No Sweat – Hyperhidrosis Patients Seek Broader Approvals; Botox Access An Issue

US FDA not looking to reduce attendance at third-party patient meetings, which deliver 'bang for the buck.' Excessive sweating is first externally led PFDD meeting for a more common condition.

Female athletes running towards finish line on track field

Drug sponsors interested in hyperhidrosis research and development should focus on treatments that are effective for all types of excessive sweating – not just underarm or foot/hand sweating, according to patients participating in a patient-focused drug development meeting hosted by the International Hyperhidrosis Society in Washington, DC on Nov. 13.

While there are treatments for hyperhidrosis approved by the US FDA – like Botox injections and DrySol prescription antiperspirant – they are not a realistic option for all areas where patients present with excessive sweating. Hyperhidrosis of the groin/buttocks or face/head are especially hard to treat, and off-label treatments are not always effective

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Approval Standards

US FDA Advisory Committee Misperceptions Abound … At HHS

 

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped

 

Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
• By 

Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.

More from Pathways & Standards

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By 

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum?

 
• By 

Sponsors reported faster development times for products that joined the pilot program intended to speed rare disease treatments in CBER.

Moderna Pivots To Increase Focus On Cancer Amid US Vaccine Policy Changes

 
• By 

During its first quarter earnings call, Moderna avoided criticizing vaccine policy changes, but de-emphasized its flu/COVID-19 vaccine for those under age 50 and prioritized cancer programs.