Botanix Pharmaceuticals shares surge after BTX 1801 gets US FDAs Qualified Infectious Disease Product status

By Deputy Chief EditorApril 24, 2020

175 1 minute read

Botanix Pharmaceuticals Ltd (ASX:BOT) has received the Qualified Infectious Disease Product (QIDP) status for its antibacterial product BTX 1801 from the US FDA.

BTX 1801 is a novel topical formulation of cannabidiol which utilises Botanixs proprietary skin delivery technology, Permetrex, to target bacterial infections in the skin.

The QIDP status entitles BTX 1801 an extra five years of valuable FDA exclusivity, as well as eligibility for fast-track status and priority FDA review.

This is a significant milestone for Botanix as BTX 1801 is the first cannabinoid-based program to receive the designation globally and represents a strong endorsement of Botanixs data.

Potential to prevent post-surgical infections[hhmc]

Botanix president and executive chairman Vince Ippolito said: “Botanix is extremely proud to

receive QIDP status from the FDA.

“This achievement is built on the back of solid pre-clinical research that demonstrates to the FDA that BTX 1801 has the potential to prevent post-surgical infections.

“We also look forward to continuing our work with the FDA to submit our application for fast-track

status during this quarter, with the hope of accelerating the path to market for this product.

“Antibiotic resistance is putting increasing pressure on our healthcare system, so our goal is to reduce infection rates and improve patient outcomes.”