Patient-Focused Drug Development: We Shape the Future

Comment Now & Help Create the Progress We Need

We are so proud and thankful to the entire hyperhidrosis community for coming together and making the Patient-Focused Drug Development (PFDD) meeting in Washington, D.C. a huge, beyond-all-expectations success! 

EVERYONE who has participated so far has played an integral role in this monumental journey that we are determined will take us from surviving hyperhidrosis to thriving in life.

If you haven’t joined this effort yet, or if you’re ready to do more, know this: 

The Patient-Focused Drug Development process for hyperhidrosis is not over! 

Input and support from all of us will shape the future of hyperhidrosis care. 

PFDDs are an important way for us to make our voices and needs heard by treatment developers, healthcare providers, and the U.S. Food and Drug Administration (FDA). PFDDs started as FDA-led events, but recently organizations like the International Hyperhidrosis Society have been able to apply to host them, with representatives from the FDA and key treatment developers opting to attend and listen.

Here’s how we’ve all made the hyperhidrosis PFDD special already:

  • Involvement: With 125 participants at the November 13th meeting and 350 following it live via webcast, the FDA’s Dr. Kendall Marcus noted that the hyperhidrosis PFDD meeting was "potentially a record-breaker.”
  • Firsts: The Hh PFDD is the first externally-led PFDD for a “more common” condition, and the first externally-led PFDD for a dermatologic condition.
  • Art in Action: Prior to the PFDD meeting on November 13th, we gathered with 95 hyperhidrosis patients and their loved ones to create a display piece illuminating the hyperhidrosis experience. It is a unique and powerful monument to the courage and resilience of Hh sufferers. View slides of the creative process and the art itself here.

    (If you didn’t attend the PFDD meeting in D.C. or felt that there was more you wanted to say, the microphone is still on! Join the comment period by sending an email until Jan. 13, 2018 and watch the hyperhidrosis PFDD’s video and slideshow anytime. )

This PFDD process has been extremely productive so far! Keep up the good work! Here’s just some of the feedback we’ve received since November 13, 2017:

“I would like to congratulate you and your team on a very successful, well-conducted and informative meeting! I learned much about hyperhidrosis yesterday, including important information about… patient impacts, lack of awareness within the medical community, lack of access to quality care for some patients, the limitations of available treatments, barriers in access to treatment, and the need for additional pathways for drug development that could result in wider availability of treatments for patients.” 

– Dr. Kendall Marcus, Director, Division of Dermatology and Dental Products, FDA


“On behalf of all of our FDA colleagues, we want to thank all of those suffering with hyperhidrosis and family members who so eloquently and courageously shared their experiences… The strength and determination these families have continuously demonstrated is inspiring, and we are incredibly grateful for the opportunity they provided us in sharing their stories.” 

– Meghana Chalasani, Analyst at FDA's Center for Drug Evaluation and Research

I have never met so many Hh champions in one setting and was so grateful to meet others just like me and hear their stories.”

– Patient panelist


“This weekend had such a huge impact on my life and I feel so empowered because of it.” 

– Patient audience participant


“Thank you for giving me hope after 47 years!" 

– Patient webcast participant


“I haven’t received any treatment yet, but I feel like the healing has begun.” 

– Patient audience participant


But there is still so much to be done. In a survey of PFDD participants we found that:

  • 95% say their hyperhidrosis is NOT resolved
  • 70% are DISsatisfied with healthcare provider knowledge of Hh.

We’re shaping our future through this PFDD and have ONE MONTH REMAINING in our public comment period. To comment, just send an email with the subject line “PFDD Comments.”

  • What types of new treatments do we need?
  • What recommendations should we make for clinical trial endpoints or measurements? What could be a measurable data point to determine if a treatment is working?
  • What are the downsides to current treatment options

Thank-you to the FDA for initiating the invaluable PFDD platform. And a HUGE thank-you to all who participated in the PFDD in-person, online, and through commenting so far. 

Public commenting closes on January 13, 2018. Send your email now and be a part of hyperhidrosis history, as well as the future. 

Reports and additional materials to follow. 

Stay tuned also for information about another exciting live event to be held during Hyperhidrosis Awareness Month November 2018 – we hope you’ll join us to honor our 15th year of service!

We thank the generous support of Dermira, RA Fischer, Brickell Biotech, Hidrex USA, and private donors for making the landmark hyperhidrosis PFDD initiative possible.


Print   Email