UPDATE 2-FDA declines approval of Jazz drug for fibromyalgia

Jazz Pharmaceuticals Inc (JAZZ.O) said the U.S. health regulator did not approve its experimental drug to treat the pain disorder fibromyalgia and suggested the need for additional clinical studies, sending its shares down 6 percent in pre-market trade.
"This news does not come as a surprise to us... I think it will be a long way for fibromyalgia, with several years of delay," Capstone Investments analyst Difei Yang said.
The U.S. Food and Drug Administration's (FDA) complete response letter said the drug, JZP-6, could not be approved in its present form and "discusses a number of topics, including the need for additional clinical studies," Jazz Pharma said in a statement.
In August, a U.S. advisory panel rejected the drug for fibromyalgia -- a poorly understood disorder that causes pain and fatigue -- amid concerns the product could be misused as a "date-rape" drug. [ID:nN20135341]
"Based on the committee members' inputs at the time of the panel meeting, I think there will be an additional clinical trial, we don't know the scope of the clinical trial but another trial means the drug will be delayed by at least two years," the analyst added.
The complete response letter sent to the company also addresses issues like the appropriate patient population, methods for ensuring safe use, the proposed risk evaluation and mitigation strategy, concentration and trade name for the product.
The analyst, who did not change her rating on the stock, said another trial could cost the company in millions and there could be a possibility the company suspends the program altogether.
"However, Jazz should not make any hasty decision and I think they will take time to decide," Difei added.
The company said it has requested a meeting with the FDA to discuss and clarify the contents of the letter.
Jazz Pharma's shares fell 27 percent in the first trading session after the panel rejected the drug on Aug. 20. They have regained most of their losses since then to close at $10.11 Friday on Nasdaq. The stock was down 6 percent at $9.46 in pre-market trade on Monday.

**Published in "Reuters"