Perth-based SUDA (ASX: SUD), a drug delivery company focused on oro-mucosal administration, has received a Notice of Grant from the US Patent Office for patent application 13/445,331 entitled Buccal, Polar and Non-Polar Spray Containing Ondansetron'.
The company said the patent provides broad protection in the world’s largest pharmaceutical market for SUDA’s first-in-class oral spray formulation of ondansetron to treat nausea and vomiting induced by chemotherapy, radiotherapy and also in post-operative settings.
The patent has been granted or is pending in other major jurisdictions, it added.
According to SUDA, "Clinical studies have successfully demonstrated that the Company’s SUD-002 8mg spray is statistically bioequivalent to the commercially available 8mg ondansetron tablet. It is well tolerated and can be conveniently administered in multiple doses."
It continued, "...SUD-002 delivered statistically faster absorption versus the tablet as defined by median time to detectible drug levels of ondansetron."
The company said it is working with its US partner for SUD-002 to prepare for a meeting with the FDA to discuss the programme.
“We are delighted to have been granted this US patent covering our SUD-002 ondansetron spray for the treatment of nausea and vomiting in cancer and post-operative settings," said CEO, Mr Stephen J Carter. "This further validates our OroMist technology platform and our position as a leading company in the field of oro-mucosal drug delivery. We look forward to advancing SUD-002 towards a New Drug Application in the USA with our partner, Amherst Pharmaceuticals.”