TORONTO, ONTARIO--(Marketwired - Jul 9, 2013) - Trimel Pharmaceuticals Corporation (TRL.TO) today announced that the New Drug Application ("NDA") for its bioadhesive intranasal gel testosterone product ("CompleoTRT") has been formally accepted for review by the United States Food and Drug Administration (the "FDA"). The NDA is supported by efficacy and safety results from 306 patients who participated in the pivotal Phase III study.
Additionally, the FDA has confirmed that under the United States Prescription Drug User Fee Act, the NDA will be subject to a standard review and the target action date for the NDA is February 28, 2014.
About CompleoTRT
Trimel's most advanced product candidate, CompleoTRT, is a bioadhesive intranasal gel formulation of testosterone. CompleoTRT 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 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 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.
About Trimel
Trimel is a specialty pharmaceutical company actively developing medications for male hypogonadism, female sexual dysfunction and various respiratory disorders. An NDA for CompleoTRT, a product utilizing Trimel's licensed bioadhesive intranasal gel technology, has been accepted for review by the FDA for regulatory approval in the United States. For more information, please visit http://www.trimelpharmaceuticals.com.
Notice regarding forward-looking statements:
Information in this press release that is not current or historical factual information may constitute forward looking information within the meaning of securities laws. Implicit in this information are assumptions regarding our future operational results. These assumptions, although considered reasonable by the Company at the time of preparation, may prove to be incorrect. Readers are cautioned that actual performance of the Company is subject to a number of risks and uncertainties, including that CompleoTRT may not be approved by the FDA or that any approval may be delayed, and could differ materially from what is currently expected as set out above. For more exhaustive information on these risks and uncertainties you should refer to our prospectus dated April 18, 2013 which is available at http://www.sedar.com. Forward-looking information contained in this press release is based on our current estimates, expectations and projections, which we believe are reasonable as of the current date. You should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While we may elect to, we are under no obligation and do not undertake to update this information at any particular time, whether as a result of new information, future events or otherwise, except as required by applicable securities law.
See the article here:
United States Food and Drug Administration Accepts Trimel's NDA for CompleoTRT(TM)
- Causes of Low Libido - Could It Be Low-T? - May 30th, 2022
- The Evolutionary Effects of Testosterone on Human Society - September 20th, 2021
- More Sex: A Better Way to Boost Your Testosterone Levels - September 7th, 2021
- Men Want to Know – Free Testosterone versus Total Testosterone - August 24th, 2021
- What is testosterone? - May 23rd, 2021
- Tribulus Terrestris Review Does It Raise Testosterone or ... - May 22nd, 2021
- Boosting testosterone levels (First of two parts) - May 8th, 2021
- How long does it take for Testosterone replacement treatments and therapy to work? - May 1st, 2021
- What Is Testosterone AndroGel - April 28th, 2021
- Low T - My life was falling apart because I had low testosterone - April 25th, 2021
- Deer Antler, HGH and Testosterone: Tim on Scott and BR Radio Show - Video - April 17th, 2021
- What is Testosterone? What does Testosterone do? Find on - April 14th, 2021
- How Testosterone Affects the Skin of Men - April 11th, 2021
- Testosterone, the Power Hormone - April 8th, 2021
- Testosterone Levels and Wall Street - March 27th, 2021
- Women can resist testosterone-fuelled political debate - March 12th, 2021
- BUSTED: Myths About Testosterone And Its Link To Sexual Desire In Men And Women - March 11th, 2021
- Attention Baby Boomers -- Could Testosterone be the Modern Day "Fountain of Youth?" - March 4th, 2021
- Declining Testosterone Levels in Men Not Part of Normal Aging - February 28th, 2021
- Quick Weight Loss Tips and Diet Recommendations for HRT - February 28th, 2021
- Testosterone and Alcohol: Your Health and the Holiday Season - February 27th, 2021
- Testosterone builds muscle but has risks - February 25th, 2021
- New Study Finds That Testosterone Does Not Increase Cardiovascular Risk - February 22nd, 2021
- Evidence Suggests Testosterone Plays Powerful Role in Motivating Revolutionary Change - February 15th, 2021
- The Effects of Parenthood Upon Testosterone Levels - January 9th, 2021
- Testicular Cancer Survivors are at Risk for Low Testosterone - January 6th, 2021
- Amygdala and it's Relationship to Testosterone and Fear - December 25th, 2020
- Testosterone Does Not Cause Atherosclerosis (Hardening of the Arteries) in Older Men - December 24th, 2020
- Increased Testosterone DOES NOT Cause Prostate Cancer to Spread - December 23rd, 2020
- Testosterone Cypionate and Testosterone Enanthate: The Real Facts - December 20th, 2020
- A Surprising Side Effect of Methadone Treatment: Suppressed Testosterone - December 18th, 2020
- The Testosterone Industry Globally is Booming - December 12th, 2020
- Five Benefits of Testosterone That You Need to Know - December 11th, 2020
- Testosterone Nasal Gel: A New Form of Testosterone Replacement Therapy - December 5th, 2020
- New Research Proves Testosterone Replacement Therapy is Safe for the Heart - December 3rd, 2020
- Skinny Bartender with Low Testosterone Becomes a Ripped Bodybuilder - December 3rd, 2020
- Low-T and Your Health - November 30th, 2020
- Low Testosterone Levels may Affect Man's Sex Drive and Affect his Intimate Relationships - November 19th, 2020
- Is Testosterone the New Drug of Choice on Wall Street? How Traders are Using Male Hormone Booster Shots to Maintain a ... - November 12th, 2020
- Shorter course of ADT for high-risk prostate cancer patients yields improved quality of life - November 11th, 2020
- Testosterone Litigation: What You Need To Know - MTMP - Video - November 9th, 2020
- Methadone Lowers Testosterone in Men Only - November 8th, 2020
- Intricate relationship between Oestrogen & Testosterone XXY Guys (Klinefelters' syndrome) - Video - November 7th, 2020
- Should middle-aged men consider 'low T' treatment? - November 5th, 2020
- Testosterone and Crime: What Can Genes Tell Us About Behavior? - Video - October 25th, 2020
- Testosterone shown to help sexually frustrated women - October 22nd, 2020
- Testosterone levels seen prior to birth in fetus' fingers, jawline - October 20th, 2020
- Tri-Blend Testosterone. Understanding the Benefits of Testosterone Oils - October 19th, 2020
- Testosterone levels in older men - October 17th, 2020
- Tlando Testosterone Clinical Trial for Low-T and Fatty Liver Disease - October 4th, 2020
- Testosterone Focus in Diabetes Study – Video - September 30th, 2020
- Testshock Review All Natural Testosterone Enhancement – Video - September 30th, 2020
- Testosterone, Anxiety, and Depression - September 30th, 2020
- Average Testosterone Levels Decreasing Over Time Among Younger American Men - August 21st, 2020
- Testosterone Creams for Low Testosterone Treatment and Andropause - August 10th, 2020
- Testosterone Therapy and Androgen Deficiency Guide - August 6th, 2020
- Testosterone's Surprising Link to Men's 'Love Hormone' Oxytocin - August 5th, 2020
- Fortesta Brand Testosterone Therapy - August 3rd, 2020
- Andropause: Age-Associated Testosterone Decline - August 1st, 2020
- How to Build Muscle Quickly by Boosting Testosterone Levels - July 29th, 2020
- Testosterone Deficiency Strongly Linked to Heart Attack Risk in New Study - July 26th, 2020
- Seven Types of Drugs That Can Inhibit Sex Drive and Libido - July 22nd, 2020
- Testosterone and Geriatric Frailty - July 21st, 2020
- Testosterone and Aggression: How T-Levels Impact Human Response to External, Social Threats - July 12th, 2020
- High-Dose Testosterone Injections May Be a Viable Palliative Late-Stage Prostate Cancer Treatment - July 12th, 2020
- Could Civilization Have Been Formed as a Result of Declining Testosterone Levels in Males? - July 6th, 2020
- Testosterone Therapy Allows Man to Have the Body That He Was Meant to Have - July 5th, 2020
- Testosterone Injections for Low-T and Andropause - July 4th, 2020
- Testosterone Replacement Therapy (TRT) Reduces the Risk of Serious Adverse Health Consequences! - June 30th, 2020
- Testosterone not always to blame - Sat, 04 Aug 2012 PST - June 28th, 2020
- Five Facts About Testosterone (That Maybe You Didn't Know) - June 27th, 2020
- Manhood Washed Away: You Could Unknowingly be Annihilating Your Testosterone - June 23rd, 2020
- Testosterone: Should You Take it to Regain Your Libido and Youthful Energy? - June 22nd, 2020
- Testosterone Replacement Therapy Boosts Aerobic Capacity - June 15th, 2020
- Physiology of Testosterone - June 9th, 2020
- The Truth Behind Common Male Sex Myths - May 26th, 2020
- Dr. Andre Berger on Testosterone Deficiency in Men - Andropause Symptoms and Treatment By Doctor's Desk Series - May 21st, 2020
- How to Raise Testosterone Naturally. Sermorelin - Some Have Called It A The New Fountain of Youth. A Natural Cure for Anxiety and Depression. - May 9th, 2020
- Are Athletes Using Green Tea to Mask Testosterone Doping? - May 7th, 2020
- Some Animal Research Suggests that High Testosterone May Increase Prostate Cancer Risk - May 5th, 2020
Word Count: 521