U.S. Markets open in 8 hrs 1 min

Jazz Pharmaceuticals' Sleep Drug NDA Awaits FDA Decision

Zacks Equity Research

Jazz Pharmaceuticals plc’s JAZZ NDA for lead pipeline candidate solriamfetol (JZP-110) awaits FDA decision on Wednesday. The new drug application (“NDA”) under review seeks approval of the drug as a treatment to improve wakefulness and reduce excessive daytime sleepiness (“EDS”) in adult patients with narcolepsy or obstructive sleep apnea (“OSA”).

The NDA was filed in March 2018 with a PDUFA date of Dec 20, 2018. However, in December, the FDA extended the review period for the NDA by three months. The extension was due to submission of updated data on draft labeling by Jazz, which was considered as a major amendment to the NDA by the regulatory authority.

Solriamfetol has also been evaluated in a phase II study for excessive sleepiness associated with Parkinson's disease. Top-line data is expected soon.

Jazz’s shares are up 9.3% so far this year compared with the industry’s rally of 17%. A potential approval to solriamfetol may lead to significant increase in the company’s share price.


We note that the company has developed solriamfetol in an indication similar to its sole marketed drug, Xyrem. The drug is currently sold across 21 countries by UCB Pharma, a multinational biopharmaceutical company with rights to market Xyrem in 54 countries. Jazz is also developing another candidate, JZP-258 (a low sodium formulation and a Xyrem follow-on product) in late-stage studies for EDS and cataplexy in narcolepsy patients.

Xyrem sales grew significantly in 2018 and totaled $1.4 billion. In 2018, the drug generated almost 75% of Jazz’s total revenues. The company expects Xyrem’s sales to be in the range of $1.53-$1.57 billion in 2019. However, several patents protecting the drug are nearing expiration, starting December 2019. Moreover, an authorized generic version of the drug is likely to hit the markets as early as 2023.

Potential approval for solriamfetol will be crucial for the company as it will strengthen Jazz’s sleep disorder portfolio as well as help offset a potential decline in Xyrem sales following a generic launch. Successful development of JZP-258 and its potential approval will be an additional boost for the company.

Some other pharma/biotech companies are developing treatments for narcolepsy. Avadel Pharmaceuticals plc AVDL is one of them. Approved drugs for narcolepsy include Teva Pharma’s TEVA Provigil and Novartis’ NVS Ritalin-SR.

A negative decision from the FDA tomorrow is likely to have a significant unfavorable impact on the company’s stock.

Jazz Pharmaceuticals PLC Price


Jazz Pharmaceuticals PLC Price | Jazz Pharmaceuticals PLC Quote

Zacks Rank

Jazz currently has Zacks Rank #3 (Hold).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

This Could Be the Fastest Way to Grow Wealth in 2019

Research indicates one sector is poised to deliver a crop of the best-performing stocks you'll find anywhere in the market. Breaking news in this space frequently creates quick double- and triple-digit profit opportunities.

These companies are changing the world – and owning their stocks could transform your portfolio in 2019 and beyond. Recent trades from this sector have generated +98%, +119% and +164% gains in as little as 1 month.

Click here to see these breakthrough stocks now >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Novartis AG (NVS) : Free Stock Analysis Report
Avadel Pharmaceuticals PLC. (AVDL) : Free Stock Analysis Report
Jazz Pharmaceuticals PLC (JAZZ) : Free Stock Analysis Report
Teva Pharmaceutical Industries Ltd. (TEVA) : Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research