Futura Medical begins recruitment for erectile gel study

The AIM-traded firm said data from the PK study in 40 healthy subjects, which represented the initial step in Futura's Phase III programme for MED2002, would assist in determining the dosages to be used in two Phase III studies, which would begin next year “as soon as practicable” after the completion of the PK study.

Futura said the PK study would check the tolerance of subjects to a range of doses of MED2002, including higher doses than the dose used in the earlier efficacy study, and would also compare MED2002's safety profile against an approved angina treatment with the same active pharmaceutical ingredient.

The PK study would enable the exclusion of unacceptably high doses in the Phase III studies, Futura’s board explained, and provide additional safety data to support the proposed US regulatory pathway of a 505(b)(2) filing.

Subject enrolment in the PK study was expected to be completed early in the first quarter of 2018, and the results were expected to be available by the end of that quarter.

“The start of this PK study is of great significance for Futura as it marks the beginning of our Phase III programme for MED2002, our novel gel for the treatment of erectile dysfunction,” said Futura chief executive James Barder.

“By pre-screening formulations at a number of dosage strengths, the PK study will enable the Phase III studies to be run as expeditiously and cost effectively as possible.”

Barder said MED2002 had “huge potential” as a prescription medicine.

“This potential was highlighted by recent market research announced in October 2017, which found that more than 60 per cent of physicians in the US consider MED2002 to be an improvement over current ED therapies.”