Trimel pharmaceuticals corporation (tsx: Trl)

Discussion in 'Men's Economics' started by Michael Scally MD, Oct 18, 2011.

  1. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    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.
     
  2. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Trimel Submits New Drug Application for CompleoTRT(TM) to FDA
    Trimel Submits New Drug Application for CompleoTRT(TM) to FDA - WSJ.com

    TORONTO, ONTARIO--(Marketwired - April 30, 2013) - Trimel Pharmaceuticals Corporation (TSX:TRL) (the "Company" or "Trimel") proudly announced today that the Company has submitted a New Drug Application ("NDA") to the United States Food and Drug Administration ("FDA") for approval of its bioadhesive intranasal gel testosterone product, indicated for the treatment of testosterone deficiency in men ("CompleoTRT(TM)"). The CompleoTRT(TM) NDA is supported by efficacy and safety results from 306 patients who participated in the pivotal Phase III study.

    "This NDA filing is an important achievement for Trimel," said Tom Rossi, President and Chief Executive Officer of Trimel. "If approved, CompleoTRT(TM) will provide men suffering from "Low T" with a novel treatment option. CompleoTRT(TM) is expected to offer hypogonadal patients the lowest efficacious delivered dose of testosterone in a convenient discreet device, without the risk for secondary transference."

    The Company expects the CompleoTRT(TM) NDA will be subject to a standard review by the FDA, which could be completed as early as the first half of 2014.

    About CompleoTRT(TM)

    Trimel's most advanced product candidate, CompleoTRT(TM), is a bioadhesive intranasal gel formulation of testosterone. CompleoTRT(TM) is designed with a view to providing hypogonadal patients with superior safety and enhanced convenience over currently available treatment options.

    Subject to FDA approval, CompleoTRT(TM) is designed to be applied to the interior lateral wall of the nasal cavity, where internal studies have demonstrated that the gel is fully absorbed into the nasal mucosa within 15-30 minutes. There is virtually no smell or taste associated with the gel. It is expected that, as a result of the "no touch" targeted delivery to the nasal mucosa, CompleoTRT(TM) should avoid skin-to-skin transference to spouses or other family members, a health risk that led the FDA to issue a "black-box" warning in May 2009 for secondary transference for all topical testosterone gel preparations.
     
  3. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    United States Food and Drug Administration Accepts Trimel's NDA for CompleoTRT(TM)
    United States Food and Drug Administration Accepts Trimel's NDA for CompleoTRT(TM) > Trimel Pharmaceuticals Corporation

     
  4. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Trimel Provides Update Regarding CompleoTRT(TM) FDA Review
    Trimel Provides Update Regarding CompleoTRT(TM) FDA Review - MarketWatch