Transdermal Delivery Solutions said today the clinical trial of its Testagen Hypospray has entered its pivotal phase.
The Testagen TDS is designed for testosterone replacement through transdermal absorption through a spray-on delivery system.
“We are pleased to reach this milestone and expect our progress with the technology to accelerate rapidly from here. As with any drug delivery FDA-approval process, it’s been a long road of regulatory channels over the course of its development. It’s exciting to begin this final stage of testing with TDSC,” prez Kenneth Kirby said in prepared remarks.
The initial studies look to establish an ideal initial dose range for further studies and to validate earlier research on the device. The company expects to receive approval for the clinical trial in 60-days or less and begin screening for patients immediately.
TDS said it hopes the studies will be completed over the next 3 months.