Jazz scores FDA nod for sleepiness drug Sunosi, but a launch will have to wait

Stamp with blue ink that says "FDA Approved"
Jazz scored FDA approval for its next launch in Sunosi, a med to improve wakefulness in patients with narcolepsy or obstructive sleep apnea. (Olivier Le Moal/Getty Images)

It didn’t always look certain, but on Wednesday, Jazz Pharmaceuticals scored an FDA approval for sleepiness drug Sunosi. But the new drug can't roll onto the market until it clears a separate regulatory hurdle at the DEA.

The FDA approved Jazz’s Sunosi, formerly known as solriamfetol, to help narcolepsy and obstructive sleep apnea patients stay awake during the day. Next up: DEA scheduling, which typically takes 90 days or less, but has dragged out for a year or more in some cases over the last several years. Sunosi is the first approval for a new sleepiness drug in a decade, Jazz CEO Bruce Cozadd told FiercePharma.

Jazz has been involved in marketing in narcolepsy for years, but Cozadd said it’s “exciting” for the company to bring a treatment option to patients with OSA. It’s condition where sleepiness isn’t understood as well as narcolepsy, he said, but affects “all spheres” of a patient’s life. 

Sales estimates for Sunosi this year are modest, but analysts see the drug eventually pulling in hundreds of millions of dollars annually. Leerink analyst Ami Fadia, for one, figures Sunosi can generate more than $500 million by 2023, given that it works differently from other sleepiness drugs and has strong efficacy data to back it up.

As Fadia sees it, Jazz was smart to seek approval for 150 mg as the highest dose after safety data raised questions about larger amounts. The 150 mg option "offers the optimal trade off between efficacy and safety,” she pointed out. Sunosi's own label acknowledges that doses above 150 mg “do not confer increased effectiveness sufficient to outweigh dose-related adverse reactions."

RELATED: Jazz hiring 100-plus sales representatives to prep for new narcolepsy and AML launches 

The drug is approved as 75 mg and 150 mg doses for patients with narcolepsy. Sleep apnea patients have those doses plus a 37.5 mg option. 

The FDA previously delayed its decision for the drug by three months after Jazz modified its application. That decision triggered some concern about Sunosi's fate, RBC Capital Markets analyst Randal Stanicky wrote in a note to clients. 

Stanicky's team predicted 2024 Sunosi sales of $314 million, but that estimate excludes potential approvals in other diseases, such as Parkinson’s disease. The analyst said he expects an update in the coming months about Jazz's development plans now that Sunosi is approved.

Behind Sunosi, phase 3 data for idiopathic hypersomnia drug JZP-258, expected this spring, is Jazz’s “next major catalyst," Stanicky wrote.

RELATED: Jazz’s Vyxeos rollout hit a wall in Q3. What’s the holdup? 

Last year, Jazz, said it was hiring dozens of sales representatives to support the Sunosi rollout. And it started a prelaunch disease awareness campaign, Chief Operating Officer Dan Swisher told FiercePharma. The company plans to advertise to consumers as well, he said.

Jazz plans to make job offers to new sales staffers now that it has an FDA approval for Sunosi, Cozadd said. New employees will receive training and be able to pitch narcolepsy med Xyrem immediately, plus Sunosi once it clears DEA scheduling. Cozadd said the company plans to expand its sales efforts to pulmonologists, who interact with OSA patients. 

The launch will have to wait, of course, until the DEA's scheduling decision. Though that process usually takes three months or less, it can drag out for longer—much longer, in a few cases.

GW Pharmaceuticals nabbed its DEA scheduling decision for CBD-derived Epidiolex within 90 days last year, but Arena Pharmaceuticals waited more than a year for its Belviq scheduling. Eisai's Fycompa cooled its heels at the DEA for so long, the Japanese drugmaker ended up suing.

Sunosi will be Jazz's second new drug launch in as many years, following on the heels of leukemia drug Vyxeos. After rolling out that drug in August 2017, the company ran into some barriers last year as hospitals implemented restrictions on its use.

The company is pushing to grow sales for the drugs as its big moneymaker Xyrem nears the patent cliff. Jazz has inked deals to allow generic launches in 2023.

Editor's note: This story was updated with comments from Jazz CEO Bruce Cozadd.