Date Posted: 7 September 2020
4 September 2020
Drug Solution for Hypotonic Muscle Disorders.
Snoretox receives “Barrier to Innovation” Waiver from FDA (Center for Veterinary Medicine) for Innovative Medical Breakthrough Therapy.
Snoretox Pty Ltd has invented and patented modified Tetanus Toxins for hypotonic muscle conditions in both humans and animals, conditions such as sleep apnoea, sphincter laxity, myopathy, MND, MS, ectropion and other cosmetic indications.
The FDA CVM is the FDA’s veterinarian department, the cited indication is BOAS Syndrome in brachycephalic canines (essentially OSA in dogs), which reduces dog life expectancy by an average of 3 years, and has no known drug therapeutic option.
The FDA ‘s assessment criteria are
- Innovation: a drug must be highly innovative, novel, a medical break-through.
- Efficacy: Is there sufficient information for proof of concept in a validated in vitro system or in the target animal or an animal model of the target animal (e.g., laboratory rodent species)?
- Small-Medium Company: Is the company below $20 million in market size.
We were able to satisfy the criteria and examiners with a detailed application outlining the scientific evidence.
This success adds serious credibility to our dealings with the government, regulators and the market.
We would like to thank our USA FDA CVM Consultants Schafer and Associates for all their assistance and guidance to date and we also wish to thank RMIT University where the research was performed.
Kind regards,
Dr Anthony Sasse,
Managing Director, Snoretox Pty Ltd.
