NEW YORK, March 1, 2013 (GLOBE NEWSWIRE) -- Ventrus Biosciences, Inc. (Nasdaq:VTUS) today announced the poster presentation of the results from its study investigating the quality of compounded topical 2% diltiazem hydrochloride formulations for anal fissures at the American Pharmacists Association Meeting currently underway in Los Angeles.
The use of topical 2% diltiazem hydrochloride for treating anal fissures has been explored in multiple clinical trials since 2000. In 2004, the Standard Practice Task Force of the American Society of Colon and Rectal Surgeons (ASCRS) published revised practice parameters for managing anal fissure and stated that topical formulations of calcium channel blockers may be appropriately used to treat anal fissure and accorded this practice parameter the highest level of evidence and highest grade of recommendation. Because no commercially manufactured version of topical 2% diltiazem has been approved by the US Food and Drug Administration (FDA) for treatment of anal fissure, colon and rectal surgeons, gastroenterologists, and other physicians who want to follow ASCRS practice parameters have to write prescriptions for a product that will be extemporaneously compounded by retail pharmacies. To examine the quality of compounded formulations of topical 2% diltiazem, Ventrus undertook a high-performance liquid chromatography (HPLC) analysis of preparations gathered from retail pharmacies in a metropolitan region.
A participating healthcare professional wrote 12 prescriptions, with 2 refills allowed per prescription, so that 3 prescriptions could be filled at each of 12 pharmacies (36 total refills) for compounded 2% diltiazem cream. The analysis included an assessment of potency (percentage of claim) and content uniformity, with sampling from 8 different pre-specified locations within the compounded formulation containers.The United States Pharmacopoeia (USP) standard for potency is 90% to 115% of claim. Of the 36 preparations, 5 (13.89%) were supra-potent and 13 (36.11%) were sub-potent. The supra-potent prescriptions ranged in potency from 117.2% to 128.5% of claim, and the sub-potent prescriptions ranged in potency from 34.8% to 89.8% of claim. Fourteen (38.9%) preparations lacked content uniformity according to the USP standard.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV