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

UsernamePublicRestriction
UsernamePublicRestriction

Zonagen/Schering-Plough Vasomax

Executive Summary

FDA places hold on clinical trials of Vasomax (phentolamine) pending analysis of data from a two-year rat carcinogenicity study, expected to be completed in the fourth quarter. Preliminary findings show a high proliferation of "brown fat" in the rats. A fully enrolled, 12-week Schering study of Vasomax for erectile dysfunction has been permitted to continue. Another proposed 12-week Schering study and a Zonagen Phase II trial of phentolamine for female sexual dysfunction are being placed on hold. The companies anticipate the hold will cause a six-month delay in regulatory filing

You may also be interested in...



Schering/Zonagen end Vasomax agreement

Schering-Plough and Zonagen mutually terminate worldwide licensing agreement for experimental oral erectile dysfunction therapy Vasomax and other phentolamine-based technologies, Zonagen announces July 15. The decision coincides with the submission of final results from a one-year mechanistic study of phentolamine-induced brown fat proliferations in rats, which Zonegan maintains show no effect. The study was designed to allay FDA's concerns raised by an earlier two-year rat carcinogenicity trial; FDA deemed Vasomax "not approvable" in May 1999 and subsequently placed the drug on clinical hold (1"The Pink Sheet" Aug. 16, 1999, p. 32)...

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

UsernamePublicRestriction

Register

PS034698

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

Cancel