Benzinga | Dec 9, 2020 09:40AM EST

Citius Pharma Reports Receives FDA Response, Guidance To Pre-Investigational New Drug Consultation Submission For Mino-Wrap

Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced its receipt of a written response and guidance from the U.S. Food and Drug Administration (FDA) Division of Anti-Infective Products to the Company's Pre-Investigational New Drug (Pre-IND) consultation request for its Mino-Wrap briefing package. Through its global license agreement with the The University of Texas MD Anderson Cancer Center, Citius is developing Mino-Wrap, a novel approach to reducing post-mastectomy infections associated with the use of a tissue expander. The briefing package contained information regarding pre-clinical data and a clinical development plan, along with questions for the FDA regarding safety and efficacy data that would be required to advance Mino-Wrap into clinical trials.

The FDA granted a Written Response Only meeting regarding guidance and direction on the Mino-Wrap development plan. The agency indicated that bio absorption simulation studies may provide information to support the development of Mino-Wrap and made suggestions on what should be provided relative to non-clinical support. The FDA provided guidance on the design of the drug elution studies and agreed that a large animal pharmacology study would be appropriate. They also agreed that a 28-day toxicology study appears appropriate and that microbiology support through existing data is acceptable.

"The FDA provided us with valuable guidance and confirmed a number of our initial plans on the development of Mino-Wrap," said Myron Holubiak, President and CEO of Citius Pharmaceuticals. "We are very pleased to have guidance support from the agency because this is such an under-recognized problem, and current preventative measures have not yielded very acceptable results. We think we have an important innovation for the prevention of post-operative infections associated with breast reconstructive surgery after mastectomies."