Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



Executive Summary

FISONS SEEKING DESENEX PROPHYLACTIC CLAIM FOR ATHLETE's FOOT, according to recent correspondence between FDA and the company over a protocol to support the claim. "Our intent is to do a study for the powder dosage form of the current Desenex marketed product," Fisons Senior Regulatory Affairs Associate Joyce Miller told FDA. The company intends "to utilize this information, if positive, to support a prophylactic claim for all dosage forms currently marketed by Fisons," the regulatory affairs officer added. The company's suggested protocol to demonstrate the effectiveness of undeyclenates in the prevention of athlete's foot calls for a twelve-week, double-blinded parallel group clinical study. The medication will applied to all surfaces of the foot: toes and plantar surface. Test subjects are to have a history of athlete's foot, "defined as that elicited by questioning the patient wherein the patient by history has experienced two incidences of athlete's foot in the past 12 months and has previously experienced relief of signs and symptoms of their athlete's foot condition by use of over-the-counter medication." FDA has asked Fisons to further confirm a previous experience of athlete's foot in a test subject with a KOH preparation and culture of skin scrapings. Similarly, to evaluate effectiveness, equal weight will be placed on (1) signs and symptom scores and (2) KOH preparations and culture of skin scrapings. FDA has requested Fisons to "include a representative number of patients with a past history of interdigital as well as plantar type tinea pedis with the data analyzed for each subset and as a whole."

You may also be interested in...

Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts