Epitan: FDA intrigued by tanning drug
Wednesday, 12 November, 2003
Epitan (ASX:EPT) has returned from its pre-IND meeting with the US Food and Drug Administration with a clear idea of what will be required to get approval for US clinical trials, according to CEO Wayne Millen.
"It went very well and we're pretty excited about that," Millen said. "We now know what the pathway is to get into clinical trials in the USA."
Millen said the FDA was intrigued with Epitan's drug Melanotan, and its potential use to prevent skin damage from UV radiation.
The drug was tested in the US several years ago under a physician's IND on 90 patients; however, the company has further developed the drug and recently completed a Phase IIb trial in Sydney and Adelaide.
A trial of the recently developed sustained release implant formulation will begin on Monday in Queensland, Millen said, with results due in May next year. Once the data from the trial is available, the company will file an IND with the FDA.
"The IND trials will be done with the implant, so we need the data from this trial," Millen said. "We are confident that we will be able to get IND approval to start trials in the USA at a sophisticated and advanced level."
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