Chesterfield pharmaceutical company secures FDA approval for narcolepsy drug
CHESTERFIELD — At long last, the Chesterfield pharmaceutical company Avadel on Monday said it has received regulatory approval for its narcolepsy drug.
A successful rollout would mean a payoff for the company’s yearslong bet on its narcolepsy drug. Avadel has made the drug its sole focus in recent years and is now expanding as it prepares to bring it to market.
The company has grown to nearly 120 employees, CEO Greg Divis said in an interview Monday, up from about 35 last year. It will continue to grow to about 130 to 135 in total.
The new drug aims to treat narcolepsy symptoms, including excessive daytime sleepiness and cataplexy — sudden, uncontrollable muscle weakness or paralysis, which can cause buckling knees and slurred speech.
“It’s not really widely understood. It’s unfortunately characterized in TV or movies a certain way. But it is really a chronic, debilitating neurological condition,” Divis said. “People say they have gone 15 years without sleeping through the night.”
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While other narcolepsy drugs require one dose before patients go to bed and another later in the night, Avadel’s formulation aims to give the same benefit with a once-nightly dose.
Avadel already has doses made, and hopes to have them available within about a month. The drug, Lumryz, will have seven years of market exclusivity, beginning Monday.
The development and approval of Lumryz has taken nearly a decade, Divis said.
The process was slowed, to some extent, by a legal dispute with rival Jazz Pharmaceuticals, which has a patent on a different narcolepsy drug. In February, a judge ruled that Jazz had to delist its patent, paving the way for Lumryz’s final approval.
The company now known as Avadel was founded in the early 1990s in Lyon, France, under the name Flamel Technologies. For years it did contract work, helping other businesses develop drugs.
In 2012 Flamel acquired a company in Chesterfield called Eclat and established a presence here. At the beginning of 2017, Flamel moved its headquarters to Dublin, Ireland, and took the name of a business it had purchased: Avadel Pharmaceuticals.
In 2018 the company launched Noctiva, a nasal spray aimed to prevent nighttime urination. But after a disappointing rollout, the company turned its focus to the investigational narcolepsy drug.
The company is still technically headquartered in Dublin, but much of its operations are based in Chesterfield.
Lumryz will be priced at $64.67 per gram. The dosage starts at 4.5 grams, and can be increased gradually to as many as 9 grams.
Avadel stock rose 12% on the news, closing at $11.73 on Monday.
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