Archive for August, 2010

Aug 31 2010

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.

No responses yet

Aug 25 2010

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?’

2 responses so far

Aug 18 2010

Paint Scheming

My latest obsession: virtually painting my fingernails on OPI using their vast palette of audacious hues.

Why don plain old red when you could rock Tasmanian Devil Made Me Do It? You could scrap a shade of red altogether and try Who the Shrek are you? Or, you could really splurge with Extravagance. Hard Candy makes seductive shades like Mr. Right, Mr. Wrong, Hypnotic and Frenzy.

On my own personal fascination scale, that activity is followed closely by this game.

Why paint your walls a basic blue when you could coat them with a Fragrant Cloud or take an Aegean Cruise or dip into an Inky Pool? Why brown when Labrador Sands is an option? Or, how about Enigma from Sherwin-Williams? Valspar’s Ancestral Haze?

The verbal branding of these types of products is challenging (seriously, how does one delineate between I Think Pink and Pink-a-Doodle?), but it is clearly a powerful tool. Color naming takes advantage of the subjectivity and emotional responses of customers. These names help to paint a picture (no pun intended, I promise) for the consumer; they are buying not just a can of paint, not just a bottle of nail polish, but an entire experience created from a single shade. These special names make the customer part of a secret, a little wink-wink in an up close and personal world.

Perhaps you would like more than just warmth for your family room; try Buttered Toffee. If you wanted, you could turn your cabin den into a rustic getaway with help from Wild Frontier. Maybe your sunroom could be accented by Pool Party.

Did I recently have Mrs. O’Leary’s BBQ brushed on my toes? Why, yes. Yes, I did. Because for me, summertime isn’t just about the vibrancy and heat, it’s about family gatherings and pulled pork sandwiches. And, I had thought about moonlighting at a nearby diner for the summer, but I’m Not Really a Waitress.

One response so far

Aug 12 2010

FDA Pharmaceutical Approval: Glassia

Published by Paula Weigel under FDA,Pharmaceutical

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 vbudd@addisonwhitney.com

No responses yet

Next »


Alltop, all the top stories