FDA staff: Jazz drug works, risk plan an issue

Image representing Jazz Pharmaceuticals as dep...

By Lisa Richwine

WASHINGTON | Wed Aug 18, 2010 11:23am EDT

(Reuters) - U.S. drug reviewers said a Jazz Pharmaceuticals Inc medicine helped patients with the pain disorder fibromyalgia, sending shares up 14 percent Wednesday on hopes an approval could sharply boost the company's sales.

Food and Drug Administration staff said the drug, sodium oxybate or JZP-6, was effective. But they also questioned if the company's proposed safeguards would adequately prevent improper use. The medicine contains an ingredient notoriously abused as a "date rape" drug.

The company "provided sufficient evidence to support the efficacy" of the drug, FDA reviewers said in documents prepared for an advisory panel that will provide input on Friday.

Jazz shares rose as much as 16 percent on the Nasdaq early on Wednesday and were still up 11.6 percent at $11.44 in late morning.

WBB Securities analyst Steve Brozak said he expected the FDA would approve the drug because many fibromyalgia patients suffer debilitating pain that is not helped by current options.

"The FDA is telegraphing that it's effective. Now it's a question of how do we go out there and control the dispensing of the drug," Brozak said, adding "there's always a way to meet safeguards."

Brozak estimated sales of $300 million by 2015 for the fibromyalgia drug. That would be a boost to Jazz, which reported 2009 total revenue of $128 million.

FDA staff said they would ask the advisory panel if the company's risk reduction plan was adequate to grant approval of sodium oxybate for fibromyalgia, a poorly understood disorder that causes pain and fatigue. They said it was "unclear" if the company's plan "will fully mitigate" risks of improper use.

The reviewers also said data does not support a proposed claim of improved sleep.

The FDA usually follows panel recommendations when deciding whether to approve drugs. A final decision is due by October 11.

Jazz sells a similar drug under the name Xyrem for treating the sleep disorder narcolepsy. Both medicines are forms of GHB, or gamma hydroxybutyrate, a chemical known as a party drug for getting high or sedating women before raping them.

GHB, a colorless, tasteless liquid, is slipped into drinks at parties to sedate women and rape them or to get high, experts say. Some bodybuilders also use GHB to build muscles.

At high doses, GHB's sedative effects can be dangerous, putting people into a life-threatening coma.

Sodium oxybate would be used much more widely for fibromyalgia than for nacrolepsy, raising greater concerns about misuse, FDA reviewers said.

Jazz outlined controls for the fibromyalgia drug similar to ones for Xyrem, which is distributed only from one pharmacy.

The company proposed distribution from 15 pharmacies initially to meet the expected larger demand from fibromyalgia patients. FDA staff said "it is unclear to us how this modification impacts the safe use of sodium oxybate."

The reviewers also said having two different brand names and risk plans for the drugs could cause confusion. Jazz has proposed the name Rekinla for the fibromyalgia use.

Jazz said its controls on Xyrem had minimized abuse and would work effectively for Rekinla.

"Sodium oxybate can provide a solution to the unmet needs of those patients with fibromyalgia who continue to seek broad symptom relief in spite of their current therapies," the company said in a separate summary prepared for the advisory panel.

Other medicines approved for fibromyalgia are Pfizer Inc's Lyrica, Eli Lilly and Co's Cymbalta and Forest Laboratories Inc's Savella.

(Reporting by Lisa Richwine, editing by Gerald E. McCormick and Matthew Lewis)
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