ExcelMale
Menu
Home
What's new
Latest activity
Forums
New posts
Search forums
What's new
New posts
Latest activity
Videos
Lab Tests
Doctor Finder
Buy Books
About Us
Men’s Health Coaching
Log in
Register
What's new
Search
Search
Search titles only
By:
New posts
Search forums
Menu
Log in
Register
Navigation
Install the app
Install
More options
Contact us
Close Menu
Forums
Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
Testosterone Nasal Gel Product Gets Delayed by the FDA
JavaScript is disabled. For a better experience, please enable JavaScript in your browser before proceeding.
You are using an out of date browser. It may not display this or other websites correctly.
You should upgrade or use an
alternative browser
.
Reply to thread
Message
<blockquote data-quote="Excel Male" data-source="post: 5122" data-attributes="member: 1"><p>CompleoTRT, which was submitted to the FDA earlier last year, is Trimel's most advanced product candidate, and is a bio-adhesive intra-nasal gel formulation of testosterone, designed to provide hypogonadal patients with a better alternative to current treatment options. Male hypogonadism is a condition in which the body doesn't produce enough testosterone — the hormone that plays a key role in masculine growth and development during puberty — or has an impaired ability to produce sperm or both.</p><p>Last month, Trimel said that following recent discussions with the FDA, it decided that the most expeditious way to seek approval of its treatment was to proceed with a proposed three-times-a-day dosing protocol, requiring a change to its proposed label to exclusively reflect this dosing regimen. </p><p>At the time the decision was announced, on December 19, Rossi said: "The company continues to believe that a twice-per-day dose represents a promising alternative for patients with hypogonadism and we are considering options for pursuing approval for such a dosing regimen."</p><p></p><p><a href="http://www.proactiveinvestors.com/companies/news/51354/trimel-pharmaceuticals-sheds-as-fda-extends-target-date-for-testosterone-nda-51354.html" target="_blank">http://www.proactiveinvestors.com/companies/news/51354/trimel-pharmaceuticals-sheds-as-fda-extends-target-date-for-testosterone-nda-51354.html</a></p></blockquote><p></p>
[QUOTE="Excel Male, post: 5122, member: 1"] CompleoTRT, which was submitted to the FDA earlier last year, is Trimel's most advanced product candidate, and is a bio-adhesive intra-nasal gel formulation of testosterone, designed to provide hypogonadal patients with a better alternative to current treatment options. Male hypogonadism is a condition in which the body doesn't produce enough testosterone — the hormone that plays a key role in masculine growth and development during puberty — or has an impaired ability to produce sperm or both. Last month, Trimel said that following recent discussions with the FDA, it decided that the most expeditious way to seek approval of its treatment was to proceed with a proposed three-times-a-day dosing protocol, requiring a change to its proposed label to exclusively reflect this dosing regimen. At the time the decision was announced, on December 19, Rossi said: "The company continues to believe that a twice-per-day dose represents a promising alternative for patients with hypogonadism and we are considering options for pursuing approval for such a dosing regimen." [URL]http://www.proactiveinvestors.com/companies/news/51354/trimel-pharmaceuticals-sheds-as-fda-extends-target-date-for-testosterone-nda-51354.html[/URL] [/QUOTE]
Insert quotes…
Verification
Post reply
Share this page
Facebook
Twitter
Reddit
Pinterest
Tumblr
WhatsApp
Email
Share
Link
Sponsors
Forums
Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
Testosterone Nasal Gel Product Gets Delayed by the FDA
This site uses cookies to help personalise content, tailor your experience and to keep you logged in if you register.
By continuing to use this site, you are consenting to our use of cookies.
Accept
Learn more…
Top