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Latest Gamma-Hydroxybutyric acid Stories

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2010-08-22 10:55:00

A Food and Drug Administration (FDA) advisory panel on Friday significantly rejected the application of Jazz Pharmaceuticals for the approval of Xyrem (sodium oxybate) for the treatment of fibromyalgia.The drug is chemically similar to GHB -- the "date-rape" drug. Approving the drug for such a large patient population would risk flooding the streets with a pharmaceutical-grade version of the highly controlled substance."Sodium oxybate and GHB are the same thing," said Lewis Nelson, MD, of the...

2010-06-24 15:30:00

PALO ALTO, Calif., June 24 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced today that the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee will review JZP-6 (sodium oxybate) for the treatment of fibromyalgia at a joint meeting on August 20, 2010. In February 2010, the FDA accepted for filing and review the New Drug Application (NDA) of JZP-6 (sodium oxybate) for the treatment of...

2010-03-24 07:00:00

SAN DIEGO, March 24, 2010 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today the initiation of patient screening in a Phase 1 clinical trial of APD916, a novel oral drug candidate discovered by Arena that targets the histamine H3 receptor for the treatment of narcolepsy and cataplexy. "There is a need for better tolerated, more effective therapies for narcolepsy, especially narcolepsy with cataplexy," said William R. Shanahan, M.D., Arena's Vice President...

2010-02-18 16:00:00

PALO ALTO, Calif., Feb. 18 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for JZP-6 (sodium oxybate) for the treatment of fibromyalgia. Based on a standard 10-month review, the target date for the FDA to complete its review of the NDA under the Prescription Drug User Fee Act (PDUFA) is October 11, 2010. The submission is based on a comprehensive...

2010-01-18 08:00:00

WALTHAM, Mass., Jan. 18 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, despite potential safety concerns, Jazz Pharmaceuticals/UCB's sodium oxybate (JZP-6) will account for more than 15 percent of the fibromyalgia drug market in 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan. Sodium oxybate has demonstrated robust efficacy in Phase III clinical trials...

2009-12-15 06:00:00

PALO ALTO, Calif., Dec. 15 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for JZP-6 (sodium oxybate oral solution) for the treatment of fibromyalgia. The submission is based on a comprehensive clinical development program for JZP-6, including results from two Phase III clinical trials. In both trials, sodium oxybate significantly decreased pain and fatigue as well as...

2009-11-20 13:58:05

Findings could lead to new antidotes, treatments It's a naturally occurring brain chemical with an unwieldy name: 4-hydroxybutyrate (4-HB). Taken by mouth, it can be abused or used as a date-rape drug. Now, a team of Ohio and Michigan scientists have determined new routes by which 4-HB is metabolized by the body. "This is new and important information," said K. Michael Gibson, professor and chair of biological sciences at Michigan Technological University and a member of the research team....

2009-10-14 19:51:00

PALO ALTO, Calif., Oct. 14 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced today that data from the company's first Phase III clinical trial of sodium oxybate (JZP-6) for the treatment of fibromyalgia will be presented next week during the American College of Rheumatology 2009 Annual Meeting (ACR) in Philadelphia, Pennsylvania and also in November during the US Psychiatric and Mental Health Congress (US Psych Congress) in Las Vegas, Nevada. At ACR on...

2009-08-11 15:05:00

PALO ALTO, Calif., Aug. 11 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced financial results for the second quarter ended June 30, 2009. Total revenues for the second quarter were $37.3 million, compared to $15.5 million for the quarter ended June 30, 2008. Revenues for the second quarter included a $10.0 million milestone payment from UCB Pharma Limited that was received in July 2008 and recognized as revenue when the last patient completed the second...

2009-06-24 15:30:00

Preliminary top-line results of second Phase III study show highly significant decreases in pain and fatigue and improved daily function in fibromyalgia patients and confirm results from the first Phase III study PALO ALTO, Calif., and BRUSSELS, June 24 /PRNewswire-FirstCall/ -- press release, regulated information -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) and UCB (Euronext Brussels: UCB) announced today positive preliminary top-line results from the second of two Phase III clinical...


Word of the Day
glogg
  • Scandinavian punch made of claret and aquavit with spices and raisins and orange peel and sugar.
This word comes from the Swedish 'glogg,' which is an alteration of 'glodgat,' mulled (wine).
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