Naming a first drug for a small biotechnology company evokes images of first-time parents exhausting all channels , from books, the Internet, family, friends, and even paid professionals, to name their precious child.
Except, in the case of drug naming, the U.S. Food and Drug Administration has the final say, not the company.
For Somaxon Pharmaceuticals, the FDA verdict is still out on Silenor, the name the small San Diego-based biotechnology company selected for its insomnia drug after three months of deliberation, said Doranne Frano, senior director of regulatory affairs at Somaxon.
Yet Frano is optimistic that the drug name will satisfy the FDA’s stringent requirements, once Somaxon submits the name as part of a huge regulatory package to try to win marketing approval.
According to the company’s research, Silenor doesn’t sound, nor is it spelled like any other marketed or unapproved drug.
The name also does not seem to refer to a medical procedure or a laboratory test.
Finally, it doesn’t promote or make misleading claims, Frano said.
To ensure that all of these criteria were met, Somaxon consulted three outside experts, including the Nuancing Group, a San Diego-based marketing company that specializes in brand naming, which worked closely with Somaxon on creating and evaluating name candidates.
“We had everybody in our company (12 employees) submit five to 10 names,” said Jeffrey Raser, Somaxon’s senior vice president of marketing.
“The Nuancing Group came up with 50 more and collectively we ranked them down to about five.”
Somaxon hired another marketing research firm, the Opinion Leader Group of Paramus, N.J., to test the five names for likability and stickiness with psychiatrists, primary care doctors and consumers, Raser said.
The real test came with the patent attorneys at the law offices of Knobbe, Martens, Olson & Bear LLP in San Diego.
“The Nuancing Group was instrumental in assisting us with the final name, but the (attorneys) looked 10 times deeper at potential conflicts,” Raser noted.
Silenor came out the winner, in part because doctors attributed the name to “peaceful sleep” and “silence,” which are great characteristics for a drug aiming to help patients sleep, he said.
Elizabeth Goodgold, owner of the Nuancing Group, agreed.
“The essence of naming a great product is to attribute a name that’s easy to say, easy to spell, and reflects the personality and the target,” Goodgold said.
A Somaxon employee created the Silenor name, Raser said.
Goodgold, whose client list spans across various industries, said balancing FDA guidelines with the ideas of pharmaceutical clients can be tricky when naming drugs.
“Drugs work differently in each individual, you can’t make any promises,” Goodgold said. “We couldn’t say Somaxon’s drug is called ‘Sleep Now.’ That would be a promised benefit.”
What’s even more important in naming a new drug is to check for existing drugs with similar names, she said.
Five years ago, the FDA became involved in product naming because of the fatal confusion that results from doctors writing the wrong prescriptions, Goodgold said.
That became a consideration with Somaxon’s drug as well.
“We liked the name Triessa, but there is another drug on the market called TriNessa , which is not a sleep drug, but you have to be fearful of commonly confused words overlaid with bad physician handwriting,” Goodgold said.
In a recent updated report on drug naming activities, FDA drug safety officer Mary Gross wrote that from the drug company’s perspective, there is “no solid evidence that name confusion is causing medical errors.”
Practitioners disagree, she reported.
From their view, drug name confusion shows clear potential for error: Out of 32,000 prescriber errors, 20 percent show a link to nomenclature, she wrote in June.
Dr. Steve Green, who practices in Mira Mesa and is the chairman for the Family Practice Department of Sharp Rees-Steely Medical Group in San Diego, said he once wrote a letter to the FDA expressing his concern over two similarly named drugs.
Kos Pharmaceuticals Inc.’s cholesterol-lowering drug Advicor was already on the market when the FDA approved Andrx Pharmaceuticals Inc.’s Altocor, for the same condition, Green said.
Avoiding Problems
Not only did the two drugs sound alike, which is asking for trouble, Advicor has two active ingredients, Niacin and Lovastatin, while Altocor’s active ingredient is Lovastatin.
“I told them (the FDA) that this was creating a situation for people to make errors,” Green said. “Mistakes are hard enough to avoid during a busy day. You don’t need to have two different drugs with similar names to confuse you more.”
Green said he was pleasantly surprised to learn that the FDA recognized the potential risks, asking Andrx to change its drug’s name.
Altocor is now being sold as Altoprev.
The marketing faux pas could have landed Andrx on Goodgold’s “Duh! Marketing” list, an attention-grabber for the worst marketing errors of big companies that should know better, she said.
“The companies have every vested interest in the world that their name is distinct and that the (prescription) name is filled correctly,” Goodgold said.
Goodgold, known as a master in creating names, said it’s no coincidence that drug names can’t be found in the dictionary.
“Neology is the most powerful form of naming and are afforded the highest form of trademark protection,” she explained.
Yet, even pharmaceutical companies are slaves to fashionable trends.
“One of the big trends that started in 1999 was this obscene obsession with the last three letters of the alphabet , X, Y and Z,” Goodgold said. Proof in point, she rattled off a list: Zoloft, Zyrtec, Xenical, Xicam
“The initial use of X and Z was fascinating,” she said. But by 2003, the trend wore off.
Green said this trend wasn’t lost on doctors, but not exactly welcomed.
“The use of lots of X’s and Z’s may sound futuristic, but the problem is these aren’t letters that we use all the time, so it’s harder to differentiate them,” he found.
He prefers the pleasant “S” sound in Silenor.
“It sounds like something that may make people silent. It’s probably a good name in the scheme of things , you can remember it, and I don’t think you could mix that up with another drug.”
