I don’t want to get drawn too much on timings, because we haven’t as yet discussed the results with the regulatory authorities, but we have taken regulatory advice since the results came out and we think there is the possibility for an expedited review with, actually, a lower level of data
Ken James, Futura's head of R&D
So, tell us about the company
In the case of its lead product, MED2005, the payload was glyceryl trinitrate (GTN), normally used to treat heart failure and high blood pressure. Futura combined the two to create a rapid onset gel that tackled erectile dysfunction.
Results from a phase III clinical trial of MED2005 surprised in a way not envisioned by researchers. However, as we’ll see below, rather than being a disappointment, the outturn could make it easier for Futura to get a product to market.
The company is also developing TPR100, which utilises DermaSys to deliver diclofenac, a painkiller and anti-inflammatory usually taken in pill form.
Phase III trial
The December 10 update delivered what can best be described as a set of nuanced results. For while MED2005 (DermaSys + GTN) showed strong efficacy, excellent safety, rapid speed of onset, the placebo had a “highly statistically significant” impact on the men in the control group of the experiment.
Normally, a placebo is a sugar pill, liquid or gel with no medical benefit whatsoever. However, in the Futura clinical assessment, researchers used DermaSys as the supposed inert substance. As Futura said the results from the control group were highly statistically significant, this would tend to rule out a small lift sometimes observed called the placebo effect.
The outcome meant that while MED2005 scored well on most trial elements (efficacy, safety, and speed of onset), it failed to meet its clinical endpoint of being statistically superior to the placebo gel.
That’s not to say the trial, or the technology was a failure. According to Futura, its regulatory submission has become simpler thanks to the rather odd outcome. For instead of submitting the MED2005 combination for scrutiny by the watchdogs, the firm intends to submit just the DermaSys part of the formulation for approval. In doing so, it will put DermaSys forward as a medical device rather than a pharmaceutical product.
Why as a medical device? Well, the results from DermaSys-only cohort showed the men involved responded to a mechanical and physical effect rather than to the chemical substance GTN.
That mechanical and physical effect on the body means DermaSys conforms to the definition of a medical device rather than a drug.
“The device regulations, generally speaking, are less arduous than the drug regulations,” said Ken James, Futura’s head of R&D in a recent interview with Proactive’s Andrew Scott.
“It tends to be a faster time-frame to approval. I don’t want to get drawn too much on timings because we haven’t as yet discussed the results with the regulatory authorities, but we have taken regulatory advice since the results came out and we think there is the possibility for an expedited review with, actually, a lower level of data.”
In April Futura said that it had been asked by the US FDA to attend a second meeting to discuss steps to get the product, now known as MED3000, approved as a medical device rather than a drug.
That meeting will discuss clinical sufficiency and/or post-marketing requirements once the clinical study report or CSR for the FM57 study is available.
If successful, this could lead to a US submission filing in the third quarter of this year for pre-marketing clearance,
What the boss says: James Barder, chief executive
“Futura remains in consultation with the FDA regarding overall data requirements as we move towards targeted regulatory submissions for MED3000 in both the US and EU in the next six months.”
"In Europe, formal proceedings are now underway for approval with the CSR expected to be submitted to the appropriate body by July,"
- Second meeting with the US FDA
- Submission of MED3000 for US approval
- CSR submitted to regulatory authorities in Europe