PDE5 inhibitors

FDA Grants Meeting to Petros Pharmaceuticals to Discuss Label Expansion of Erectile Dysfunction Drug STENDRA®

Retrieved on: 
Tuesday, July 27, 2021
Chemical compounds, PDE5 inhibitors, Organic compounds, Chemistry, cGMP-specific phosphodiesterase type 5, Avanafil, Phosphodiesterase, Erectile dysfunction, Sildenafil, Phosphodiesterase inhibitor

"While the PDE5 inhibitor class of erectile dysfunction drugs has a respected history, we believe that the data collected on STENDRA may further differentiate it from other drugs in the class.

Key Points: 
  • "While the PDE5 inhibitor class of erectile dysfunction drugs has a respected history, we believe that the data collected on STENDRA may further differentiate it from other drugs in the class.
  • We look forward to sharing our data with the FDA and discussing the additional necessary steps toward modification of the STENDRA label, and thereby the patient populations that may benefit from treating their erectile dysfunction with STENDRA."
  • Stendra(avanafil), originally launched by Auxilium Pharmaceuticals prior to that company's sale to Endo Pharmaceuticals, is an oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of erectile dysfunction.
  • STENDRA may affect the way other medicines work, and other medicines may affect the way STENDRA works, which may cause side effects.

Eight arrests for selling potentially dangerous food supplements online

Retrieved on: 
Wednesday, May 12, 2021
Chemical compounds, PDE5 inhibitors, Lactams, Organic compounds, Heterocyclic compounds, Piperazines, Pyrazolopyrimidines, Sildenafil, Dietary supplement, Tadalafil, Ingredient, Erectile dysfunction

In 2019, NAS Carabinieri detected some food supplements, allegedly made of natural ingredients, which actually contained the pharmaceutical ingredients sildenafil and tadalafil.

Key Points: 
  • In 2019, NAS Carabinieri detected some food supplements, allegedly made of natural ingredients, which actually contained the pharmaceutical ingredients sildenafil and tadalafil.
  • The product, recommended for the treatment of erectile dysfunction, was sold on a well-known e-commerce platform.
  • The results of analysis carried out on samples from test purchases of the product confirmed the presence of these active ingredients.
  • Food supplements illegally containing a medical active ingredient could be sold in a deceptive way to consumers, generating high risks for public health.

Advisory - Male sexual enhancement product "Harmony" may pose serious health risks

Retrieved on: 
Friday, March 5, 2021
PDE5 inhibitors, Lactams, Chemical compounds, Penis, Organic compounds, Psychiatric diagnosis, Diketopiperazines, Tadalafil, Erectile dysfunction, Sildenafil

Issue:The product contains high levels of a prescription erectile dysfunction drug, tadalafil, which may pose serious health risks.

Key Points: 
  • Issue:The product contains high levels of a prescription erectile dysfunction drug, tadalafil, which may pose serious health risks.
  • Health Canada is warning consumers to not use Harmony, a male sexual enhancement capsule, because it may pose serious health risks.
  • It was authorized as a natural health product, but Health Canada testing found it contains high levels of a prescription erectile dysfunction drug, tadalafil.
  • The product was not authorized to contain tadalafil, it was not authorized as a sexual enhancement product, and it did not list tadalafil on the product label.

Global Erectile Dysfunction Drugs Markets, 2020-2030: Sildenafil Citrate, Mirodenafil, Vardenafil, Tadalafil, Udenafil, Stendra/ Spedra, & Lodenafil Carbonate

Retrieved on: 
Wednesday, February 17, 2021
Medical specialties, Lactams, PDE5 inhibitors, Sexual arousal, Sexual health, Urology

The erectile dysfunction (ED) drugs market consists of sales of erectile dysfunction (ED) drugs and related services.

Key Points: 
  • The erectile dysfunction (ED) drugs market consists of sales of erectile dysfunction (ED) drugs and related services.
  • The erectile dysfunction drugs market has been geographically segmented into North America, Western Europe, APAC, Eastern Europe, South America and Middle East & Africa.
  • Prevalence of chronic diseases increases the chances of erectile dysfunction among men, thereby driving the erectile dysfunction drugs market.
  • Global Drugs For Erectile Dysfunction Market, Segmentation By Drugs, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

Erectile Dysfunction Market Size to Reach Revenues of USD 4.7 Billion by 2026 - Arizton

Retrieved on: 
Tuesday, February 9, 2021
Medical specialties, Chemical compounds, Lactams, PDE5 inhibitors, Men's Health, Penis, Penile erection, Piperazines, Sildenafil, Erectile dysfunction, Penile implant, Tadalafil

Oral therapies, especially Viagra, Cialis, and Levitra, dominated the market with around USD 3.8 billion revenue in 2020.

Key Points: 
  • Oral therapies, especially Viagra, Cialis, and Levitra, dominated the market with around USD 3.8 billion revenue in 2020.
  • The penile implants segment accounted for the largest share of around 49% in 2020 in the global ED devices market.
  • Vacuum constriction devices (VCD) accounted for over 39% of the global erectile dysfunction devices market in 2020.
  • Over 90% of the patient population experienced successful erectile function with VCD, thereby boosting the market growth.

Erectile Dysfunction Market Size to Reach Revenues of USD 4.7 Billion by 2026 - Arizton

Retrieved on: 
Tuesday, February 9, 2021
Medical specialties, Chemical compounds, Lactams, PDE5 inhibitors, Men's Health, Penis, Penile erection, Piperazines, Sildenafil, Erectile dysfunction, Penile implant, Tadalafil

Oral therapies, especially Viagra, Cialis, and Levitra, dominated the market with around USD 3.8 billion revenue in 2020.

Key Points: 
  • Oral therapies, especially Viagra, Cialis, and Levitra, dominated the market with around USD 3.8 billion revenue in 2020.
  • The penile implants segment accounted for the largest share of around 49% in 2020 in the global ED devices market.
  • Vacuum constriction devices (VCD) accounted for over 39% of the global erectile dysfunction devices market in 2020.
  • Over 90% of the patient population experienced successful erectile function with VCD, thereby boosting the market growth.

Advisory - Multiple unauthorized health products seized from stores in Ontario, Québec and Alberta because they may pose serious health risks

Retrieved on: 
Wednesday, October 21, 2020
Chemical compounds, Organic compounds, Steroids, RTT, PDE5 inhibitors, Androstanes, Lactams, Enones, Tadalafil, Sildenafil, Testosterone, Erectile dysfunction

Product was previously tested by Health Canada and found to contain sildenafil and tadalafil.

Key Points: 

Product was previously tested by Health Canada and found to contain sildenafil and tadalafil.
Product was tested by Health Canada and found to contain sildenafil, tadalafil and testosterone propionate

Aspargo Laboratories, Inc. Acquires International Rights to Sildenafil Oral Spray for the Treatment of Erectile Dysfunction

Retrieved on: 
Tuesday, September 29, 2020
PDE5 inhibitors, Chemical compounds, Organic compounds, Lactams, Piperazines, Penis, RTT, Pyrazolopyrimidines, Sildenafil, Erectile dysfunction, Medication, Herbal viagra

Aspargo acquired the exclusive U.S. patent rights covering Sildenafil Oral Spray from Farmalider, S.A. in January 2020.

Key Points: 
  • Aspargo acquired the exclusive U.S. patent rights covering Sildenafil Oral Spray from Farmalider, S.A. in January 2020.
  • In May 2020, Aspargo announced the results of its pre-Investigational New Drug (pre-IND) meeting with the United States Food & Drug Administration (FDA), where the FDA addressed Aspargo's questions and provided guidance on the Companys Sildenafil Oral Spray for the treatment of erectile dysfunction (ED).
  • Aspargos oral spray suspension formulation of sildenafilcitrate (Sildenafil Oral Spray), the active ingredient in VIAGRA, is a novel and convenient route of administration for this commonly prescribed medication for erectile dysfunction.
  • Aspargo is the US and international licensee of the patent rights covering Sildenafil Oral Spray from Farmalider, S.A. of Madrid, Spain (www.farmalider.com).

Lover App's Online Erection Confidence Course as Effective as Medication for Treating Erectile Dysfunction

Retrieved on: 
Thursday, July 16, 2020
Men's Health, Penis, Chemical compounds, Medical specialties, RTT, Lactams, PDE5 inhibitors, Penile erection, Sildenafil, Erectile dysfunction, Erection, Ro

SAN FRANCISCO, July 16, 2020 /PRNewswire/ -- Today, leading sexual wellness app Lover, announced the promising results of its "Erection Confidence Course" released in the beta version of the app.

Key Points: 
  • SAN FRANCISCO, July 16, 2020 /PRNewswire/ -- Today, leading sexual wellness app Lover, announced the promising results of its "Erection Confidence Course" released in the beta version of the app.
  • These results are proportionate with studies* showing 66% of men reported improvements from taking Sildenafil citrate, the active ingredient in the best-known erectile dysfunction medication, Viagra.
  • According to various studies**, over 50% of men over 50, and 1 in 4 men under 40, suffer from Erectile Dysfunction (ED) of some form.
  • The results of this program suggest that this may be the first digital, pill-free solution to ED that actually works.

Aspargo Laboratories, Inc. Announces Successful Completion of Pre-IND Meeting with FDA on Sildenafil Oral Spray for the Treatment of Erectile Dysfunction

Retrieved on: 
Monday, May 4, 2020
Chemical compounds, PDE5 inhibitors, Lactams, RTT, Piperazines, Organic compounds, Penis, Pyrazolopyrimidines, Sildenafil, Erectile dysfunction, Bioequivalence, Herbal viagra

The FDA was supportive of a single dose bioequivalent study comparing Aspargos Sildenafil Oral Spray, an oral liquid suspension formulation of sildenafil citrate, with Viagra tablets and deemed the 505(b)(2) regulatory pathway appropriate for the program.

Key Points: 
  • The FDA was supportive of a single dose bioequivalent study comparing Aspargos Sildenafil Oral Spray, an oral liquid suspension formulation of sildenafil citrate, with Viagra tablets and deemed the 505(b)(2) regulatory pathway appropriate for the program.
  • We look forward to advancing Sildenafil Oral Spray in the U.S. market to provide men who suffer from erectile dysfunction a differentiated dosing formulationthat provides convenient administration, flexible dosing and access for ED patients who have difficulty swallowing oral tablets.
  • Aspargo is the exclusive U.S. licensee of the U.S. patent rights covering Sildenafil Oral Spray from Farmalider, S.A. of Madrid, Spain ( www.farmalider.com ).
  • Except as required by law, Aspargo disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.