TRIMEL PHARMACEUTICALS CORPORATION (TSX: TRL) - Trimel Pharmaceuticals Corporation
Trimel is a vertically integrated specialty pharmaceutical company focused on improving the utility of known and successfully marketed pharmaceutical compounds by employing Localized Dosing Technologies (LDTs) that are specifically formulated and engineered to avoid the negative effects from first pass metabolism by the liver. These LDTs allow Trimel developed products to precisely target the delivery of medications thereby reducing side effects and improving patient outcomes over existing marketed products.
Compleo TRT - Hypogonadism ("Low T")
Trimel is developing Compleo TRT, an intranasal gel formulation of testosterone. Compleo TRT is designed to provide men with Low T with superior safety and enhanced convenience over currently available treatment options. Compleo TRT is applied to the interior lateral wall of the nasal cavity, where it is fully absorbed into the nasal mucosa within 10-15 minutes. It is expected that, as a result of the targeted delivery to the nasal mucosa using the unit dose applicator, Compleo TRT will avoid skin-to-skin transference to family members that has been the subject of an FDA boxed warning for existing topical gel preparations.
Current topical testosterone products became subject to a FDA boxed warning in May 2009, after the agency received reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products (secondary exposure). The ages of these children ranged from nine months to five years. Within the documented cases that the FDA had conducted full reviews, adverse events included inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age and aggressive behaviour. When using Compleo TRT, enhanced patient convenience may be derived from the ease of application, the lack of any mess or odour from the gel, as well as the convenient dosing via the intranasal applicator.
Compleo TRT has concluded a multi-center multi-staged Phase II Program. In the trials, Compleo TRT was dose to more than 100 patients over several weeks of treatment representing over 3,500 total doses. This series of studies provided support that Compleo TRT is safe and effective for the treatment of men with Low T. The Phase II trials met the established end point requirements of the FDA.
Compleo TRT should enter Phase III clinical trials in the second half of 2011.
Trimel is a vertically integrated specialty pharmaceutical company focused on improving the utility of known and successfully marketed pharmaceutical compounds by employing Localized Dosing Technologies (LDTs) that are specifically formulated and engineered to avoid the negative effects from first pass metabolism by the liver. These LDTs allow Trimel developed products to precisely target the delivery of medications thereby reducing side effects and improving patient outcomes over existing marketed products.
Compleo TRT - Hypogonadism ("Low T")
Trimel is developing Compleo TRT, an intranasal gel formulation of testosterone. Compleo TRT is designed to provide men with Low T with superior safety and enhanced convenience over currently available treatment options. Compleo TRT is applied to the interior lateral wall of the nasal cavity, where it is fully absorbed into the nasal mucosa within 10-15 minutes. It is expected that, as a result of the targeted delivery to the nasal mucosa using the unit dose applicator, Compleo TRT will avoid skin-to-skin transference to family members that has been the subject of an FDA boxed warning for existing topical gel preparations.
Current topical testosterone products became subject to a FDA boxed warning in May 2009, after the agency received reports of adverse effects in children who were inadvertently exposed to testosterone through contact with another person being treated with these products (secondary exposure). The ages of these children ranged from nine months to five years. Within the documented cases that the FDA had conducted full reviews, adverse events included inappropriate enlargement of the genitalia (penis or clitoris), premature development of pubic hair, advanced bone age and aggressive behaviour. When using Compleo TRT, enhanced patient convenience may be derived from the ease of application, the lack of any mess or odour from the gel, as well as the convenient dosing via the intranasal applicator.
Compleo TRT has concluded a multi-center multi-staged Phase II Program. In the trials, Compleo TRT was dose to more than 100 patients over several weeks of treatment representing over 3,500 total doses. This series of studies provided support that Compleo TRT is safe and effective for the treatment of men with Low T. The Phase II trials met the established end point requirements of the FDA.
Compleo TRT should enter Phase III clinical trials in the second half of 2011.
