Jazz Pharmaceuticals Receives New PDUFA Goal Date for Solriamfetol

Jazz Pharmaceuticals plc JAZZ, -0.82%today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for its new drug application (NDA) for solriamfetol as a treatment to improve wakefulness and reduce excessive daytime sleepiness in adult patients with narcolepsy or obstructive sleep apnea (OSA). The updated Prescription Drug User Fee Act (PDUFA) goal date is now March 20, 2019.

The FDA determined that an NDA submission made by Jazz during the course of discussions regarding draft labeling for solriamfetol constitutes a major amendment to the NDA, resulting in a three-month extension of the PDUFA goal date to provide time for a full review of the submission.

“We appreciate the opportunity to work with the FDA to complete the review process as soon as possible,” said Jed Black, M.D., senior vice president, Sleep and CNS Medicine at Jazz Pharmaceuticals and adjunct professor, Stanford University Medical Center, Stanford Center for Sleep Sciences and Medicine. “We are committed to addressing unmet needs in sleep medicine and look forward to offering solriamfetol as a meaningful treatment option for patients living with excessive daytime sleepiness associated with narcolepsy or OSA.”

Jazz Pharmaceuticals will host a brief investor conference call and live audio webcast on Friday, December 21, 2018 at 8:30 a.m. EST (1:30 p.m. GMT) to discuss the PDUFA goal date extension and a business update. The live webcast may be accessed from the Investors section of the company’s website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the conference call to ensure adequate time for any software downloads that may be necessary. Investors may participate in the conference call by dialing +1 855 353 7924 in the U.S., or +1 503 343 6056 outside the U.S., and entering passcode 6766127.

A replay of the conference call will be available through December 28, 2018 by dialing +1 855 859 2056 in the U.S., or +1 404 537 3406 outside the U.S., and entering passcode 6766127. An archived version of the webcast will be available for at least one week in the Investors section of the company’s website at www.jazzpharmaceuticals.com.

https://www.marketwatch.com/press-release/jazz-pharmaceuticals-receives-new-pdufa-goal-date-for-solriamfetol-for-excessive-daytime-sleepiness-associated-with-narcolepsy-or-obstructive-sleep-apnea-2018-12-21