Navigation Links
Jazz Pharmaceuticals, Inc. Announces Receipt of FDA Orphan Drug Designation for Recurrent Acute Repetitive Seizures Product Candidate
Date:1/7/2008

PALO ALTO, Calif., Jan. 7 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) announced today that it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for its JZP-8 product candidate for the treatment of recurrent acute repetitive seizures. In December 2007, Jazz Pharmaceuticals dosed the first patient in a Phase II clinical trial of JZP-8.

JZP-8 is a novel drug delivery formulation incorporating clonazepam, a widely prescribed benzodiazepine. The product candidate is designed to be a fast-acting intranasal spray for the treatment of recurrent acute repetitive seizures in patients with epilepsy. Jazz Pharmaceuticals previously completed development activities to select the active pharmaceutical ingredient for the product, to determine its formulation, and to assess its safety and tolerability in early stage studies.

"JZP-8 is one of the first development product candidates from our internal product identification and development program to enter Phase II," said Samuel R. Saks, M.D., Chief Executive Officer of Jazz Pharmaceuticals. "Dosing of the first patient in our Phase II clinical trial and receipt of orphan drug designation are important milestones for this program."

About Recurrent Acute Repetitive Seizures

Recurrent acute recurrent repetitive seizures (ARS) are bouts of acute seizure activity occurring within a 24-hour period in adults and a 12-hour period in children. ARS, also called seizure clusters, occurs in a small subset of patients with epilepsy who regularly experience breakthrough seizures in flurries or clusters despite treatment with a regimen of anti-epileptic drugs. ARS is a rare disorder, with an estimated prevalence in the United States of approximately 90,000 to 180,000 people.

About Orphan Drug Designation

Orphan drug designation is granted by the FDA to encourage the development of treatments for diseases or conditions that affect fewer than 200,000 patients in the United States. Drug products that receive orphan drug designation obtain seven years of marketing exclusivity from the date of FDA marketing approval, as well as tax credits for clinical trial costs and waivers of marketing application filing fees.

About Jazz Pharmaceuticals, Inc.

Jazz Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on identifying, developing and commercializing innovative products to meet unmet medical needs in neurology and psychiatry. For further information, please visit http://www.JazzPharmaceuticals.com.

"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995

This press release contains forward-looking statements, including, but not limited to, statements related to the development program for the JZP-8 product candidate and the company's internal product concept generation program. These forward-looking statements inherently involve significant risks and uncertainties. Jazz Pharmaceuticals' actual results and the timing of events could differ materially from those anticipated in such forward- looking statements as a result of these risks and uncertainties, which include, without limitation, whether or when clinical studies of JZP-8 will be completed or will be successful, and whether or when the product candidate will be approved or launched. These and other risk factors are discussed under "Risk Factors," in the Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 filed by Jazz Pharmaceuticals with the Securities and Exchange Commission on November 9, 2007. Jazz Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.


'/>"/>
SOURCE Jazz Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
2. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
3. Quark Pharmaceuticals, Inc. Presented Positive Preclinical Results of Systemic RNAi Compound for Acute Renal Failure (ARF)
4. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
5. Sucampo Pharmaceuticals, Inc. Begins Pivotal Phase III Studies of Oral Lubiprostone to Treat Opioid-Induced Bowel Dysfunction (OBD)
6. Symbollon Pharmaceuticals, Inc. Evaluates the Clinical Effects of IoGen(TM) on Fibrocystic Breast Disease
7. Aegerion Pharmaceuticals, Inc. Presents Final Results of Phase II Clinical Trials for AEGR-733 at Drugs Affecting Lipid Metabolism (DALM) 2007 Conference
8. Keryx Biopharmaceuticals, Inc. Announces Positive Preliminary Phase 2 Data on KRX-0401 in Patients with Chemo-Insensitive Rare Sarcoma
9. Quark Pharmaceuticals, Inc. Announces First Systemic siRNA Dosing in Humans
10. Keryx Biopharmaceuticals, Inc. Announces Phase 1 and Phase 2 Data on KRX-0401 (Perifosine) in Patients with Relapsed/Refractory Multiple Myeloma at 49th Annual Meeting of American Society of Hematology
11. Solvay Pharmaceuticals, Inc. Responds to Advisory Committee Recommendation for Further Study of Tedisamil to Treat Atrial Fibrillation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/5/2016)... May 5, 2016 Progra m m ... of Oxitec , s mosquito in ... by 96 %   Oxitec ... plan to fight wild Aedes aegypti, the dangerous mosquito that spreads ... island of Grand Cayman .  MRCU, a global leader in ...
(Date:5/5/2016)... 5, 2016 ... of the  "Europe Thrombocythemia Market and ... to their offering.       ... ,The latest research Europe Thrombocythemia Market ... provides comprehensive insights into Thrombocythemia pipeline ...
(Date:5/4/2016)... Holdings (NYSE: CODI ) ("CODI," "we," "our" ... businesses, announced today its consolidated operating results for the ... Quarter 2016 Highlights , Generated Cash Flow Available ... $13.6 million for the first quarter of 2016; ... first quarter of 2016; , Paid a first ...
Breaking Medicine Technology:
(Date:5/5/2016)... Rafael, CA (PRWEB) , ... May 05, 2016 , ... ... of the Year, Derek Pittman, along with his university coaching staff. Together they bring ... girls, with separate sessions run for youth players ages 5-13, and high school players. ...
(Date:5/5/2016)... YORK, New York) , ... (PRWEB) May 05, 2016 , ... ... with healthcare talent acquisition startup, HireNurses, on the eve of National Nurses Week ... job seeking nurses and healthcare employers. With their enrollment into the Talent Tech Lab ...
(Date:5/5/2016)... ... , ... United Collection Bureau, Inc. (UCB) announces Sarah Clark as its new ... experience within the healthcare revenue cycle industry. With a primary focus of end-to-end revenue ... Services at Spectrum Health. While at Spectrum Health, Clark helped Spectrum achieve the HFMA ...
(Date:5/5/2016)... ... May 05, 2016 , ... The Lung Institute will celebrate its three-year ... seminar at most clinic locations throughout the month of May. To date, the Lung Institute ... rapid growth that we’ve seen is a testament to the success of this treatment and ...
(Date:5/5/2016)... ... May 05, 2016 , ... ... finalists and winners Tuesday evening, May 3, at the 2016 ISE® Central Executive ... Scott Pettigrew, Vice President and Chief Security Officer of HMS, was selected as ...
Breaking Medicine News(10 mins):