Purdue puts Intermezzo DTC to bed

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Why so sad, Intermezzo lightbulb? You're OK by FDA
Why so sad, Intermezzo lightbulb? You're OK by FDA

Purdue Pharma is slashing the marketing push behind the Transcept-Purdue sleep drug Intermezzo, two years after FDA approval and six months after launching a $29 million campaign to elevate the drug's profile. Transcept Pharmaceuticals announced in an SEC filing Friday it was pulling its 90 contract reps off the promotional effort, leaving the balance to Purdue's in-house analgesic sales force. Purdue told MM&M that the Direct-to-Consumer campaign, created by Chicago firm AbelsonTaylor, stopped in March, along with the majority of its overall DTC outreach. Purdue told MM&M it has not completely walked away from the consumer space, and to expect an upcoming WebMD Intermezzo promotion. The website is staying live, as is the CRM program for patients who register with the site.

The zolpiden sleep medication is unique in the sleep category for two reasons: first, unlike Sanofi's zolpiden Ambien franchise, its indication is specifically for patients who wake up in the middle of the night and can't go back to sleep, as opposed to the competition which is meant to provide longer-term coverage.

Intermezzo's second point of departure is that its dosing is lower than the competition. This may seem like a given, considering the shorter time span the drug covers, but the lower dosing – from an off-label perspective— gave it an unexpected advantage: The Food and Drug Administration announced in January that it wanted drug makers to cut back on the allowable doses, based on findings that the patients were waking up feeling alert, but impaired because of the amount of the drugs still in patient's systems when they wake up.

FDA set the threshold at 5mg for drugs that promised immediate sleep and 6.35mg for controlled release variations. Intermezzo's 3.25mg version was below this level, and the data that encouraged the FDA to lower dosing on other brands was based on impaired driving information Intermezzo provided with its regulatory review application.

Purdue told MM&M in January, when the FDA announced the new dosing rules, that it did not anticipate a sales boost for the drug, which also has a PI that indicates consumers may be impaired when they wake up.

Beyond the zolpidem crowd, the sleep market is a pretty crowded one. Competition includes Sunovion's Lunesta (eszopiclone) and Takeda's Rozerem (ramelteon). Transcept's first quarter report also notes that off-label competition of sleep drugs drugs like Pfizer's shorter-term Sonata (zaleplon) and Pernix's Silenor (doxepin) as well as the antidepressant trazodone, answer that same short-term consumer need.

Merck is also set to get into the mix: its experimental treatment suvorexant is scheduled to go before the FDA this summer. Its hook is that it helps patients fall asleep and stay asleep. The treatment also works by focusing on a narrower part of the central nervous system, and early studies indicated that it was not associated with binge eating, a side effect that has been associated with other sleep aids.

Transcept could not be reached for comment.
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