FDA Decision Analysis: Orphan Medical
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The FDA
Advisory committee for Peripheral and Central Nervous System Drugs
voted yesterday to approve Orphan Medical’s
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a common symptom of the disease narcolepsy. This symptom, called cataplexy,
occurs in a majority of narcoleptic patients and can be quite debilitating by
causing patients to unexpectedly experience paralysis and collapse. Narcolepsy
affects close to 140,000 Americans.
The committee voted 6 to 3 to verify its efficacy toward treating this symptom
and thought the data Orphan Medical presented was convincing. However, the
committee was very concerned with the safety of the drug and its potential
distribution, if approved. There were also concerns about its side effects as
well. Unfortunately, the main component of Xyrem is gamma hydroxybutyrate
or GHB, infamously known as the “date rape” drug. The committee had
grave concerns about the potential availability of this drug, if approved, as
well as many of the public participants at the meeting. Ultimately, the full FDA
will look at the drug in July and decide on its fate.
Cephalon
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narcolepsy on the market today and would be the competition for Orphan Medical.
Cephalon’s drug, Provigil, has been growing in sales and the company is looking
toward the FDA to broaden its use to treat other disorders associated with
chronic fatigue. Orphan Medical’s Xyrem may have a difficult time taking
away market share from an established drug, if approved by the full FDA. In
addition, doctors may be reluctant to prescribe a drug that the public perceives
being linked to date rape.