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"AmniScreen may offer reassurance to women concerned about unexplainedvaginal wetness during pregnancy. The product detects amniotic fluid leakagethat can lead to serious complications, such as infection and pretermlabor,(1)" says Nancy Jasper, MD, Assistant Clinical Professor, Department ofOb/Gyn, Columbia University, College of Physicians and Surgeons. "It'simportant for women to know when wetness may be caused by amniotic fluidleakage."
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In July 2006, Barr announced that it had entered into a development,manufacturing and supply agreement with Common Sense Ltd. for AmniScreen.Under the terms of the agreement, the Company agreed to make a one-timepayment to Common Sense following FDA approval.
Common Sense will manufacture and package the product and Duramed willdetail to physicians and healthcare providers. Barr will record net sales ofthe product and will pay Common Sense for product delivered.
How AmniScreen Works
AmniScreen works by detecting elevated pH levels, which may indicateamniotic fluid leakage.(2) Patients are instructed to report or show testresults to their healthcare provider for interpretation and medical care.(3)The pivotal trial demonstrated that AmniScreen detected amniotic fluid leakageabout 96% of the time.(4) During the trial, patient-read results andclinician-read results matched more than 97% of the time.(5)
Potential Candidates
Pregnant women who experience unexplained vaginal wetness are potentialcandidates for AmniScreen. Additional candidates include high-risk pregnantwomen, women who have undergone amniocentesis, have experienced prior amnioticleakage, and those who are concerned about unexplained wetness.
Safety Information
The AmniScreen Home Detection Liner Kit is intended to detect possibleleakage of amniotic fluid when vaginal wetness is experienced during pregnancyby indicating pH level. pH levels greater than or equal to 5.2 produce ablue-green color. Patients are instructed to report or show test results totheir healthcare provider for interpretation and medical care.
AmniScreen should not be used if less than 12 hours have passed sincesexual intercourse or vaginal douching. AmniScreen should not be used ifthere is vaginal bleeding or spotting. A healthcare provider should beconsulted if there is unexplained wetness, vaginal bleeding or spotting, orsuspicion of vaginal infection.
Marketing Agreement
Under a marketing agreement, Barr's proprietary subsidiary, DuramedPharmaceuticals, Inc., will launch AmniScreen immediately and will detail theproduct to physicians and healthcare providers with its Specialty andInstitutional Sales Forces. AmniScreen was developed by the privately-ownedcompany Common Sense, which was founded in 1999 and is a leading developer andmanufacturer of indicators utilizing common hygienic products such aspanty-liners and diapers as a platform for non-intrusive diagnosis and healthcondition monitoring.
About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical companythat operates in more than 30 countries worldwide and is engaged in thedevelopment, manufacture and marketing of generic and proprietarypharmaceuticals, biopharmaceuticals and active pharmaceutical i