FDA Pharmaceutical Approval: Kapvay
FLORHAM PARK, N.J., Oct. 4 /PRNewswire/ -- Shionogi Inc., the U.S.-based group company of Shionogi & Co., Ltd., today announced the U.S. Food and Drug Administration approval of the non-stimulant medication KAPVAY™ (clonidine hydrochloride) extended-release tablets, an extended-release oral formulation for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents ages 6-17 years. KAPVAY™ is the only formulation of clonidine hydrochloride approved by the FDA for the treatment of ADHD, and is the first and only FDA-approved ADHD treatment indicated for use as add-on therapy to stimulant medication. KAPVAY™ can also be used as monotherapy when treating ADHD.
An oral, non-stimulant, twice-daily therapy, KAPVAY™ is a centrally acting alpha2-adrenergic receptor agonist. While the mechanism of action of alpha2 agonists in ADHD is not known, it is believed to involve the pre-frontal cortex (PFC) of the brain. Studies suggest that the PFC regulates attention and plays a critical role in impulse control, working memory and executive function.
"The FDA approval of KAPVAY™ represents an exciting milestone in the field of ADHD," said Donald C. Manning, MD, PhD, Chief Medical Officer of Shionogi Inc. "The extended-release formulation of KAPVAY™ minimizes the peaks and troughs in blood levels, thereby decreasing overactivation of the alpha receptors in the brain and periphery. We look forward to providing this important, beneficial treatment for ADHD to patients, both as monotherapy and add-on therapy to stimulants."
"ADHD is a complex disorder that requires individualized treatment. While there are prescription treatment options available, many ADHD patients on stimulants do not achieve adequate control of symptoms," explained Rakesh Jain, MD, MPH, Director of Psychiatric Drug Research for R/D Clinical Research at Lake Jackson, Texas, and an investigator in the clinical trials. "KAPVAY™, when added to a stimulant, addresses an unmet need, and improves ADHD symptoms beyond what is achieved by stimulants alone. This is a significant step forward for the treatment of ADHD to have an approved product for add-on therapy in our treatment armamentarium."
ADHD is a neurobehavioral disorder that occurs in childhood and may continue into adolescence and adulthood, which affects more than 4.5 million children ages 3-17 in the U.S. alone. Approximately 3-7 percent of U.S. school-aged children are believed to suffer from this disorder. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior, and hyperactivity/over-activity.
For more information on Kapvay or Shionogi, please visit the corporate website or Kapvay product website.
The New Quick Change Shoe
DR. SCHOLL'S has tackled one of woman's biggest modern day dilemmas: cute or comfortable? It's no secret that most fashionable shoes aren't suitable for wearing all day ... whether it's a on business trip or a girl's night out, we want to look our best but struggle with achy feet at the expense of our high heeled kicks.
A few weeks ago, "Merck Consumer Care announced the launch of DR. SCHOLL’S® FOR HER Fast Flats™, a stylish and practical solution for women who need a break from their uncomfortable shoes.
Fast Flats™ are compact and foldable shoes that fit discreetly in a purse and come with a wristlet for easy storage and portability. This spare pair is perfect for nights out, weddings, traveling through airports and other times when a long trek in heels won’t cut it. Women can even wear Fast Flats™ during their commute, and then slip in to their fashionable shoes just in time to hit the office."
According to Jay Morgan, vice president of Research and Development for DR. SCHOLL’S®, “While women love their stylish shoes, many feel they have to sacrifice comfort to wear them for an entire day or night. We know that’s not the case, and we wanted to give women a great solution for their feet. Fast Flats™ are fashionable and affordable, enabling women to be prepared for the many scenarios they face throughout the day without having to worry about shoe discomfort.”
As a woman who has spent countless hours in uncomfortable shoes at the sake of fashion, and as someone who has been naming new products for over a decade, I can appreciate both the uniqueness of this new offering, and the simpleness of the name. DR. SCHOLL'S could have taken a variety of directions when naming this new product, but they chose to be descriptive, and emphasize the ease of use and quick-change nature that women prefer. Fast Flats is set up to be a category definer (as illustrated by the current surge in knock-offs). The messaging of the name makes it easy to for the customer to understand the product and the benefit. Alliteration lends to memorability, and the two syllable name construction adds easy recall.
I'm excited to try my own pair. What do you think? Ready for a quick change?
FDA Pharmaceutical Approval: Suboxone
According to ClinicaSpace, MonoSol Rx, the developers of PharmFilm® technology and a drug delivery company specializing in film pharmaceutical products, today announced that its partner, Reckitt Benckiser Pharmaceuticals Inc., a wholly-owned subsidiary of Reckitt Benckiser Group plc (LSE: RB), has received approval from the U.S. Food and Drug Administration (FDA) to market Suboxone® (buprenorphine HCl/naloxone HCl dihydrate) sublingual film for the treatment of opioid dependence.
This is the second U.S. marketing authorization for a prescription product based on MonoSol Rx's PharmFilm® technology, closely following the July 2010 FDA approval of the anti-emetic Zuplenz® (ondansetron) oral soluble film.
Suboxone® sublingual film delivers a convenient, quick-dissolving therapeutic dose of buprenorphine, a partial opioid agonist, and naloxone, an opioid antagonist. The drugs rapidly absorb under the tongue to ensure compliance.
A. Mark Schobel, President and CEO of MonoSol Rx, stated, "We are very pleased to announce the approval of Suboxone® sublingual film and disclose our important relationship with Reckitt Benckiser. Following the FDA approvals of Suboxone® sublingual film and Zuplenz® oral soluble film, both within the past two months, the agency has clearly accepted our proprietary PharmFilm® technology as a viable prescription drug dosage form.
The 6th Food Group: Crayons
cray·on / [krey-on, -uhn]
–noun
1. a pointed stick or pencil of colored clay, chalk, wax, etc., used for drawing or coloring.
2. a drawing in crayons.
–verb (used with object)
3. to draw or color with a crayon or crayons.
–verb (used without object)
4. to make a drawing with crayons.
When I hear the word crayon, my mind immediately goes to the iconic art supply and the brand I grew up with ... the Crayola crayon and its magnificent box of 64 with a built-in sharpener. I remember holding them with little hands, learning how to use the different shades together, and even melting them for cool grade-school art projects.
So this new beverage line has me puzzled. You want me to 'drink crayons?' I've been taught all my life to keep the markers, paintbrushes and crayons out of mouth, and now there is an imperative to do so?
As a mom, I can appreciate the premise behind the beverage: a drink with no high fructose corn syrup, less sugar and more juice than leading drinks for kids. As a verbal branding associate, I see a great opportunity for a fun, new name that can appeal to kids in its tonality, and to moms in its approach to nutrition.
Using an arbitrary word for a brand can work, if it's executed well. Apple built its brand off ease and the approachability of something as simple as a piece of fruit. Is Crayons trying a similar approach? Capitalizing on our childhood nostalgia and hoping that translates into a mental shift? That now, it's ok to 'drink our crayons?'
As for kids, will this product be confusing in real-life scenarios? "Mom, can I have Crayons with dinner tonight?" Or, "Kate, you can drink these Crayons, but don't eat those in your art supplies." For some reason, I can't reconcile the idea of now consuming or drinking something that has been a part of my life for so long, and used in a very different way. What do you think? Are you ready to 'drink your crayons?'
FDA Pharmaceutical Approval: Glassia
Kamada Ltd. (KMDA.TA) received FDA Approval for AATD Drug Glassia.
According to the Alpha-1 Association, Alpha-1 Antitrypsin Deficiency (Alpha-1) is a condition that is passed on from parents to their children through genes. This condition may result in serious lung and/or liver disease at various ages in life.
Alpha-1 antitrypsin is a protein that is produced mostly in the liver. Its primary function is to protect the lungs from neutrophil elastase. Neutrophil elastase is an enzyme that normally serves a useful purpose in lung tissue-it digests damaged or aging cells and bacteria to promote healing. However, if left unchecked, it will also attack healthy lung tissue. Alpha-1 antitrypsin, in sufficient amounts, will trap and destroy neutrophil elastase before it has a chance to begin damaging the delicate lung tissue. Consequently, if an individual doesn't have enough alpha-1 antitrypsin, the enzyme goes unchecked and attacks the lung.
According to MarketWatch, David Tsur, Chief Executive Officer of Kamada said, "We are very proud with this achievement. This success belongs to each one of the company's employees. With this unique product, Kamada is able to offer the US Alpha-1 patients a new liquid, ready- to- use drug that may ease their therapy routine and provide an additional high quality product in the US market for the benefit of this community.
We are committed to the Alpha-1 patient community and take great pride in further developments of our second generation product, an inhaled Alpha- 1-Proteinase Inhibitor currently in stage 2-3 clinical development."
Visit MyGlassia.com for more information about this treatment.
For more information regarding Pharmaceutical Naming or Brand Development, contact Vince Budd at [email protected]
FDA Pharmaceutical Approval: Zuplenz
FDA Approves Strativa Pharmaceuticals' Zuplenz (ondansetron) Oral Soluble Film for the prevention of postoperative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting.
"The FDA approval of Zuplenz marks an important milestone for Strativa as it reinforces our commitment to enhancing prescription products to meet the different needs of patients," said John A. MacPhee, President, Strativa Pharmaceuticals. "Zuplenz offers an innovative and convenient, easy-to-take formulation for patients who have trouble swallowing tablets, while providing the trusted efficacy expected from ondansetron."
For more information regarding Pharmaceutical Naming or Brand Development, contact Vince Budd at [email protected]
An app by any other name is the same
According to The American Marketing Association (AMA), a brand is defined as a "name, term, sign, symbol or design, or a combination of them intended to identify the goods and services of one seller or group of sellers and to differentiate them from those of other sellers." Key word here = differentiation.
My job entails creating new identities for companies ... products, services, new corporations. In doing so I strive to create a moniker that stands out from the competition; a name that effectively positions the offering in a way that offers distinction and memorability.
So why is it that iPhone apps don't appear to operate under the same guidelines? I was searching for a calorie counter app the other day - type in anything related to calories, exercise or fitness and you are inundated with apps that promise to trim your waistline and increase your cardio stamina. Problem is, aside from the price and the star-based feedback, how do you tell them apart? At first glance alone, how do you differentiate?
Here are the results of my app search for 'calorie': Read more
And the American Graphic Design Award goes to ...
......................................................................................................................................................................
Kudos to our Visual Design Department who recently was recognized for four brands by American Graphic Design and Advertising.
Carnival Cruise Lines: Drainpipe logo
Carnival Cruise Lines: Twister logo
FUJIFILM Medical Systems: Synapse logo
PPG: VIVATI Collection logo
Kristin Everidge, Manager of Visual Branding for Addison Whitney, commented, "It has been an honor to be a part of ADGA’s annual awards for the past 12 years. The 2010 winners represent a synergy between the core competencies of our organization, which include naming and design work for these clients. Because of our iterative and collaborative processes with these clients, we share the credit for these awards with Carnival Cruise Lines, FUJIFILM and PPG."
Zoo Seeking Namers
The Louisville Zoo is seeking a name for the latest addition to its family: a baby boy giraffe. The zoo is taking submissions from now until April 25th, so get noodling on some cute entries for this little guy.
3/50 Project
Have you heard about the 3/50 project? As of March 10, 2010, this project reached 50,000 Facebook fans and over one million page views. So what is it?
Project 3/50 was founded by Cinda Baxter and built on the simple premise that to build a stronger economy, we need to inspire and thank consumers for their support of independent, locally owned businesses.
Pick 3. Spend 50. Save your local economy.
3: Think of three businesses you’d miss if they disappeared, then stop in. Say hello. Pick up a little something. That’s what keeps those businesses around.
50: If just half the employed U.S. population committed $50 of their current monthly spending to locally owned, independent brick and mortar businesses, those transactions would generate more than $42.6 billion annually. Imagine what would happen if 3/4 of the poplulation did that.
It's interesting to note that for for every $100 spent with local brick and mortars, more than $68 returns to the local economy; when spent with a chain or big box, $43 returns. If spent online, unless you live in the same community as the e-tailer, nothing comes home. In an era where we're glued to our computers and technology, and large superstores make it so easy and convenient to have our goods delivered to our doorstep, this figure hit home for me. Over half of the money stays in the community when you purchase locally. That's pretty impressive ... and is just one little way you can make a difference.
The organization is currently launching the "Eat Down the Street" Campaign, challenging individuals to eat at one locally owned, independent restaurant per week—no chains or national brands. Some of my favorite places are independently owned so this is a no-brainer for me.
For more information, check out The350Project.net.
What are specific things that you are doing to support your local economy and community?