Drug maker Jazz Pharmaceuticals Inc. (NASDAQ: JAZZ) said it failed to get an FDA nod for its JZP-6 (sodium oxybate), a potential treatment for fibromyalgia. The U.S. health regulator, in its complete response letter, informed the Palo Alto, Calif.-based company that additional clinical studies of JZP-6 would be required and that the agency wanted more information on the appropriate fibromyalgia patient population, methods to ensure the drug’s safe use, dosage and a risk management plan.
Monday’s news did not come as a great surprise given that a joint advisory committee in August voted against the approval of JZP-6 amid risks of drug abuse and accidental overdose. JZP-6 is a close relative of gamma-hydroxybutyric acid (GHB), which has been used as a club drug.
Since 2002, Jazz has been selling JZP-6 as a treatment for sleep disorders under the brand name Xyrem. It also markets Luvox CR (fluvoxamine maleate) for the treatment of both obsessive-compulsive disorder and social anxiety disorder.
Jazz is focused on the development and commercialization of pharmaceutical products to meet unmet medical needs in neurology and psychiatry. Expanding its market to include fibromyalgia would be a significant growth opportunity for the drug maker. Fibromyalgia, one of the most common chronic pain conditions, affects an estimated 10 million people in the United States and an estimated 3-6% of the world population, according to the National Fibromyalgia Association.
Following Monday’s negative FDA decision, the company said it has requested a meeting with the FDA in order to discuss and clarify the contents of the complete response letter and will then evaluate its next steps for JZP-6.
“We continue to believe there is a significant unmet medical need among fibromyalgia patients that could be met by JZP-6 if it were approved by FDA,” Bruce Cozadd, chairman and CEO of Jazz stated in a press release.
So far JAZZ has reached a 52-week low and high of $6.01 and $13.95, respectively. It has a consensus recommendation of Outperform.
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