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

HORMONE THERAPY FOR CRYPTORCHIDISM IS APPROPRIATE in-the short term before surgical procedures are employed, FDA's Endocrinologic and Metabolic Drugs Advisory Cmte. concluded at its June 24 meeting. Commenting on the use of a native GnRH or an LHRH analog as a first line corrective measure for maldescended testes, cmte. Chairman Frederick Singer, MD, Orthopaedic Hospital, Los Angeles, said that "it doesn't take very long in therapy, so I presume that there would be no great harm if surgeons admit that four weeks of hormone therapy is not going to make a big difference to a 12-month old baby." Emphasizing his support, cmte. member Michael Thorner, MD, University of Virginia, added: "From what I've heard and what I know, both from practice in Europe and reading the literature, my feeling is that (hormone therapyl is almost certainly safe and, secondly, that for the children who respond, it is extremely important and safe, and saves them from undergoing a lot of diagnostic procedures and undergoing unnecessary operations. Therefore, it should be seriously considered for approval at this point." In his introductory remarks to the cmte., FDAer Carlos Schaffenburg, MD, indicated that while safety associated with hormone therapy is not an issue, concerns nevertheless remain about the efficacy of treatment because proper patient stratification, specifically between those with retractile and non-retractile testes, is not always achieved. Invited speaker Jacob Rajfer, MD, University of California, noted the difficulty in making such a distinction when examining patients. Commenting on an appropriate diagnostic evaluation prior to the selection of therapy for cryptorchidism, Singer stated: "It seems to me that if this is an endocrine disorder and an anatomic disorder, then the diagnostic procedures should be a careful evaluation of the gonadotropins, etc., and if one gets what one might call a classic abnormality, one might consider therapy reasonable. On the other hand, if there is some borderline area, 1 think a biopsy is absolutely critical." Shaffenburg said researchers generally agree that there is a higher incidence of malignant tumor in the intra-abdominal testes, i.e. those which have not descended, and that eventually fertility is compromised. Addressing the question of whether the correction of chryptorchidism, which affects roughly 1% of the U.S. population, alters the prognosis in regard to fertility and malignancy, Singer responded, "I don't think the cmte. can answer the question. . ."

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