Orphan Medical Announces New Date for FDA Advisory Committee Meeting for Xyrem(R) (Sodium Oxybate) Oral Solution NDA

Apr 11, 2001, 01:00 ET from Orphan Medical, Inc.

    MINNEAPOLIS, April 11 /PRNewswire Interactive News Release/ -- Orphan
 Medical, Inc. today announced that the Food and Drug Administration (FDA) has
 rescheduled an advisory committee review of Xyrem(R) (sodium oxybate) oral
 solution on June 6, 2001.  The Peripheral and Central Nervous System Drugs
 Advisory Committee will provide advice and recommendations to the FDA
 regarding the safety, efficacy and risk management of Xyrem.
     An Advisory Committee meeting had been previously scheduled at which Xyrem
 was to be reviewed.  The FDA requested more time so that Orphan Medical could
 respond to the agency's request for clarification of supplemental data outside
 of Orphan Medical sponsored trials.  The Company responded with additional
 information, and the FDA extended by ninety days the date by when it would
 take action on the New Drug Application (NDA).
     As defined by the FDA, Advisory Committees are established to help the
 agency make sound decisions based on good science in its review of regulated
 products.  Advisory committees consist of individuals who are recognized as
 experts in their field from many different sectors including medical
 professionals, scientists and researchers, industry leaders, and consumer
 representatives and patient representatives.
     "The FDA has been actively reviewing the information we provided.  In
 addition to supporting the FDA in its review of the NDA and preparing for the
 June meeting," said John Bullion, Chairman and CEO of Orphan Medical.  "We've
 also been very busy responding to the many patients who have expressed their
 desire in having Xyrem available for the treatment of cataplexy, a
 debilitating symptom of narcolepsy for which there currently are no approved
 medicines."
     The Company submitted a NDA requesting approval of Xyrem as a treatment
 for narcolepsy, particularly cataplexy and to improve the symptoms of
 excessive daytime sleepiness, on October 2, 2000.  The NDA received priority
 review status from FDA with a six-month review goal.  A ninety-day extension
 was granted on March 30, which moves the action deadline to early July.
     Narcolepsy is a chronic neurological disorder affecting an estimated
 100,000 to 125,000 Americans, whose main symptoms are excessive daytime
 sleepiness and cataplexy. Cataplexy is a debilitating symptom characterized by
 loss of muscle control in response to strong emotional reactions such as
 laughter, anger, or surprise. In its most severe form, cataplexy can cause a
 person to collapse during waking hours.
 
     Orphan Medical acquires, develops, and markets pharmaceuticals of high
 medical value for inadequately treated and uncommon diseases. The Company
 serves three strategic therapeutic market segments characterized by
 well-defined patient populations and served by physician specialists: Oncology
 Support, Antidotes and Sleep Disorders. The Company also markets two small
 products for specific congenital diseases.  Orphan Medical's Internet Web site
 address is http://www.orphan.com.
 
     Contact: John Howell Bullion (CEO) or Tim McGrath (CFO) of Orphan Medical
 at 952-513-6900 or Noonan/Russo Communications, Inc. (212) 696-4455
 Steven Gendel (media), ext. 212 or David Walsey  (investors), ext. 230
 news@noonanrusso.com
 
     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 Exhibit 99 to Orphan Medical's most recent
 Form 10-Q or Form 10-K filed with the Securities and Exchange Commission.
 (These documents can be accessed through the Orphan Medical Web site at
 http://www.orphan.com).  All forward-looking statements are qualified by, and
 should be considered in conjunction with, such cautionary statements.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X75534194
 
 

SOURCE Orphan Medical, Inc.
    MINNEAPOLIS, April 11 /PRNewswire Interactive News Release/ -- Orphan
 Medical, Inc. today announced that the Food and Drug Administration (FDA) has
 rescheduled an advisory committee review of Xyrem(R) (sodium oxybate) oral
 solution on June 6, 2001.  The Peripheral and Central Nervous System Drugs
 Advisory Committee will provide advice and recommendations to the FDA
 regarding the safety, efficacy and risk management of Xyrem.
     An Advisory Committee meeting had been previously scheduled at which Xyrem
 was to be reviewed.  The FDA requested more time so that Orphan Medical could
 respond to the agency's request for clarification of supplemental data outside
 of Orphan Medical sponsored trials.  The Company responded with additional
 information, and the FDA extended by ninety days the date by when it would
 take action on the New Drug Application (NDA).
     As defined by the FDA, Advisory Committees are established to help the
 agency make sound decisions based on good science in its review of regulated
 products.  Advisory committees consist of individuals who are recognized as
 experts in their field from many different sectors including medical
 professionals, scientists and researchers, industry leaders, and consumer
 representatives and patient representatives.
     "The FDA has been actively reviewing the information we provided.  In
 addition to supporting the FDA in its review of the NDA and preparing for the
 June meeting," said John Bullion, Chairman and CEO of Orphan Medical.  "We've
 also been very busy responding to the many patients who have expressed their
 desire in having Xyrem available for the treatment of cataplexy, a
 debilitating symptom of narcolepsy for which there currently are no approved
 medicines."
     The Company submitted a NDA requesting approval of Xyrem as a treatment
 for narcolepsy, particularly cataplexy and to improve the symptoms of
 excessive daytime sleepiness, on October 2, 2000.  The NDA received priority
 review status from FDA with a six-month review goal.  A ninety-day extension
 was granted on March 30, which moves the action deadline to early July.
     Narcolepsy is a chronic neurological disorder affecting an estimated
 100,000 to 125,000 Americans, whose main symptoms are excessive daytime
 sleepiness and cataplexy. Cataplexy is a debilitating symptom characterized by
 loss of muscle control in response to strong emotional reactions such as
 laughter, anger, or surprise. In its most severe form, cataplexy can cause a
 person to collapse during waking hours.
 
     Orphan Medical acquires, develops, and markets pharmaceuticals of high
 medical value for inadequately treated and uncommon diseases. The Company
 serves three strategic therapeutic market segments characterized by
 well-defined patient populations and served by physician specialists: Oncology
 Support, Antidotes and Sleep Disorders. The Company also markets two small
 products for specific congenital diseases.  Orphan Medical's Internet Web site
 address is http://www.orphan.com.
 
     Contact: John Howell Bullion (CEO) or Tim McGrath (CFO) of Orphan Medical
 at 952-513-6900 or Noonan/Russo Communications, Inc. (212) 696-4455
 Steven Gendel (media), ext. 212 or David Walsey  (investors), ext. 230
 news@noonanrusso.com
 
     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 Exhibit 99 to Orphan Medical's most recent
 Form 10-Q or Form 10-K filed with the Securities and Exchange Commission.
 (These documents can be accessed through the Orphan Medical Web site at
 http://www.orphan.com).  All forward-looking statements are qualified by, and
 should be considered in conjunction with, such cautionary statements.
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X75534194
 
 SOURCE  Orphan Medical, Inc.