Medical news on fibromyalgia syndrome from the pharmaceutical industry
Business Editors/Health/Medical Writers
Thomas Weisel Healthcare Conference
Minneapolis, MN - Orphan Medical (Nasdaq:ORPH)
announced at the Thomas Weisel Healthcare Conference that it recently held a
scientific advisory meeting with prominent clinical specialists in
fibromyalgia syndrome (FMS). The meeting identified measurement endpoints
for a proof-of-principle trial to assess Xyrem(R) (sodium oxybate) oral
solution as a treatment for the symptoms of fibromyalgia. Orphan Medical
expects to submit an Investigational New Drug (IND) application and protocol
for this trial to the U.S. Food and Drug Administration (FDA) later this
"Our advisory meeting participants strongly supported evaluating Xyrem
in the treatment of fibromyalgia based on early published data, current
clinical experience, and its known pharmacology," said William Houghton,
M.D., Chief Scientific and Medical Officer for Orphan Medical. "Sleep
disturbance and daytime fatigue are important components of fibromyalgia.
The known impact of Xyrem on sleep architecture provides a rationale for
this potential use. We are seeking to address an unmet medical need as there
are currently no approved medications for the treatment of fibromyalgia
which may affect up to two percent of the population."
Fibromyalgia Syndrome is characterized by widespread muscle pain and
stiffness. Its incidence in women is three times that of men. Other symptoms
include persistent fatigue, headaches, cognitive or memory impairment,
morning stiffness and non-restorative sleep.
"Clinical acceptance of Xyrem as a treatment for cataplexy in narcolepsy
is growing and the next step in our Xyrem life cycle management program is
the evaluation of Xyrem in treating excessive daytime sleepiness associated
with narcolepsy," said John Bullion, Chief Executive Officer of Orphan
Medical. "The treatment of fibromyalgia is the first potential indication
outside of narcolepsy. We are very encouraged by the positive support from
the advisory meeting."
The Company also indicated that the protocol for a Phase IV study
required by the FDA to assess the effects of Xyrem in sleep-disordered
breathing has been submitted and approved. Two sites specializing in
sleep-disordered breathing have been identified and are awaiting
Institutional Review Board approval. The Company will begin patient
enrollment following these approvals.
Xyrem is the first and only approved medication for the treatment of
cataplexy, a debilitating symptom of narcolepsy and was commercially
launched in October of 2002. Cataplexy, a sudden loss of muscle tone, is
usually triggered by strong emotions such as laughter, anger, or surprise.
In its most severe form, cataplexy can cause a person to collapse. Sixty to
ninety percent of the 140,000 Americans with narcolepsy suffer from
The information in this press release may contain forward-looking
statements within the meaning of the Private Securities Litigation Reform
Act of 1995. A number of factors could cause actual results to differ
materially from the Company's assumptions and expectations. These are set
forth in the cautionary statements included in Orphan Medical's most recent
Form 10-Q or Form 10-K filed with the Securities and Exchange Commission.
CONTACT: Orphan Medical, Minneapolis
INDUSTRY KEYWORD: MEDICAL PHARMACEUTICAL TRADESHOW
SOURCE: Orphan Medical