Trimel Pharmaceuticals' Female Sexual Dysfunction Program Achieves Key Milestones
- Results of TBS-2 Phase II Vibrotactile Stimulation study yield positive outcomes for all Anorgasmia parameters
- Company to initiate multinational TBS-2 Phase II Ambulatory clinical program
- Dialogue with the United States Food and Drug Administration together with qualitative patient research has produced refined selection criteria and efficacy metrics for TBS-2 Phase II Ambulatory study
-TEFINA(TM) filed with United States Patent and Trademark Office as TBS-2 trade name
TORONTO, ONTARIO--(Marketwire -02/14/12)- Trimel Pharmaceuticals Corporation (TSX: TRL.TO - News) ("the "Company" or "Trimel") today announced the achievement of key milestones furthering the development of its no-touch bioadhesive intranasal gel product Tefina (TBS-2) for the treatment of Female Anorgasmia:
Tefina™ Phase II Vibrotactile Stimulation Study (VTS) Results
The Company announced today that the results from the Vibrotactile Stimulation (VTS) study demonstrated that Tefina had successfully met all study endpoints.
The VTS study measured the occurrence of, time to reach, and the quality of the orgasm, as compared to placebo. On the key metric of achieving orgasm, the results indicate that the separation between placebo and active drug demonstrates a significantly positive finding for Tefina. The VTS study further investigated improvements in the key measures of sensuality, sexual arousal and genital sensation. For all the metrics listed, Tefina again demonstrated a meaningful separation from placebo.
Tefina™ Phase II Multinational Ambulatory (AMB) Study.
Given the successful outcome from the VTS study, the Company expects to move expeditiously to implement its second Phase II study of Anorgasmia. This upcoming clinical study will be one of the largest to ever explore a "use as required" treatment for women experiencing any form of Anorgasmia.
Tefina™ Regulatory Update
Based on a cooperative dialogue with the US Food and Drug Administration (FDA), the Company has executed an extensive qualitative research program with women experiencing Anorgasmia. The findings of this research has provided supportive evidence that has been integrated into the patient selection and endpoint measurement criteria that will be implemented in the Phase II AMB Study.
TBS-2 Tradename - Tefina™
The application to the United States Patent and Trademark Office for the trademark "Tefina" underscores the Company's belief in trade marking a product once it has demonstrated safety and efficacy through a Phase II trial.
Bruce D. Brydon, Chairman and Chief Executive Officer of Trimel, offers the following comments "The positive conclusion of the Phase II VTS study along with its predecessor programs denotes ground breaking support for our decision to pursue a "use as required" product for women experiencing Anorgasmia. These pioneering insights in female sexual health, where to date no "use as required" product has been approved, gives even greater importance to our corroborative effort with the FDA to improve diagnostic criteria and assistive measurements for implementation in our Phase II AMB study. Implementing these principles is expected to provide a more efficient continuum along the pathway to product approval.
