|By PR Newswire||
|September 4, 2014 04:00 PM EDT||
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'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
SOURCE Purdue Pharma L.P.
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm.
Mar. 27, 2017 12:45 AM EDT Reads: 1,990
What sort of WebRTC based applications can we expect to see over the next year and beyond? One way to predict development trends is to see what sorts of applications startups are building. In his session at @ThingsExpo, Arin Sime, founder of WebRTC.ventures, will discuss the current and likely future trends in WebRTC application development based on real requests for custom applications from real customers, as well as other public sources of information,
Mar. 27, 2017 12:30 AM EDT Reads: 818
China Unicom exhibit at the 19th International Cloud Expo, which took place at the Santa Clara Convention Center in Santa Clara, CA, in November 2016. China United Network Communications Group Co. Ltd ("China Unicom") was officially established in 2009 on the basis of the merger of former China Netcom and former China Unicom. China Unicom mainly operates a full range of telecommunications services including mobile broadband (GSM, WCDMA, LTE FDD, TD-LTE), fixed-line broadband, ICT, data communica...
Mar. 27, 2017 12:00 AM EDT Reads: 3,316
My team embarked on building a data lake for our sales and marketing data to better understand customer journeys. This required building a hybrid data pipeline to connect our cloud CRM with the new Hadoop Data Lake. One challenge is that IT was not in a position to provide support until we proved value and marketing did not have the experience, so we embarked on the journey ourselves within the product marketing team for our line of business within Progress. In his session at @BigDataExpo, Sum...
Mar. 26, 2017 11:15 PM EDT Reads: 2,866
As software becomes more and more complex, we, as software developers, have been splitting up our code into smaller and smaller components. This is also true for the environment in which we run our code: going from bare metal, to VMs to the modern-day Cloud Native world of containers, schedulers and micro services. While we have figured out how to run containerized applications in the cloud using schedulers, we've yet to come up with a good solution to bridge the gap between getting your contain...
Mar. 26, 2017 09:45 PM EDT Reads: 7,558
With the introduction of IoT and Smart Living in every aspect of our lives, one question has become relevant: What are the security implications? To answer this, first we have to look and explore the security models of the technologies that IoT is founded upon. In his session at @ThingsExpo, Nevi Kaja, a Research Engineer at Ford Motor Company, will discuss some of the security challenges of the IoT infrastructure and relate how these aspects impact Smart Living. The material will be delivered i...
Mar. 26, 2017 09:45 PM EDT Reads: 2,033
Apache Hadoop is emerging as a distributed platform for handling large and fast incoming streams of data. Predictive maintenance, supply chain optimization, and Internet-of-Things analysis are examples where Hadoop provides the scalable storage, processing, and analytics platform to gain meaningful insights from granular data that is typically only valuable from a large-scale, aggregate view. One architecture useful for capturing and analyzing streaming data is the Lambda Architecture, represent...
Mar. 26, 2017 08:30 PM EDT Reads: 6,114
As organizations realize the scope of the Internet of Things, gaining key insights from Big Data, through the use of advanced analytics, becomes crucial. However, IoT also creates the need for petabyte scale storage of data from millions of devices. A new type of Storage is required which seamlessly integrates robust data analytics with massive scale. These storage systems will act as “smart systems” provide in-place analytics that speed discovery and enable businesses to quickly derive meaningf...
Mar. 26, 2017 07:45 PM EDT Reads: 9,586
Your homes and cars can be automated and self-serviced. Why can't your storage? From simply asking questions to analyze and troubleshoot your infrastructure, to provisioning storage with snapshots, recovery and replication, your wildest sci-fi dream has come true. In his session at @DevOpsSummit at 20th Cloud Expo, Dan Florea, Director of Product Management at Tintri, will provide a ChatOps demo where you can talk to your storage and manage it from anywhere, through Slack and similar services ...
Mar. 26, 2017 06:45 PM EDT Reads: 4,258
SYS-CON Events announced today that Ocean9will 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. Ocean9 provides cloud services for Backup, Disaster Recovery (DRaaS) and instant Innovation, and redefines enterprise infrastructure with its cloud native subscription offerings for mission critical SAP workloads.
Mar. 26, 2017 06:30 PM EDT Reads: 2,044
The taxi industry never saw Uber coming. Startups are a threat to incumbents like never before, and a major enabler for startups is that they are instantly “cloud ready.” If innovation moves at the pace of IT, then your company is in trouble. Why? Because your data center will not keep up with frenetic pace AWS, Microsoft and Google are rolling out new capabilities In his session at 20th Cloud Expo, Don Browning, VP of Cloud Architecture at Turner, will posit that disruption is inevitable for c...
Mar. 26, 2017 05:00 PM EDT Reads: 2,135
Building a cross-cloud operational model can be a daunting task. Per-cloud silos are not the answer, but neither is a fully generic abstraction plane that strips out capabilities unique to a particular provider. In his session at 20th Cloud Expo, Chris Wolf, VP & Chief Technology Officer, Global Field & Industry at VMware, will discuss how successful organizations approach cloud operations and management, with insights into where operations should be centralized and when it’s best to decentraliz...
Mar. 26, 2017 05:00 PM EDT Reads: 3,590
Providing the needed data for application development and testing is a huge headache for most organizations. The problems are often the same across companies - speed, quality, cost, and control. Provisioning data can take days or weeks, every time a refresh is required. Using dummy data leads to quality problems. Creating physical copies of large data sets and sending them to distributed teams of developers eats up expensive storage and bandwidth resources. And, all of these copies proliferating...
Mar. 26, 2017 03:30 PM EDT Reads: 6,522
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm. In his Day 3 Keynote at 20th Cloud Expo, Chris Brown, a Solutions Marketing Manager at Nutanix, will explore t...
Mar. 26, 2017 03:15 PM EDT Reads: 2,803
DevOps has often been described in terms of CAMS: Culture, Automation, Measuring, Sharing. While we’ve seen a lot of focus on the “A” and even on the “M”, there are very few examples of why the “C" is equally important in the DevOps equation. In her session at @DevOps Summit, Lori MacVittie, of F5 Networks, explored HTTP/1 and HTTP/2 along with Microservices to illustrate why a collaborative culture between Dev, Ops, and the Network is critical to ensuring success.
Mar. 26, 2017 03:00 PM EDT Reads: 10,540