UPDATE 3-US FDA staff–Jazz drug works, safeguards an issue

* Jazz shares rise as much as 16 pct

* FDA staff: Sodium oxybate effective for fibromyalgia

* Agency wants panel to weigh risk reduction plan

* Advisory panel to consider drug on Friday
(Adds company comment, updates shares)

By Lisa Richwine

WASHINGTON, Aug 18 (BestGrowthStock) – U.S. drug reviewers said a
Jazz Pharmaceuticals Inc (JAZZ.O: ) 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 Oct. 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
(PFE.N: ) Lyrica, Eli Lilly and Co’s (LLY.N: ) Cymbalta and Forest
Laboratories Inc’s (FRX.N: ) Savella.
(Reporting by Lisa Richwine, editing by Gerald E. McCormick
and Matthew Lewis)

UPDATE 3-US FDA staff–Jazz drug works, safeguards an issue