Innovative Australian Drug receives Break-through Therapy “Barrier to Innovation” Waiver by the FDA CVM (USA Federal Drug Agency)
The FDA CVM is the FDA’s veterinarian department.
The 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, they do not give these out lightly.
This success adds serious credibility to our dealings with the government, regulators and the market.
SnoreTox Pty Ltd : Drug Solution for Hypotonic (Low tone) Muscle Disorders.
A RMIT University spin-off, we have produced modified Tetanus Toxins for Weak and Low Tone Muscle Disorders. They are revolutionary First-in-Class Pharmaceuticals.
There are no FDA approved drugs for increasing the tone and strength of skeletal and sphincter muscles for humans or animal usage. We have developed modified tetanus toxin molecules to achieve this end, to be called Tonetox (general use) and Snoretox (for snoring and sleep apnoea).
Botox was successfully developed to reduce muscle tone for cosmetic and medical purposes such as sphincter relaxation, muscle stiffness and spasms, and so it was considered that Tetanus toxin, a molecule that does the opposite of Botox, would have significant medical applications should a workable version be developed, a version that could avoid the vaccination-induced antibodies.
The innovative step is the cloning and production of modified tetanus toxin molecules to achieve that end, research performed at RMIT University over the last 10 years and supported by an ARC ran CVT and internal RMIT Grant funding.
The objective is to create a whole new market of treatment capability in the area of increasing muscle tone. Conditions resulting from low muscle tone include snoring, sleep apnoea, sphincter laxity (gastric reflux, anal and urinary incontinence), cosmetic conditions such as ectropion (lower eyelid laxity), eyelid lifting and facial muscle toning, pelvic floor and limb weakness, and neurological conditions of low muscle tone such as Motor Neurone Disease, MS, stroke and Myopathy in both in humans and animals. There are currently no drugs in this space.