Every pharmaceutical asset begins with a nonproprietary, generic name, or an International Nonproprietary Name (INN). This name could potentially be the first strategic decision you make for the commercial life of your brand.

But what exactly is an INN name and why do they exist?

Since the inception of the INN naming system in 1950 it has been providing health professionals with a way to uniquely and universally identify each pharmaceutical substance. INN’s are not only important in identifying a drug’s pharmaceutical ingredients but in providing safe prescription and dispensing of medicines to patients, and communication between health professionals worldwide. The World Health Organization (who manages & issues INN’s) issues INN’s in English, Latin, French, Russian, and Spanish, and more recently Arabic and Chinese versions are also being issued.

Here Vince Budd, Senior Vice President at Addison Whitney, speaks of the importance INN’s have on the success and lifecycle of a drug:

“Although INN’s aren’t actually considered intellectual property, developing an INN is without a doubt a strategic endeavor that many commercial, medical and regulatory officers take very seriously. First, the commercial team of an organization sees this as the first opportunity to put some sort of face or image to the asset. Although WHO would like manufactures to use trivial or fantasy letter strings when building generic names around INN stems, many approved INN’s are actually quite suggestive about the product. This helps some of the branding activities that soon follow. Also, many manufacturers must think about the life cycle of the asset and potential generic competition, which also impacts the type of INN name that is sought. The bottom line is INN development is serious business and the wrong or right name can certainly have an impact on the future success of a drug. “

According to WHO there are roughly 8,000 INN’s listed today, and that number grows by approximately 120-150 each year. Every INN must be submitted to and approved by WHO, and must follow their general principles for developing INN’s.

Source: World Health Organization

If you plan to purchase cigarette packs after September 2012 you may be surprised, or even disturbed by what you see. The Food and Drug Administration is requiring graphic warning labels with images ranging from a man exhaling smoke through a tracheotomy hole in his neck to a diseased lung to be placed prominently on cigarette packs. Cigarette marketers also will be required to place 1-800-QUIT-NOW numbers on new packaging.

The vivid images are the biggest change to cigarette warning labels since the mid 1980s, when the government began requiring tobacco companies to put health warnings on cigarette packs and tobacco ads. Targeting the cigarette packages themselves shows that the FDA understands the importance of compelling package design. Consumers are influenced by the entire experience of a product. The design of the outside of a package is just as important as what’s inside. A package is more than just a container; it is an asset that can motivate a purchase. Having an effective package design in a crowded marketplace is essential to making a product stand out.

So where does a tobacco company go from here? How does one market a product with packaging designed to shock consumers and discourage them from using the product? “The cigarette companies are in an environment where their product is seen as dangerous,” Brannon Cashion, president of Addison Whitney, told USA TODAY. He points out that tobacco marketers have done a good job dealing with growing anti-smoking efforts. What they need to do is stress innovation, such as developing low nicotine and electronic cigarettes.

“In order to continue to manufacture the product, they have to continue to put innovations in place that can do everything possible to make as safe an environment as possible for those who smoke and the people most affected with their smoking.”

For more information on the new FDA cigarette health warnings, click here.

FDA approves Edarbi to treat high blood pressure (source: FDA Press Announcement)

On Friday, February 25, 2011, The U.S. Food and Drug Administration approved Edarbi tablets (azilsartan medoxomil) to treat high blood pressure (hypertension) in adults.

Data from clinical studies showed Edarbi to be more effective in lowering 24-hour blood pressure compared with two other FDA-approved hypertension drugs, Diovan (valsartan) and Benicar (olmesartan).

“High blood pressure is often called the ‘silent killer’ because it usually has no symptoms until it causes damage to the body,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Drug Products in the FDA’s Center for Drug Evaluation and Research. “High blood pressure remains inadequately controlled in many people diagnosed with the condition, so having a variety of treatment options is important.”

Edarbi will be available in 80 milligram and 40 mg doses, with the recommended dose set at 80 mg once daily. The 40 mg dose will be available for patients who are treated with high-dose diuretics taken to reduce salt in the body.

Blood pressure is the force of blood pushing against the walls of the arteries as the heart pumps. If blood pressure rises and stays high over time, it can damage the body in many ways. Nearly 1 in 3 adults in the United States has high blood pressure, which increases the risks of stroke, heart failure, heart attack, kidney failure, and death.

Edarbi is an angiotensin II receptor blocker (ARB) that lowers blood pressure by blocking the action of angiotensin II, a vasopressor hormone.

Adverse reactions reported by patients taking Edarbi in clinical trials were similar to those reported by those taking an inactive drug (placebo).

Edarbi has a boxed warning that says the use of the drug should be avoided in pregnant women because use of the drug during the second or third trimester can cause injury and even death in the developing fetus. If a woman becomes pregnant while using the drug, it should be discontinued as soon as possible.

Edarbi is made by Takeda Pharmaceutical North America of Deerfield, Ill.

For more information on pharmaceutical naming, branding, research or submission documents, please contact Vince Budd at Addison Whitney via email or phone 704.697.4021.

Clinical Data, Inc. (NASDAQ: CLDA), today announced that the U.S. Food and Drug Administration (FDA) has approved vilazodone HCl tablets, to be marketed under the brand name Viibryd™, for the treatment of adults with major depressive disorder (MDD). Viibryd is a new molecular entity and the first and only selective serotonin reuptake inhibitor and 5HT1A receptor partial agonist. Clinical Data plans to make Viibryd available in U.S. pharmacies in the second quarter of this year.

“It is also the first drug that the Company has developed, and to have received marketing approval from the FDA on its first review is a significant milestone for Clinical Data.”

“When treating MDD, our goal is to offer treatment options that meet the individual needs of each patient,” said Stephen M. Stahl, M.D., Ph.D., Professor of Psychiatry, University of California, San Diego. “Viibryd is an important new treatment option with proven efficacy and a demonstrated safety profile.”

The mechanism of the antidepressant effect of Viibryd is not fully understood but is thought to be related to its enhancement of serotonergic activity in the central nervous system (CNS) through selective inhibition of serotonin reuptake. Viibryd is also a partial agonist at serotonergic 5HT1A receptors; however, the net result of this action on serotonergic transmission and its role in Viibryd’s antidepressant effect are unknown.

For more information about recent drug approvals or pharmaceutical branding, please contact Vince Budd at vbudd@addisonwhitney.com