Notice: Function _load_textdomain_just_in_time was called incorrectly. Translation loading for the wordpress-seo domain was triggered too early. This is usually an indicator for some code in the plugin or theme running too early. Translations should be loaded at the init action or later. Please see Debugging in WordPress for more information. (This message was added in version 6.7.0.) in /var/www/html/wp-includes/functions.php on line 6260 FDA Accepts Allergan and Paratek's Joint NDA | Contract Pharma

What are you searching for?

Sign in
Breaking News, Collaborations & Alliances, Trials & Filings

FDA Accepts Allergan and Paratek’s Joint NDA

For Seysara (sarecycline) for the treatment of moderate to severe acne

By: Betsy Louda

, Contract Pharma

Allergan and Paratek Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) to review Seysara (sarecycline) for the treatment of moderate to severe acne vulgaris in patients 9 years of age and older. Seysara is a once-daily, oral, narrow spectrum tetracycline-derived antibiotic with anti-inflammatory properties for the potential treatment of moderate to severe acne in the community setting.

 

“The FDA’s NDA acceptance is encouraging as results shown in the Seysara (sarecycline) Phase 3 trials involving 2,002 patients demonstrate that Seysara, if approved, has the potential to be a new, effective, safe and well-tolerated treatment option for physicians treating patients with moderate to severe acne,” said Evan Loh, MD, president, chief operating officer and chief medical officer of Paratek.

 

The application includes two identically-designed, large, multicenter, randomized, double-blind, placebo-controlled, Phase 3 studies, which demonstrated that once-daily sarecycline 1.5 mg/kg significantly improved acne severity based on Investigator’s Global Assessment (IGA) success and significantly reduced inflammatory lesion count vs placebo at week 12 in patients with moderate to severe facial acne vulgaris. In March 2017, Allergan announced positive results of these Phase 3 studies, which met their primary efficacy endpoints.

 

Add us as a preferred source on Google

Get the latest Contract Pharma news, insights and analysis in your Google Search and AI experiences.

Add Contract Pharma as a preferred source on Google (opens in a new tab)

Keep Up With Our Content. Subscribe To Contract Pharma Newsletters

Topics