Shares of Jazz Pharmaceuticals shot up 32 percent this morning after the developer detailed positive Phase III data for a new drug--JZP-6--that treats the pain and main symptoms linked with fibromylagia. That data sets the stage for an NDA later this year, providing some cheerful news after a long stretch of grim tidings at the Palo Alto, CA-based developer.
The 548 patients in the late-stage trial were divvied into three groups. There was a placebo arm, a group treated with 4.5 grams of sodium oxybate a night and a third group that received 6 grams of sodium oxybate a night. Fifty-four percent of the patients in the 4.5 gram arm reported a significant reduction in pain as well as improvements for fatigue and sleep patterns. Fifty-nine percent of the higher-dose patients and 35 percent of the patients in the placebo arm said they experienced similar results. And Jazz believes the data is good enough to support its new drug application to the FDA by the end of this year.
"Millions of people are diagnosed with fibromyalgia and there is a continuing unmet need for therapies that address the constellation of symptoms that can have a significant impact on patients' quality of life," said Dr. Todd Swick, one of the study's investigators and medical director of the Houston Sleep Center.
Jazz stock rallied on the news, but is still down by more than 50 percent over the past year. Investors have been rattled to see the company default on $119 million in debt last March as it burned through cash reserves.
- read the report from Dow Jones