Nexafed extended release found bioequivalent to Sudafed 12-hour tablets
PALATINE, Ill. — Acura Pharmaceuticals on Monday announced preliminary results from a pilot clinical study which demonstrated bioequivalence of one formulation of Nexafed extended-release tablets to Sudafed 12-hour tablets. Nexafed extended-release tablets utilize Acura's Impede 2.0 enhanced methamphetamine-resistant technology. Acura intends to request a pre-investigational new drug meeting with the Food and Drug Administration to review this data and discuss a complete development program.
"These study results validate our ability to move our Impede technology into extended-release formulations," stated Al Brzeczko, Acura's VP technical affairs. "Demonstrating bioequivalence with one formulation this early in our development process allows us to more rapidly advance to discussions with FDA to determine our full development program for this product."
The study was conducted in 12 fasted, healthy subjects and measured the systemic absorption of the active ingredient, pseudoephedrine, from a single dose each of two experimental Nexafed extended-release formulations compared to Sudafed 12-Hour tablets. Nexafed formulation B met FDA's standards for bioequivalence for maximum plasma concentration and extent of absorption. Nexafed formulation A met the bioequivalence criteria for extent of absorption but was low for maximum plasma concentration.
Walgreens Boots Alliance, WebMD to speak at 2015 Lions Health Conference
LONDON — Experts from international retail pharmacy organization Walgreens Boots Alliance and multinational health, hygiene and home products company Reckitt Benckiser have been confirmed as speakers for the upcoming Lions Health conference in Cannes, France in June.
During the WebMD session at the Festival, Alex Gourlay, EVP Walgreens Boots Alliance, and president of Walgreens, will join WebMD CEO David Schlanger to examine what it will take for consumers to incorporate the necessary behavior changes they need to make to improve their health, Lion's Health announced. And Ukonwa Ojo, the global brand director and head of global brand equity for Durex and KY at Reckitt Benckiser, will take to the stage to explore how leveraging popular culture has transformed Durex from the world's No. 1 condom brand to the world's top sexual wellbeing brand.
"It's a privilege to be able to bring world-class talent like this to the stage at Lions Health," said Louise Benson, festival director for Lions Health. "After our launch year, we've been working closely with the industry to create an exciting new festival programme that truly delivers on both learning and inspiration."
Launching a new format, Lions Health will offer four streams of content focusing on "Creative Inspiration," "The Big Issues," "Creative Tools and Innovation," as well as interactive "Knowledge Huddles," focusing on some of healthcare's most pressing topics and exciting developments.
In exploring changing health care and "The Big Issues," one of the key themes under discussion will be the realm of digital and specific areas within this.
David Blair, head of industry for health at Google, will address innovation and behavior change. "The velocity of connected life continues at a torrid pace and nowhere is this being felt more than in healthcare," Blair said. "I'll be using the seminar to dive deep into behavior-changing digital experiences and technological innovations, which are now a fundamental part of the industry."
Lions Health is a global annual awards for creative excellence in pharma and healthcare and wellness communications, judged by international industry professionals. The awards form part of a two-day Festival of content, learning and debate that will explore the essential and unique issues relating to the world of healthcare communications, present exhibitions and screenings of the work being judged and offer networking opportunities. Lions Health 2015 will be held June 19 and 20, Palais des Festivals, Cannes, France.
Omron’s Alvita Wireless Tracker boasts Bluetooth Smart technology
LAKE FOREST, Ill. — Omron Healthcare on Wednesday announced the new Alvita Wireless Activity Tracker, a great tool to help keep people motivated to maintain their fitness goals.
Omron’s most advanced tracker yet, the Alvita Wireless Activity Tracker (HJ-327T), is petite yet powerful. It allows the user to transfer fitness data wirelessly to their smartphone with the free Omron Fitness App. Featuring Bluetooth Smart technology, the Alvita Wireless Tracker records steps, aerobic steps, distance and calories burned so users can set realistic goals and check progress along the way.
“Good things come in small packages, and our new wireless activity tracker in our popular Alvita line is no exception,” said Jill Person, product marketing manager, fitness, Omron Healthcare. “While it is our smallest tracker yet, it boasts powerful, leading-edge technology that delivers accurate information to help users turn data into healthy lifestyle decisions.”
Measuring less than 1 sq. in. and sporting a fresh light green color with optional detachable clip, the Alvita Wireless Activity Tracker uses Tri-Axis technology for accuracy so it can be worn almost anywhere, such as at the hip, in a pocket or tucked inside a purse.
It is compatible with systems and devices — including iPhone 4S and higher, iPad 3 and higher, iOS 7+, Samsung Galaxy S III and higher and Android OS 4.3+ — when the free Omron Fitness mobile app is installed. The tracker displays the current day’s activity on a clear LCD screen with the tap of a finger, and stores up to 14 days in the device.
The Alvita Wireless Activity Tracker is available at the Omron Online Store, and will soonbe available at Walgreens and Amazon; the Alvita Tracker distribution will expand to more brick-and-mortar and online retailers in the coming months. The suggested retail price is $59.99. A bulk version also is available in blue for institutions, clinical studies and corporations.
Users also can set up a free account at Omron’s companion website, OmronWellness.com, where they can download and share fitness activity, send data to Walgreens Balance Rewards, get a snapshot of overall health from their personal dashboard and participate in fitness and health challenges. OmronWellness.com also allows users to connect compatible Omron blood pressure monitors for individuals interested in tracking their blood-pressure readings in addition to fitness.
“Your wellbeing can be a bit of a numbers game, so we’ve designed smart tools that offer a clearer picture of your health,” Person said. “Our users are already active, but now they can be pro-active about their fitness goals and achievements by leveraging technology.”
Loading Post Please Wait...