therapeutics, Inc.(512) 501-2450
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 clinical
status of PTI-125 and the Company’s future plans, if any, for its
abuse-deterrent product candidates, such as 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 the ability to
demonstrate the specificity, safety, efficacy or potential health
benefits of a blood-based diagnostic. 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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