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Re: OB: Mixed Reviews On Drug To Prevent Preterm Birth From: LCLEMOS@aol.com Tue Aug 29 18:21:31 2006 Messages sorted by: [ date ][ thread ][ subject ][ author ] Next message: Dean Huffman .: "Off Topic, But Interesting ..." Previous message: Larry Glazerman: "RE: OB:  What would you do" Maybe in reply to: Dean Huffman .: "OB: Mixed Reviews On Drug To Prevent Preterm Birth" Next in thread: Len2976@aol.com: "Re: OB: Mixed Reviews On Drug To Prevent Preterm Birth" In a message dated 8/29/2006 6:54:07 P.M. Eastern Standard Time, dean@thehuffpeople.net writes: , The article does not mention the generic name of the drug. It only mentions "Gestiva". Do you know the identity (i.e., generic name) of Gestiva? I presume this refers to the NEJM article, and others, and ACOG Committee Opinion 291 concerning the use of 17 alpha hydroxyprogesterone caporateto prevent preterm birth. Is that what Gestiva is, or is Gestiva something else? yup, it appears to be although even their news release from May doesn't specifiy exact composition....: _http://phx.corporate-ir.net/phoenix.zhtml?c=182397&p=irol-newsArticle&ID=852616&highlight_ (http://phx.corporate-ir.net/phoenix.zhtml?c=182397&p=irol-newsArticle&ID=852616&highlight) = Adeza Submits New Drug Application For Gestiva to Prevent Preterm Births; NIH Study Finds 34% Reduction in Preterm Births; Therapy Recommended by ACOG SUNNYVALE, Calif.--(BUSINESS WIRE)--May 4, 2006-- Conference Call to Discuss Gestiva and First Quarter Financial Results Begins at 4:30 p.m. Eastern Time Today Adeza (NASDAQ:ADZA) today announced the submission of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Gestiva(TM), the company's drug candidate to prevent preterm birth in women with a history of preterm delivery. Adeza has requested Priority Review for the Gestiva NDA that, if granted, would set a six month goal for review by the FDA. Adeza has also submitted an application to the FDA requesting Orphan Drug designation. Gestiva is a long-acting, naturally occurring form of progesterone. If Gestiva is approved, Adeza will have the only commercially available, NIH-studied, ACOG-recommended and FDA-approved therapeutic for the prevention of recurrent preterm birth. <snip>OB/GYNs are beginning to use this form of progesterone in women with a history of prior preterm birth based on a 2003 American College of Obstetricians and Gynecologists (ACOG) recommendation that followed an NIH study published in the June 2003 New England Journal of Medicine. Currently, this form of progesterone is prepared solely by compounding pharmacies. Subject to approval, Gestiva will be widely available and manufactured under strict FDA requirements," said Durlin E. Hickok, MD, vice-president, medical affairs. "Preterm birth is a major health problem and Adeza is excited about the opportunity to help infants and families." Background to Gestiva Adeza's NDA submission for Gestiva includes data from a clinical study conducted by the National Institute of Child Health and Human Development, one of the institutes of the NIH. The NIH studied a long-acting form of a naturally occurring progesterone, 17 alpha-hydroxyprogesterone caproate (17P), in a multi-center, double-blind, placebo-controlled trial that enrolled 463 women with a prior history of preterm birth. Patients were enrolled at 16 to 21 weeks of gestation and randomly assigned to receive weekly injections of 17P or placebo. Treatment continued until delivery or 37 weeks of gestation, resulting in a reduction in the preterm birth rate of 34% among women treated with 17P. In addition, infants born to women treated with 17P had significantly lower rates of necrotizing enterocolitis, intraventricular hemorrhage, use of supplemental oxygen, and mean number of days of respiratory therapy. Next message: Dean Huffman .: "Off Topic, But Interesting ..." Previous message: Larry Glazerman: "RE: OB:  What would you do" Maybe in reply to: Dean Huffman .: "OB: Mixed Reviews On Drug To Prevent Preterm Birth" Next in thread: Len2976@aol.com: "Re: OB: Mixed Reviews On Drug To Prevent Preterm Birth"

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