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NexMed Defends Vitaros: The Candid Approach

 
• By Cole Werble

July 23 was a challenging day for NexMed's lead product (Vitaros, a cream formulation of alprostadil for erectile dysfunction) and, by extension, for its platform technology (the NexACT permeation enhancer). That was day the company had to explain an FDA "not approvable" letter. The FDA decision undercut the safety image that NexMed had been proclaiming for its permeation enhancer. NexMed's forthright discussion of its problems may be a model for the new era of complete response letters.

As recently as two weeks before the Food & Drug Administration sent NexMed Inc. a "not approvable" letter, the company touted its drug delivery ingredient as "powerful" and "safe" with over 100 animal studies to support it. The combination of attributes, NexMed said, would set NexACT—the platform technology used in Vitaros—apart form other drug delivery technologies.

NexMed had openly proclaimed July 19, the user fee deadline date for Vitaros, as a day of reckoning: "the day we should know the fate of this product," the company...

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Ocaliva: Still No Clarity On Why EU Court Opposed Revocation Of Approval

 
• By Neena Brizmohun

Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By Nielsen Hobbs

This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By Nielsen Hobbs

We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.

Brazil Pilots Digital Drug Pack Inserts

 
• By Francesca Bruce

A new pilot aims to take Brazil closer to ‘digital transformation.’

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Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.