Look at the duplicity of the american FDA. They have labelled Gamma-OH
a "dangerous" drug and,now,look what they do...
This is typical of US commercial maneuvers to attack foreign
products:demonisation,until they can catch up.
Source: Press Release from Orphan Medical, Inc.
PR Contact: John Howell Bullion, Orphan Medical, Inc. , (612) 513-6900
Orphan Medical Announces FDA Approval to Initiate
A Treatment IND Program
for Xyrem (Sodium Oxybate) Oral Solution
MINNEAPOLIS, Minnesota December 17, 1998 Orphan Medical, Inc.
ORPH) announced today the approval by the Food and Drug Administration
(FDA) of a Treatment IND (Investigational New Drug) for Xyrem (sodium
oxybate.Gamma-OH,in French) oral solution. Xyrem is intended to treat
the reduction of cataplexy. Narcolepsy is a chronic neurologic
characterized primarily by unavoidable daytime sleep episodes and
cataplexy. Cataplexy, a sudden and often total loss of muscle control,
affects the majority of narcolepsy patients. Narcolepsy is estimated
affect at least 125,000 patients in the United States.
During the Treatment IND, expected to begin in the first quarter of
the Company will collect additional clinical data necessary for the
submission of a new drug application (NDA) to the FDA. The FDA permits
investigational drug to be used under a Treatment IND ---->if there is
sufficient evidence of safety and effectiveness and the drug is
treat a serious disease.<---- no comment.
``This is a very important milestone for Orphan Medical,'' said John
Bullion, CEO of Orphan Medical. ``The initiation of a Treatment IND
enable the company to seek reimbursement for certain development costs
while we gather additional clinical data.''
Orphan Medical, Inc. is dedicated to patients with inadequately
uncommon diseases. To this end, the Company acquires, develops, and
products of high medical value that address these diseases within
strategic therapeutic market segments.
Orphan Medical's Internet Web Site address is http://www.orphan.com