Welcome!

News Feed Item

New Research Highlights an Investigational Single-Entity Formulation Hydrocodone Bitartrate Extended-Release Tablet at PAINWeek

STAMFORD, Conn., Sept. 4, 2014 /PRNewswire/ -- Purdue Pharma is presenting results from several studies and post-hoc analyses evaluating extended-release, single-entity hydrocodone bitartrate tablets, including the analgesic effectiveness and safety among patients transitioning from immediate-release hydrocodone combination products and the formulation's abuse-deterrent potential  in recreational opioid abusers at PAINWeek national conference Sept. 2 – 6 in Las Vegas.

Purdue Pharma, L.P. logo.

Purdue Pharma's investigational pain medication, once-daily hydrocodone bitartrate (which is expected to be marketed under the trade name, Hysingla™ ER) is a single-entity product that does not include acetaminophen.  The tablets are formulated with abuse-deterrent properties designed to make the product more difficult to manipulate for the purpose of misuse or abuse by various routes of administration (e.g., chewing, snorting and intravenous injection).

Highlights of three of the several posters presented this week are as follows:

  • One poster, titled "Evaluation of once-daily hydrocodone (Hysingla™ ER) in users of immediate-release hydrocodone combination products," analyzed the analgesic effectiveness and safety of single-entity hydrocodone (Hysingla ER) in 20 mg to 120 mg tablets dosed once daily among patients with moderate to severe chronic pain and who were transitioning from hydrocodone  products that are combined with acetaminophen.  Data were from two phase 3 studies: a 12-week, placebo-controlled, double-blind study, and an open-label, long-term study with a 12-month maintenance treatment period. Among these patients in the placebo-controlled study, Hysingla ER (N=62) showed clinically meaningful and statistically significant pain relief at week 12 compared to placebo (N=67) in both primary and sensitivity analyses (deltas=0.64 to 0.98; P's = .0078 to .0357). Among patients in the long-term study, clinically significant improvements from baseline in pain relief (e.g., 30% reduction in pain) were achieved with Hysingla ER treatment, and these treatment effects were maintained throughout 12-month treatment period. Among patients who had previously used hydrocodone/acetaminophen products, adverse events were consistent with those associated with opioid analgesics. The most common treatment-emergent adverse events included constipation, nausea, vomiting, dizziness, and headache.
  • The next study, which is the first of two studies being presented on abuse potential, titled "Intranasal Abuse Potential Study of a Once-Daily, Single-Entity, Extended-Release Hydrocodone Tablet (Hysingla™ ER) in Recreational Opioid Users," compared the intranasal abuse potential of fine-milled and coarse-milled Hysingla ER (using an industrial mill and razor blade, respectively) to that of hydrocodone powder and placebo. Abuse potential was evaluated using pharmacokinetic measures of plasma samples and subjective pharmacodynamic measures of drug liking.
    • The pharmacokinetic data showed that subjects had a higher concentration of hydrocodone in the blood following hydrocodone powder than they did following use of either fine-milled or coarse-milled Hysingla.
    • The pharmacodynamic assessment showed that mean scores for overall drug liking were highest for hydrocodone powder followed by the two tampered Hysingla ER treatments and placebo. Compared with hydrocodone powder:
      • 68 percent of subjects using coarse-milled Hysingla ER had a reduction of at least 30 percent in drug liking where 64 percent had a reduction of at least 50 percent, and 44 percent had a reduction of at least 90 percent.
      • 72 percent of subjects using fine-milled Hysingla ER had a reduction of at least 30 percent in drug liking where 64 percent had a reduction of at least 50 percent, and 36 percent had a reduction of at least 90 percent.
  • The second of the two abuse-potential studies presented, titled "Oral Abuse Potential Study of a Once-Daily, Single-Entity, Extended-Release Hydrocodone Tablet (Hysingla™ ER) in Recreational Opioid Users," compared the oral abuse potential of Hysingla ER when chewed or when milled with an industrial mill to that of the intact Hysingla ER, immediate release hydrocodone solution and placebo. Abuse potential was evaluated using pharmacokinetic measures of plasma samples and subjective pharmacodynamic measures of drug liking.
    • The pharmacokinetic results showed higher concentrations of hydrocodone among subjects using immediate release hydrocodone solution than subjects using milled, chewed or intact Hysingla ER, and the  time to achieve maximum concentration was faster among subjects using hydrocodone IR than those using milled, chewed or intact Hysingla ER
    • The pharmacodynamic assessments showed that mean scores for overall drug liking were highest for hydrocodone IR solution and milled Hysingla ER. Compared to the hydrocodone IR solution:
      • 83 percent of subjects using intact Hysingla ER had a reduction of at least 30 percent in drug liking where 74 percent had a reduction of at least 50 percent, and 37 percent had a reduction of at least 90 percent.
      • 69 percent of subjects using chewed Hysingla ER had a reduction of at least 30 percent in drug liking where 60 percent had a reduction of at least 50 percent, and 29 percent had a reduction of at least 90 percent.
      • 17 percent of subjects using milled Hysingla ER had a reduction of at least 30 percent in drug liking where 9 percent had a reduction of at least 50 percent, and 6 percent had a reduction of at least 90 percent.

"These studies continue to support the fact that, if approved by the Food and Drug Administration, Hysingla ER could be an important alternative for healthcare professionals treating patients in chronic pain with a hydrocodone product formulated with physicochemical properties intended to deter abuse," said Todd Baumgartner, M.D., MPH, Vice President of Research & Development and Chief Medical Officer at Purdue Pharma which funded the research.

The opioid hydrocodone in combination with acetaminophen (Vicodin® and its generic formulations) is the most commonly prescribed opioid analgesics in the United States.1 However, acetaminophen may cause liver toxicity (i.e., hepatotoxicity), including serious liver failure, when a patient exceeds the total recommended dosage of less than 4g per day,2 prompting the need for an extended release option without acetaminophen.

Immediate release hydrocodone combination products are also the most widely abused (nonmedical use) according to the Substance Abuse and Mental Health Services Administration.3 Currently available hydrocodone formulations do not incorporate abuse-deterrent technologies. 

The U.S. Food and Drug Administration (FDA) recently granted Priority Review designation to Purdue's new drug application requesting approval to market Hysingla ER, which incorporates abuse-deterrent properties.

About Chronic Pain
Purdue is a leader in developing treatment options for the management of chronic pain, which is one of the most common reasons for visits to healthcare professionals. Chronic pain conditions affect more than 100 million U.S. adults and cost the American economy as much as $635 billion each year in direct healthcare expenses and lost productivity.

About Purdue Pharma L.P.
Purdue Pharma L.P. and its associated U.S. companies are privately-held pharmaceutical companies known for pioneering research on chronic pain. Headquartered in Stamford, CT, Purdue is engaged in the research, development, production, and distribution of both prescription and over-the-counter medicines and hospital products. Additional information about Purdue can be found at www.purduepharma.com.

1 U.S. Pharmaceutical Sales - Q4 2013, Drugs.com, Accessed 09/04/2014
2 Ferguson E, Nelson L. 2009. Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM179888.pdf. Accessed 09/04/14.
3 2012 National Household Survey on Drug Use and Health, Table 1.89A, Substance Abuse and Mental Health Services Administration.  Accessed 09/04/2014

Logo - http://photos.prnewswire.com/prnh/20100921/NY67262

SOURCE Purdue Pharma L.P.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
"This week we're really focusing on scalability, asset preservation and how do you back up to the cloud and in the cloud with object storage, which is really a new way of attacking dealing with your file, your blocked data, where you put it and how you access it," stated Jeff Greenwald, Senior Director of Market Development at HGST, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...
SYS-CON Events announced today that Catchpoint Systems, Inc., a provider of innovative web and infrastructure monitoring solutions, has been named “Silver Sponsor” of SYS-CON's DevOps Summit at 18th Cloud Expo New York, which will take place June 7-9, 2016, at the Javits Center in New York City, NY. Catchpoint is a leading Digital Performance Analytics company that provides unparalleled insight into customer-critical services to help consistently deliver an amazing customer experience. Designed ...
WebRTC services have already permeated corporate communications in the form of videoconferencing solutions. However, WebRTC has the potential of going beyond and catalyzing a new class of services providing more than calls with capabilities such as mass-scale real-time media broadcasting, enriched and augmented video, person-to-machine and machine-to-machine communications. In his session at @ThingsExpo, Luis Lopez, CEO of Kurento, introduced the technologies required for implementing these idea...
"A lot of times people will come to us and have a very diverse set of requirements or very customized need and we'll help them to implement it in a fashion that you can't just buy off of the shelf," explained Nick Rose, CTO of Enzu, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
Buzzword alert: Microservices and IoT at a DevOps conference? What could possibly go wrong? In this Power Panel at DevOps Summit, moderated by Jason Bloomberg, the leading expert on architecting agility for the enterprise and president of Intellyx, panelists peeled away the buzz and discuss the important architectural principles behind implementing IoT solutions for the enterprise. As remote IoT devices and sensors become increasingly intelligent, they become part of our distributed cloud enviro...
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and containers together help companies achieve their business goals faster and more effectively. In his session at DevOps Summit, Ruslan Synytsky, CEO and Co-founder of Jelastic, reviewed the current landscape of Dev...
The WebRTC Summit New York, to be held June 6-8, 2017, at the Javits Center in New York City, NY, announces that its Call for Papers is now open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 20th International Cloud Expo and @ThingsExpo. WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web co...
For basic one-to-one voice or video calling solutions, WebRTC has proven to be a very powerful technology. Although WebRTC’s core functionality is to provide secure, real-time p2p media streaming, leveraging native platform features and server-side components brings up new communication capabilities for web and native mobile applications, allowing for advanced multi-user use cases such as video broadcasting, conferencing, and media recording.
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
"Plutora provides release and testing environment capabilities to the enterprise," explained Dalibor Siroky, Director and Co-founder of Plutora, in this SYS-CON.tv interview at @DevOpsSummit, held June 9-11, 2015, at the Javits Center in New York City.
DevOps tends to focus on the relationship between Dev and Ops, putting an emphasis on the ops and application infrastructure. But that’s changing with microservices architectures. In her session at DevOps Summit, Lori MacVittie, Evangelist for F5 Networks, will focus on how microservices are changing the underlying architectures needed to scale, secure and deliver applications based on highly distributed (micro) services and why that means an expansion into “the network” for DevOps.
SYS-CON Events announced today that Enzu will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Enzu’s mission is to be the leading provider of enterprise cloud solutions worldwide. Enzu enables online businesses to use its IT infrastructure to their competitive ad...
"We are an all-flash array storage provider but our focus has been on VM-aware storage specifically for virtualized applications," stated Dhiraj Sehgal of Tintri in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Choosing the right cloud for your workloads is a balancing act that can cost your organization time, money and aggravation - unless you get it right the first time. Economics, speed, performance, accessibility, administrative needs and security all play a vital role in dictating your approach to the cloud. Without knowing the right questions to ask, you could wind up paying for capacity you'll never need or underestimating the resources required to run your applications.