cannabisnews.com: Senate Bill Makes GHB A Controlled Substance Senate Bill Makes GHB A Controlled Substance Posted by FoM on November 23, 1999 at 11:23:48 PT Except for Medical Uses Source: PRNewswire Orphan Medical, Inc. (NASDAQ:ORPH) today announced that the U.S. Senate has approved legislation (S 1561) directing the Attorney General to make illicitly-manufactured gamma hydroxybutyrate (GHB) an illegal substance, while making the Company's medically-formulated GHB product, Xyrem(R) (sodium oxybate) Oral Solution, available to treat patients with narcolepsy, a debilitating disease. The Senate vote follows the approval of a similar bill in October by the U.S. House of Representatives.Sponsored by Sen. Spencer Abraham (R-Mich.), the bill directs the Attorney General to use emergency scheduling authority for placing illicitly made GHB in Schedule I, the same category as heroin and other illegal drugs. The bill also directs the Attorney General to treat medically-formulated GHB for clinical trials under an investigational new drug (IND) applications or for prescribed medical treatment as a Schedule III substance.John H. Bullion, Orphan Medical's president and chief executive officer, said, "H.R. 2130 as passed by the House and amended Friday by the Senate will enable us to continue developing a promising treatment for narcolepsy, a chronic neurologic disorder that affects an estimated 125,000 people in this country. If signed into law, this legislation will strike the correct balance between medical use of GHB and stopping its illicit manufacture."Narcolepsy is characterized primarily by unavoidable daytime sleep episodes and cataplexy, a sudden and often total loss of muscle control that can cause a person to collapse during waking hours. Cataplexy attacks occur in response to strong emotional reactions such as laughter, anger, or surprise. There are currently no satisfactory treatments for cataplexy and no drugs are approved for this condition.Based on its meeting with the FDA in September to determine submission requirements for Xyrem, the Company expects to be able to submit a New Drug Application (NDA) for Xyrem by late third quarter or early fourth quarter in 2000. The FDA indicated that Xyrem would qualify for priority review status, which, if granted, would commit the FDA to reviewing the NDA within six months of submission or by spring of 2001.Orphan Medical is dedicated to patients with inadequately treated or uncommon diseases. To that end, the Company acquires, develops, and markets products of high medical value for patients within selected strategic therapeutic market segments. Orphan Medical's Internet Web Site address is: http://www.orphan.com Information on the bill may also be found on the US Senate web site at: http://www.senate.govThe 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. All forward-looking statements are qualified by, and should be considered in conjunction with, such cautionary statements. Published: November 22, 1999http://www.prnewswire.com/Contact: John Howell BullionCEO of Orphan Medical, Inc.Phone: 612-513-6900 Home Comment Email Register Recent Comments Help Comment #1 posted by FoM on November 23, 1999 at 11:50:05 PT: Transcript's From Politically Incorrect 11/22/99 Excerpt from transcript:Well, because proposition 215 passed in '96, where the people -- somehow the will of the people, the conservative byword, the will of the people, somehow when the people are for marijuana or gay marriage or assisted suicide, suddenly the will of the people goes right out the window. Full transcript's from PI's show last night. I didn't know how to make an article out of it but I wanted to post it so you all can check it out. Transcript's From Politically Incorrect 11/22/99 [ Post Comment ] Post Comment Name: Optional Password: E-Mail: Subject: Comment: [Please refrain from using profanity in your message] Link URL: Link Title: