Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50

Lupin wins FDA approval for Solosec as treatment of trichomoniasis

By Brian Buntz | July 1, 2021

LupinMumbai, India–headquartered Lupin Pharmaceuticals (NYSE:LUPIN) has received an expanded indication for Solosec (secnidazole) to cover the treatment of trichomoniasis in adult patients and their partners. 

The drug scored an initial FDA approval in 2017 for bacterial vaginosis (BV) in adult women. 

Solosec is now the only single-dose oral drug that has an FDA indication for both trichomoniasis and BV.  

The most recent approval follows a Phase 3 clinical trial that showed a 92.2% cure rate for patients with trichomoniasis, a common sexually transmitted disease (STD) resulting from infection with a protozoan parasite. CDC estimated there were two million trichomoniasis infections in the U.S. in 2018. Only about 30% of those with the condition, however, develop symptoms. 

In the Phase 3 trial mentioned above, clinical trial investigators reported no serious adverse events. Some 2.7% of drug recipients in the trial had vulvovaginal candidiasis and 2.7% had nausea. 

The infection, however, can lead to adverse health effects in women, including infertility, preterm birth and pelvic inflammatory disease. 

 


Filed Under: Drug Discovery
Tagged With: bacterial vaginosis, Lupin Pharmaceuticals, secnidazole, Solosec, trichomoniasis
 

Tell Us What You Think! Cancel reply

You must be logged in to post a comment.

Related Articles Read More >

Takeda Pharmaceutical in the Drug Discovery & Development Pharma 50
Takeda’s Takhzyro fares well in pediatric hereditary angioedema study
Novartis in the Pharma 50
Novartis to cut up to 8,000 positions
Gilead Sciences in the Drug Discovery & Development Pharma 50
Gilead resubmits application to FDA for twice-yearly HIV drug lenacapavir
George Floyd mural
How the pandemic and George Floyd made clinical trial diversity a priority

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Need Drug Discovery news in a minute?

We Deliver!
Drug Discovery & Development Enewsletters get you caught up on all the mission critical news you need. Sign up today.
Enews Signup
Drug Discovery and Development
  • MASSDEVICE
  • DEVICETALKS
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • MEDTECH 100
  • Medical Design Sourcing
  • Subscribe to our Free E-Newsletter
  • Contact Us
  • About Us
  • Advertise With Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2022 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Genomics/Proteomics
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • R&D 100 Awards
  • Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50