CPAT-01 is an innovative cannabis-derived pain control for cats and dogs.
The waiver was granted under the significant barrier to innovation provision of the FDA’s Animal Drug User Fee Act (ADUFA) of 2003.
The waiver covers the current US$75,150 FY18 ADUFA sponsor fee which can be renewed each US fiscal year.
CannPal may also be eligible for reductions in other fees such as the drug application fee which can cost in excess of US$300,000.
The company was initially granted a fee waiver for an osteosarcoma pain treatment under the Minor Use/Minor Species (MUMS) pathway in 2017 which is a pathway that applies to diseases that affect a minor number of patients every year.
This new waiver under the barrier to innovation pathway is applicable to much broader indications, which allows CannPal to apply the waiver to CPAT-01D, which is being developed as a pain control in dogs.
CannPal plans to take the results from the recently commenced phase 1A and B studies to file an INAD (Investigational New Animal Drug) application with the FDA prior to the AU FY19 financial year, at which point the sponsor fee would be required to be paid.
CannPal founder and managing director Layton Mills said: “Receiving this fee waiver not only provides additional cost savings for the company but also further validates our focus on following regulatory protocol and seeking added value opportunities for our shareholders.
“The phase 1B study is now well underway and we are looking forward to continuing on our path of developing safe and scientifically-proven treatments for companion animals.”