Decision Resources, Inc., one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that acute sinusitis market is increasingly difficult to penetrate due to increasing regulatory demands, stiff generic competition, and significant formulary hurdles. According to the new report entitled Plethora of Generics and Heavy Hand of FDA Make This a Difficult Market to Enter: A Sinusitis (Acute) Study, an analysis of the leading therapies prescribed for acute sinusitis reveals that Johnson & Johnson's Levaquin offers a superior clinical profile even though it's reserved for later lines of therapy or more severe infections.
The FDA has been demanding increasingly stringent requirements for new drugs seeking approval for acute sinusitis. "Recent regulatory setbacks including Replidyne's faropenem and Oscient's gemifloxacin suggest that drug developers are facing greater regulatory scrutiny and demands for clinical efficacy and safety," said Danielle Drayton, Ph.D., analyst at Decision Resources. "So far, none of the drugs in development have shown better efficacy than currently available agents. Consequently, emerging therapies will find it difficult to gain FDA approval for the treatment of acute sinusitis."
About Plethora of Generics and Heavy Hand of FDA Make This a Difficult Market to Enter: A Sinusitis (Acute) Study
Plethora of Generics and Heavy Hand of FDA Makes This a Difficult Market to Enter: A Sinusitis (Acute) Study covers the current and future state of the acute sinusitis drug market. The report includes the following:
- More than 3,000 physician responses that define drug attributes that drive prescription now and in the future. - Clinical end point tradeoffs that are most influential to physicians. - Areas of unmet need with highest potential. - Benchmark trial results for specific drug opportunities. - Patient share potential for emerging therapies and target product profiles. - Decision Resources proprietary analysis of commercial factors that accelerate or constrain a drug's market potential. - Promotion: DTC spend, detailing intensity. - Reimbursement: formulary tier, prior approval restriction, quantity limits. - Labeling: black box warnings, approved patient segments, contraindications. - Competition: order of entry, pricing, generic entry, pipeline sales forecast. - Medical practice: decision trees, treating physician type, line of therapy. - Comparisons of the key clinical attributes of current and emerging therapies in the areas of efficacy, safety, and delivery. - Analysis and supporting data that identify the clinical "Gold Standard" now and over the next ten years. - Key insights as to which clinical end points have the greatest influence on physician decision-making.
The report can be purchased by contacting Decision Resources. Members of the media may request an interview with an analyst.
About Decision Resources
Decision Resources, Inc., (http://www.decisionresources.com/ ) is a world leader in market research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets.
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