Avadel launches quick start to narcolepsy drug’s marketing after long road to approval

Avadel Pharmaceuticals fired up its marketing engine and debuted advertising for its narcolepsy drug Lumryz just weeks after its full FDA approval in May. But it wasn’t exactly the quick turn it might seem, as the biopharma was working for months in anticipation after Lumryz’s tentative approval last July.

Richard Kim

As chief commercial officer Richard Kim explained, it likely would have taken five to six months to get the campaign launched if Avadel had gotten a fall approval as expected. Still, Avadel used its waiting time wisely to “sharpen its pencils” to prep marketing to get off the ground as quickly as possible.

Its inaugural campaign debuted last month called “Once at Bedtime, for Your Daytime” and touting Lumryz’s key differentiator as a once-nightly dose before bed. First-generation sodium oxybate treatments require users to wake up to take a second dose during the night. Lumryz and other sodium oxybate treatments, including Xyrem from competitor Jazz Pharmaceuticals and its newer low-sodium alternative Xywav, treat excessive daytime sleepiness for people with narcolepsy.

“Narcolepsy is a 24/7 condition, not just a daytime condition,” Kim said. “In fact, there’s research that shows the disease itself disrupts nocturnal sleep in about two-thirds of people with narcolepsy.”

While sodium oxybates are good therapies, he said, especially compared to the daytime stimulant approach that can cause nighttime insomnia, the need to wake up to take a second dose with the first generation of those drugs is “counterintuitive.”

Lumryz was inspired by an Avadel employee whose son had narcolepsy and who was on a twice-nightly traditional sodium oxybate treatment. The employee wanted not only to find a solution for his son, but also for the entire family whose sleep was also disrupted, Kim said.

“We have a very intuitive value proposition, but it’s also maybe one of the most essential fundamental unmet needs in the marketplace – which is not addressing the nighttime symptoms so that maybe there’s a chance for functionality during the daytime as well,” Kim said.

Avadel is focusing first on healthcare providers to raise Lumryz awareness, but also working on getting the once-nightly message to consumers and patients on social media. The drug has a black box warning, so traditional TV advertising is likely off the table; however, Avadel is also working with advocacy groups and reaching out to influencers in the narcolepsy community.

Still, Avadel and Lumryz’s road hasn’t completely smoothed out. There was also a multiyear court battle with Jazz alongside the FDA delays over the past year. Jazz had sued Avadel for patent infringement, with an appeals decision in February that required Jazz to delist a specific ‘963 patent from its Orange Book, upholding and finalizing a previous decision.

Now Jazz is suing the FDA and HHS, filing in June to try to get Lumryz off the market, alleging an “unlawful” approval that conflicts with its orphan drug protections for its drug Xywav. Jazz filed the suit in federal court in late June and is asking a judge to invalidate Lumryz’s FDA approval and award court and attorney costs.

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