Ventrus Could Start Pivotal Trial For Rx Hemorrhoid Therapy Mid-Year
This article was originally published in The Pink Sheet Daily
Executive Summary
The novel 5HT2a receptor antagonist would be the first FDA approved therapy for acute, non-surgical hemorrhoids, though intra-anal steroids are prescribed off-label for symptomatic relief.
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Ventrus Biosciences Inc.
Like other start-up companies working to develop drugs for GI disorders, Ventrus Biosciences was attracted to the sector not only by unmet clinical needs and the focused sales opportunities, but also by the potential for creating a cross-over success: a drug that launches as a prescription product but eventually leaps over the counter to become a blockbuster, á la Claritin. Ventrus has two drug candidates ready for Phase III testing: a topical gel formulation of diltiazem, a generic vasodilator, as a treatment for anal fissures, and a novel compound it hopes will become the first new product approved for hemorrhoids in 30 years.
Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.
One Trial Plus Supportive Evidence Is Enough For Hospital-, Ventilator-Acquired Pneumonia Indication, Panel Says
Anti-Infective Drugs Advisory Committee members viewed one-trial as practical means of gaining efficacy data.