Trimel Pharmaceuticals plans to present data from a recently completed Phase 2 “vibro-tactile stimulation (VTS) study” of its TBS-2 intranasal gel for the treatment of anorgasmia in women to the FDA at a meeting scheduled for November 2011. According to Trimel, in August 2011, it notified the CRO conducting the study that “patient enrolment would be considered complete on September 30, 2011 regardless of protocol mandated numbers” after receiving positive preliminary data.
The company said that it anticipates starting a Phase 2 ambulatory study in the US no later than early 2012 based on data from the VTS study. A Phase 1/2 study had previously “demonstrated positive downstream effects related to orgasm” in addition to clearance of the dose within the dosing period.
TBS-2 is a low-dose testosterone gel formulation that is delivered by a proprietary nasal applicator. Trimel anticipates that the intranasal formulation will prevent any transfer of testosterone to third parties.
Read the Trimel press release.
