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FDA staff: Jazz drug works, safeguards an issue
August 18, 2010 / 7:19 PM / 7 years ago

FDA staff: Jazz drug works, safeguards an issue

WASHINGTON (Reuters) - U.S. drug reviewers said a Jazz Pharmaceuticals Inc medicine helped patients with fibromyalgia, sending shares up as much as 16 percent Wednesday on hopes an approval could sharply boost the company’s sales.

Food and Drug Administration staffers said the drug, sodium oxybate or JZP-6, was effective in treating the pain disorder. But they also questioned whether proposed safeguards would 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. In afternoon trading, shares were up 6.3 percent at $10.90.

WBB Securities analyst Steve Brozak said he expects the FDA to clear JZP-6 because many fibromyalgia patients suffer debilitating pain despite treatment with current drugs.

“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.

The FDA staff said they would ask the advisory panel whether the company’s risk reduction plan was adequate to grant approval of JZP-6 for fibromyalgia, a poorly understood disorder that causes pain and fatigue. Reviewers said it was “unclear” whether the plan would “fully mitigate” improper use and dosing errors.

The reviewers also said data do 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 life-threatening comas.

Sodium oxybate would be used more widely for fibromyalgia than for nacrolepsy, raising greater abuse concerns, FDA reviewers said. About 5 million Americans have fibromyalgia, according to the National Institutes of Health.

Jazz outlined controls similar to those for Xyrem, which is distributed only from one pharmacy. FDA reviewers said documented abuse or diversion of Xyrem was “very low.”

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

Having two different brand names and risk plans for the drugs also could cause confusion, FDA staff said. Jazz has proposed the name Rekinla for the fibromyalgia use.

Jazz said its controls on Xyrem for the past eight years have minimized abuse and would work 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 summary prepared for the FDA panel.

Company studies found up to 46 percent of patients had their pain reduced by nearly one-third when taking Xyrem. That compared with between 20 percent and 27 percent who reported that level of pain relief with a placebo.

In a statement on Wednesday, Jazz said it is “committed to implementing a responsible (risk management plan) that will enhance patient safety and minimize abuse and diversion.”

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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