Well, well, well. Sepracor, the pharmaceutical company that we love to hate for reneging on its pledge to comply with PhRMA’s Guiding Principles for DTC advertising (see, for example, “Sepracor Sneaks In Lunesta Reminder Ad” and followup at “Adventures of PhRMA Intern!“), said sales of its sleeping pill Lunesta will be lower than expected.

Lunesta is a “dog,” said David Southwell, Sepracor’s chief financial officer, in an interview.

Actually, what he said was:

“We had thought we would spend a lot on direct-to-consumer advertising in the first half and back off in second half,” he said. “Now we find we’re the lead dog in the sled and to expand the market we need to expand our marketing and promotion budget in the second half of the year.”

Sepracor blamed its lower than expected Lunesta sales on overall poor market performance in the category due to concerns over claims that certain drugs (ie, Ambien) can cause episodes of amnesia, sleep walking and binge eating.

Perhaps Sepracor’s doggie ate its marketing and sales plan!

But have no fear. When all else fails, try “indication bloat” or what some call “disease mongering.”

“Sepracor said it needs to differentiate Lunesta from other products if it is to sustain its rate of growth. The company is gathering an increasing amount of clinical data showing Lunesta to be effective in patients with co-existing conditions such as depression, anxiety, rheumatoid arthritis and menopause.” (see Reuters story.)

Readers of this blog may recall that way back in September 2005, I predicted exactly this inevitable ploy (see “Insomnia–the Next DTC Frontier“).

As the competition for market share heats up, you can expect to see these brands push the DTC advertising “envelope” the same way that erectile dysfunction (ED) drug ads did. What I am talking about is:

Indication Bloat — the tendency to inflate the estimated number of people that suffer from the drug’s indicated condition. I have written on this topic before, using ED as a case study (see “Indication Bloat – The Next DTC Issue“). Like ED, insomnia may be difficult to define and most ads I’ve seen hardly mention insomnia at all. Instead, the ads use phrases like “Trouble Sleeping?” or “Tossing & Turning?” Here’s some numbers you might hear:

An estimated 126 million adult Americans experience at least one insomnia symptom a few nights a week, according to the National Sleep Foundation, a group which receives some of its funding from drug companies. Only about a third of sufferers are actually diagnosed with insomnia, and a small fraction of those are treated with prescription medication. (“Ad war looms in crowded sleep aid market”; Boston Globe, July 19, 2005)

It sounds like we will see MORE, not less DTC ads for Lunesta in the future. These ads, however, won’t be talking about “restless minds” worrying too much about work and such, but will take on a more serious medical tone similar to what we have seen with ED (erectile dysfunction) drug ads.

New Lunesta ads will say that insomnia could be a sign or symptom of a serious medical condition like depression and RA. The ads will focus more on women, especially peri-menopausal women in their 40s.

Sepracor may opt to take the unbranded DTC route similar to the GSK/Bayer “Mens Facts” ads that market Levitra to men with high blood pressure, high cholesterol, or diabetes (see “Immutable Laws of DTC Domain Naming” and “Disease Awareness or Disease Mongering?“).

One good result of all this may be that Sepracor will finally stop running “reminder ads,” which cannot help “differentiate Lunesta from other products.”

Interestingly, this move by Sepracor toward “disease awareness,” unbranded Lunesta ads and away from reminder ads, if it happens, is motivated more by market forces (ie, competition, flagging sales) than by the desire of Sepracor to abide by PhRMA’s Guiding DTC Principles. Expect Sepracor, however, to announce that the change in the ads has more to do with the latter than with the former. I mean, that’s what they should do if they were smart.

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