11 June 2012
Plethora Solutions Holdings PLC
("Plethora" or the "Company")
PSD502 Regulatory Submission Update
Plethora announces that it has submitted a dossier to the European Medicines Agency ("EMA") for the approval of PSD502 as a new medicine to treat premature ejaculation ("PE"). The Company is seeking approval of PSD502 through the centralised procedure, which if and when granted would provide the ability to sell the product across all 27 member states. Based on normal timelines the Company anticipates that approval should occur 12-18 months following submission.
PSD502 is a topical spray containing two local anaesthetics, prilocaine and lidocaine. The product completed two phase III pivotal trials in 2009 and has been tested on over 600 patients with a total of approximately 26,000 doses delivered. The Company believes that the clinical studies conducted to date demonstrate that PSD502 is safe and highly effective in treating PE.
The International Society of Sexual Medicine ("ISSM") defined PE as a male sexual dysfunction characterised by: ejaculation that always or nearly always occurs prior to or within about one minute of vaginal penetration; the inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences such as distress, bother, frustration and/or the avoidance of sexual intimacy.
The incidence of PE has been studied and reported in peer reviewed academic journals on multiple occasions. While estimates vary, PE is reported to affect approximately 20-30% of sexually active men. Data shows that the incidence of PE is consistent across all age, socio-economic, geographic and ethnic groups. The Company estimates that the incidence of PE in the general population is potentially larger than the incidence of erectile dysfunction.
In the 27 member states of the European Union, the Company estimates that there are in excess of 150 million men aged between 20-69 years old. With the estimated incidence of PE this implies that the potential population of men in the EU with the disorder is approximately 30-45 million. A centralised approval of PSD502 by the EMA would permit the product to be marketed to this entire group.
As with erectile dysfunction 15 years ago before the introduction of Pfizer (BSE: PFIZERSL.BO - news) 's Viagra, premature ejaculation is not widely treated. The Company believes this is because of an absence of a generally available safe, effective and approved pharmaceutical treatment. The Company believes there is a significant unmet medical need in the treatment of PE. At present only one product, Priligy, is approved, in only a limited number of countries. In a post launch study it was shown that up to 90% of patients discontinued use of this product. This was due to a lack of clinical effect, restrictive side effects and/or cost.
See the rest here:
Plethora Solutions - PSD502 Regulatory Submission Update
- Last Longer In Bed With Subliminal Hypnosis - Cure Premature Ejaculation - Video [Last Updated On: April 8th, 2012] [Originally Added On: April 8th, 2012]
- PREMATURE EJACULATION - Video [Last Updated On: April 8th, 2012] [Originally Added On: April 8th, 2012]
- Cure premature ejaculation -Learn how to control premature ejaculation - Video [Last Updated On: April 8th, 2012] [Originally Added On: April 8th, 2012]
- Premature ejaculation: an office problem - Video [Last Updated On: April 8th, 2012] [Originally Added On: April 8th, 2012]
- How to Control Your Premature Ejaculation - PROMESCENT speaks with Felice Dunas - Video [Last Updated On: April 8th, 2012] [Originally Added On: April 8th, 2012]
- How Do I Know If I Have Premature Ejaculation? - Video [Last Updated On: April 8th, 2012] [Originally Added On: April 8th, 2012]
- Zoloft For Premature Ejaculation - Does It Work? - Video [Last Updated On: April 8th, 2012] [Originally Added On: April 8th, 2012]
- Does Hypnosis For Premature Ejaculation Work? - Video [Last Updated On: April 8th, 2012] [Originally Added On: April 8th, 2012]
- Can Viagra Treat Premature Ejaculation? - Video [Last Updated On: April 8th, 2012] [Originally Added On: April 8th, 2012]
- Supplements For Premature Ejaculation - Do They Work? - Video [Last Updated On: April 8th, 2012] [Originally Added On: April 8th, 2012]
- Talk to DaveyJCole #11 : Older Girls, Premature Ejaculation, Weight Loss, Numbers [Last Updated On: April 8th, 2012] [Originally Added On: April 8th, 2012]
- In the Bedroom with Dr. Laura Berman - Premature Ejaculation - Oprah Winfrey Network - Video [Last Updated On: April 8th, 2012] [Originally Added On: April 8th, 2012]
- Pelvic Floor Exercise For Your Premature Ejaculation Problem - Video [Last Updated On: April 8th, 2012] [Originally Added On: April 8th, 2012]
- Classic Col Elliott On Premature Ejaculation - Video [Last Updated On: April 8th, 2012] [Originally Added On: April 8th, 2012]
- Premature Ejaculation Cure Using Pelvic Floor Exercises - Video [Last Updated On: April 8th, 2012] [Originally Added On: April 8th, 2012]
- Premature Ejaculation Cures + Jodie Foster + Late Show with David Letterman - Video [Last Updated On: April 8th, 2012] [Originally Added On: April 8th, 2012]
- How To Avoid Premature Ejaculation - 4 Practical Delaying Tips - Video [Last Updated On: April 8th, 2012] [Originally Added On: April 8th, 2012]
- Premature Ejaculation Cures + Blake Lively + Late Show with David Letterman - Video [Last Updated On: April 8th, 2012] [Originally Added On: April 8th, 2012]
- Premature Ejaculation Cures + Lisa Kelly + Late Show with David Letterman - Video [Last Updated On: April 8th, 2012] [Originally Added On: April 8th, 2012]
- Premature Ejaculation Cures + Seth Meyers + SNL + Late Show with David Letterman - Video [Last Updated On: April 8th, 2012] [Originally Added On: April 8th, 2012]
- Stendra (Avanafil) For Erectile Dysfunction Approved By FDA [Last Updated On: April 29th, 2012] [Originally Added On: April 29th, 2012]
- Research and Markets: Case Studies in Abnormal Psychology, 9th Edition Includes a Number of Transcripts of Therapy ... [Last Updated On: May 4th, 2012] [Originally Added On: May 4th, 2012]
- Furiex Pharmaceuticals Announces Agreement to Transfer Priligy® Product Rights [Last Updated On: May 15th, 2012] [Originally Added On: May 15th, 2012]
- Furiex Pharmaceuticals and Menarini Announce License Agreement for Priligy® [Last Updated On: May 15th, 2012] [Originally Added On: May 15th, 2012]
- Furiex Enters Agreement For Priligy Product Rights [Last Updated On: May 15th, 2012] [Originally Added On: May 15th, 2012]
- Hideous suit, rictus grin, silver strands... has former French first lady Carla Bruni-Sarkozy come to this? [Last Updated On: May 18th, 2012] [Originally Added On: May 18th, 2012]
- Making a connection [Last Updated On: May 27th, 2012] [Originally Added On: May 27th, 2012]
- The 7 Greatest Viral Andy Samberg Videos [Last Updated On: June 6th, 2012] [Originally Added On: June 6th, 2012]
- Newton: 'Sliced Bread' getting a little stale? [Last Updated On: June 8th, 2012] [Originally Added On: June 8th, 2012]
- Ampio Announces Positive Clinical Trial Results for the Treatment of Diabetic Macular Edema with Orally Administered ... [Last Updated On: June 11th, 2012] [Originally Added On: June 11th, 2012]
- MARKET REPORT: Bears battered by euro rescue [Last Updated On: June 12th, 2012] [Originally Added On: June 12th, 2012]
- Plethora Solutions - Subscription of Shares [Last Updated On: June 14th, 2012] [Originally Added On: June 14th, 2012]
- Why is masturbation such a taboo topic? [Last Updated On: June 15th, 2012] [Originally Added On: June 15th, 2012]
- Plethora Solutions - Issue of Equity - Directors' Interest [Last Updated On: June 15th, 2012] [Originally Added On: June 15th, 2012]
- From an inventor of Viagra, a spray to help love last beyond a moment [Last Updated On: June 16th, 2012] [Originally Added On: June 16th, 2012]
- Ampio Reports Successful Type B Pre-IND Meeting with the FDA for its Drug Zertane™ to treat Premature Ejaculation (PE) [Last Updated On: June 22nd, 2012] [Originally Added On: June 22nd, 2012]
- Ampio Reports Successful Type B Pre-IND Meeting With FDA For Zertane To Treat PE [Last Updated On: June 22nd, 2012] [Originally Added On: June 22nd, 2012]
- Ampio signs deal with Biocon unit on sexual dysfunction drug [Last Updated On: July 2nd, 2012] [Originally Added On: July 2nd, 2012]
- Ampio Contracts with Syngene to Manufacture Zertane-ED™, its Recently Patented Combination Drug to Treat both ... [Last Updated On: July 2nd, 2012] [Originally Added On: July 2nd, 2012]
- Ampio Contracts with Syngene to Manufacture Zertane-ED(TM), its Recently Patented Combination Drug to Treat both ... [Last Updated On: July 2nd, 2012] [Originally Added On: July 2nd, 2012]
- Equity Briefing : Ampio Pharmaceuticals, Amylin Pharmaceuticals and Cytori Therapeutics moving higher [Last Updated On: July 2nd, 2012] [Originally Added On: July 2nd, 2012]
- Promescent® Featured in World Meeting on Sexual Medicine 2012 [Last Updated On: August 3rd, 2012] [Originally Added On: August 3rd, 2012]
- Revolutionary Device for Premature Ejaculation Treatment [Last Updated On: September 6th, 2012] [Originally Added On: September 6th, 2012]
- “No, honey, it really is OK” [Last Updated On: September 19th, 2012] [Originally Added On: September 19th, 2012]
- Research and Markets: Premature Ejaculation - Pipeline Review, H2 2012 [Last Updated On: September 30th, 2012] [Originally Added On: September 30th, 2012]
- Liu Xiang furious after being featured in premature ejaculation ad [Last Updated On: September 30th, 2012] [Originally Added On: September 30th, 2012]
- Chinese sports ads are the best sports ads [Last Updated On: September 30th, 2012] [Originally Added On: September 30th, 2012]
- Gross and Embarrassing [Last Updated On: October 5th, 2012] [Originally Added On: October 5th, 2012]
- Dan Savage: “It was going to be a joke” [Last Updated On: October 7th, 2012] [Originally Added On: October 7th, 2012]
- CAPScall of the Week: Ampio Pharmaceuticals [Last Updated On: October 10th, 2012] [Originally Added On: October 10th, 2012]
- Rizer XL Rated #1 Male Enhancement Pill by Total Penis Health [Last Updated On: October 13th, 2012] [Originally Added On: October 13th, 2012]
- Ejaculation Trainer | How To Prevent Premature Ejaculation Permanently – Health Review Center [Last Updated On: October 16th, 2012] [Originally Added On: October 16th, 2012]
- Tackling the Unspoken Taboo – Hypnotherapy Directory Reveals the Secret to Banishing Sexual Issues from the Bedroom [Last Updated On: October 16th, 2012] [Originally Added On: October 16th, 2012]
- Plethora's PSD502 drug has mass market potential [Last Updated On: October 17th, 2012] [Originally Added On: October 17th, 2012]
- Priligy premature ejaculation [Last Updated On: November 1st, 2012] [Originally Added On: November 1st, 2012]
- Last Longer In Bed [Last Updated On: November 1st, 2012] [Originally Added On: November 1st, 2012]
- Girls of Prague - clip 14 - Video [Last Updated On: November 1st, 2012] [Originally Added On: November 1st, 2012]
- Girls of Prague - clip 12 - Video [Last Updated On: November 1st, 2012] [Originally Added On: November 1st, 2012]
- Girls of Prague - clip 10 - Video [Last Updated On: November 1st, 2012] [Originally Added On: November 1st, 2012]
- Girls of Prague - clip 8 - Video [Last Updated On: November 1st, 2012] [Originally Added On: November 1st, 2012]
- Girls of Prague - clip 7 - Video [Last Updated On: November 1st, 2012] [Originally Added On: November 1st, 2012]
- Girls of Prague - clip 6 - Video [Last Updated On: November 1st, 2012] [Originally Added On: November 1st, 2012]
- Girls of Prague - clip 4 - Video [Last Updated On: November 1st, 2012] [Originally Added On: November 1st, 2012]
- Girls of Prague - clip 3 - Video [Last Updated On: November 1st, 2012] [Originally Added On: November 1st, 2012]
- Girls of Prague - clip 2 - Video [Last Updated On: November 1st, 2012] [Originally Added On: November 1st, 2012]
- Girls of Prague - clip 17 - Video [Last Updated On: November 1st, 2012] [Originally Added On: November 1st, 2012]
- Girls of Prague - clip 11 - Video [Last Updated On: November 1st, 2012] [Originally Added On: November 1st, 2012]
- Girls of Prague - clip 5 - Video [Last Updated On: November 1st, 2012] [Originally Added On: November 1st, 2012]
- Girls of Prague - clip 1 - Video [Last Updated On: November 1st, 2012] [Originally Added On: November 1st, 2012]
- Cure Hemorrhoids Fast - Video [Last Updated On: November 1st, 2012] [Originally Added On: November 1st, 2012]
- How To Get Premature Ejaculation Help - Video [Last Updated On: November 1st, 2012] [Originally Added On: November 1st, 2012]
- Advanced Male Medical Center Raises Awareness for Atherosclerosis [Last Updated On: November 3rd, 2012] [Originally Added On: November 3rd, 2012]
- Shilajit Capsule / premature ejaculation nocturnal Shilajit Capsule For Men Sexual Health Wellbegin - Video [Last Updated On: November 3rd, 2012] [Originally Added On: November 3rd, 2012]
- Trance for premature ejaculation - Video [Last Updated On: November 3rd, 2012] [Originally Added On: November 3rd, 2012]
- Killpocalypse! - Video [Last Updated On: November 3rd, 2012] [Originally Added On: November 3rd, 2012]
- Prevent Premature Ejaculation -Tips For Learning How to Prevent Premature Ejaculation - Video [Last Updated On: November 3rd, 2012] [Originally Added On: November 3rd, 2012]
- how to stop premature ejaculating - learn more here - Video [Last Updated On: November 3rd, 2012] [Originally Added On: November 3rd, 2012]
- premature ejaculation - learn more here - Video [Last Updated On: November 3rd, 2012] [Originally Added On: November 3rd, 2012]
- What exactly is premature ejaculation? Special Presentation Ejaculation By Command - Video [Last Updated On: November 3rd, 2012] [Originally Added On: November 3rd, 2012]
- How I Cured My Premature Ejaculation Using Ejaculation Ejaculation by Command - Video [Last Updated On: November 3rd, 2012] [Originally Added On: November 3rd, 2012]