AUSTIN, Texas, Sept. 26, 2014 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE), a drug development company, today announced it has expanded its pipeline with the addition of FENROCK, an early-stage drug candidate. FENROCK is a transdermal (skin) patch that contains fentanyl, a strong opioid drug typically used to manage severe cancer pain. Fentanyl is also abused for its intense euphoric effects, and overdose can be fatal. FENROCK is specifically designed to prevent recreational abuse of fentanyl. The U.S. market for currently marketed fentanyl patches is believed to be around $900 million.
“We continue to believe our lead drug candidate, REMOXY, is on-track for an NDA re-filing in mid-2015 by Pfizer,” said Remi Barbier, Chairman, President & CEO of Pain Therapeutics. “FENROCK expands our pipeline and is consistent with our strategy to eventually develop drugs in four major categories of pain management: mild, moderate, moderate-severe and severe pain. There is no change to our financial guidance for 2014, as FENROCK’s development costs are already reflected in our projected cash use of about $12 million in 2014.”
Pain Therapeutics will discuss FENROCK at the 2014 BioCentury NewsMakers in the Biotech Industry Conference being held today, Friday, September 26th, at 9:30 a.m. Eastern Time at the Millennium Broadway Hotel Conference Center in New York City.
Those interested in listening to the presentation live via the internet may do so by visiting the Company’s website at www.paintrials.com. A replay of the presentation will be available on the website for approximately two weeks following the presentation.
About FENROCK™
FENROCK is a new, proprietary abuse-deterrent pain patch in pre-IND stage of development. Our goal with FENROCK is to mitigate the abuse, misuse, overdose and death associated with currently marketed fentanyl patches. The active drug ingredient in the FENROCK patch is fentanyl (CII), a highly potent synthetic opioid typically used to manage severe cancer pain. Currently marketed fentanyl patches can be abused by those who seek an intense euphoric high. Being 100X more potent than morphine, fentanyl is also one of the deadliest drugs of abuse. FENROCK is designed to provide pain relief over 72 hours when used appropriately but to block the euphoric effects of fentanyl under conditions of abuse or accidental misuse. We developed FENROCK in-house in collaboration with outside scientific experts. We own all product rights worldwide without royalty, milestone or other economic obligations to any third-party.
About REMOXY ™
Our lead drug candidate is called REMOXY (oxycodone) Extended-Release Capsules CII. REMOXY is an oral formulation of oxycodone for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. We designed REMOXY to discourage common methods of tampering and abuse. Pfizer, Inc. (NYSE:PFE) is our exclusive, worldwide commercial partner for REMOXY, except as to Australia/New Zealand.
About Pain Therapeutics, Inc.
Pain Therapeutics, Inc. is a biopharmaceutical company that develops novel drugs. The FDA has not approved any of our drug candidates for commercial sale. For more information, please visit www.paintrials.com.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about our prospects for growth, intellectual property protection, market size or growth, competitive position, regulatory agency action, and the anticipated development, timing, data readouts and therapeutic scope and value of our development stage products. You should not place undue reliance on these statements. These statements involve significant risks and uncertainties. Our results may differ materially from those contained in such statements, including, among others: our inability to protect our intellectual property rights and to have sufficient rights to commercialize our products; product competition; clinical trials of our products may fail or not initiated or conducted in a timely manner; our products may show insufficient therapeutic effects or unacceptable safety profiles; adverse decisions by regulatory authorities; existing preclinical and clinical data with respect to our products may not be indicative of future clinical or commercial results; unfavorable market launch of our product by Pfizer; reimbursement for our products; and the inability to manufacture successfully our products. Additional factors that could cause actual results to differ significantly from those projected in our forward-looking statements are discussed in our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and recent Current Reports on Form 8-K. Our forward-looking statements are based on our current beliefs and expectations and speak only as of the date of this presentation. We do not undertake any obligation to update any forward-looking statements. The term “Abuse-deterrent” as used in this presentation 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. Oxycodone and fentanyl are controlled-substances (CII) with high potential for abuse. The active ingredient in all opioids (including REMOXY and FENROCK) are highly addictive.
CONTACT: For More Information Contact: Peter S. Roddy Vice President and Chief Financial Officer Pain Therapeutics, Inc. proddy@paintrials.com (512) 501-2450 Barbara Ryan FTI Consulting Barbara.ryan@fticonsulting.com (212) 850-5679
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