FDA, New Products

As generic entry looms for its cash cow, Jazz wins FDA nod for follow-up sleep disorder drug

After a 3-month delay attributed to labelling discussions, Jazz Pharmaceuticals $JAZZ has notched an approval for its wake-promoting drug solriamfetol, now christened Sunosi.

Like Xyrem — the blockbuster narcolepsy drug that accounts for the bulk of Jazz’s sales — Sunosi is designed to treat excessive daytime sleepiness for patients with obstructive sleep apnea (OSA) as well as narcolepsy. In 2018, Xyrem sales registered at $1.4 billion, translating to over 70% of total revenue. But with Sunosi in tow, total product sales are expected to jump substantially.

Jazz bought Sunosi from Aerial Pharma in 2014 after the drug had passed muster in 2 Phase II trials for $125 million upfront. It’s the first dual-acting dopamine and norepinephrine reuptake inhibitor to be approved by the FDA, and although the company is unclear as to how it works, the drug has improved patients’ overall clinical condition compared to a placebo across four Phase III studies.

Bruce Cozadd

“With this approval, a new, daytime medicine that can provide sustained wakefulness throughout the day will be available for patients,” CEO Bruce Cozadd said in a statement. “The FDA approval of Sunosi also represents an important milestone for Jazz as we continue to offer new treatment options that address unmet needs for people living with chronic, and often debilitating, sleep disorders.”

Sunosi is approved with once-daily doses of 75 mg and 150 mg for patients with narcolepsy and doses of 37.5 mg, 75 mg, and 150 mg for patients with OSA — but notably not 300 mg, Umer Raffat of Evercore ISI wrote in a note.

[In] our opinion, not getting 300 mg approved might be the single most important thing that makes this label as clean as it is. As you scroll to page 8 of (the) label, there is a table on BP and HR data on doses including 300 mg dose — and you can clearly see why FDA did NOT approve that dose despite better efficacy. In fact, label mentions “dosages above 150 mg do not confer increased effectiveness sufficient to outweigh AE”.

By not having 300 mg, the BP and HR events merely became a warning, and NOT a blackbox. And…although label recommends assessing BP and HR before initiating and during treatment, (the) reality is that many narcolepsy and OSA patients have multiple CV risk factors

Jazz is waiting for a DEA scheduling before it can launch the drug, a process that’s estimated to take 90 days. Meanwhile, the company will be hiring 50 more sales reps for their 95-member sleep team, according to Cowen analysts.

By making some cross-trial comparisons between Sunosi and current standard of care Provigil/Nuvigil (which recently went generic), they gave the Jazz drug a ringing endorsement as a best-in-class agent.

“Importantly, our consultant checks and survey results indicate that Sunosi appears to be a needed treatment option and a likely $500 million+ long duration product,” they wrote. “The bottom line is that solriamfetol appears to be the most effective wake-promoting agent ever developed for EDS.”

The best place to read Endpoints News? In your inbox.

Comprehensive daily news report for those who discover, develop, and market drugs. Join 47,900+ biopharma pros who read Endpoints News by email every day.

Free Subscription

Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

Visit Endpoints Careers ->