Trimel Pharmaceuticals has received clearance from Australia's Therapeutic Goods Administration and has initiated patient enrolment in the country for the Tefina (TBS-2) Phase II ambulatory study exploring a "use-as-required" treatment for women experiencing female orgasmic disorder (FOD). Tefina is a no-touch bioadhesive intranasal low-dose testosterone gel being developed for the treatment of this disorder.
The double-blinded, placebo-controlled trial will involve premenopausal women experiencing FOD. Patients will receive Tefina or placebo at home instead of in a hospital setting. The primary efficacy endpoint will be the increase in the occurrence of orgasm over the treatment period compared against baseline levels. The company expects to complete this study by mid-2013.
The portion of the trial being conducted in the US was initiated in May, and is in the recruitment and dosing phase of the protocol. Trimel intends to enrol 240 patients in the study, with clinical sites in the US, Canada and Australia.
In addition, Trimel has entered into a letter of intent (LoI) with a European-based development partner to co-develop single- and fixed-dose combinations of a portfolio of a number of established compounds for the treatment of a variety of respiratory disorders utilising the company's unit dose dry-powder inhalation technology, TriVair. As part of this transaction, Trimel will gain rights to all know-how and intellectual property developed for territories outside of Europe, Russia and the Ukraine.
|Agreement Status:||New||Date Announced:||15 Oct 2012|
|Date Last Reported:||Duration:|
|Est Total Value:||Investment To Date:|
|Generic / Brand Name:||Tefina TBS-2 testosterone|
|Therapeutic Area:||Respiratory System|
|Indication:||Female sexual arousal dysfunction Respiratory disorders|
|Techonology/Field:||Drug delivery Drug development|