Category Archives: Premature Ejaculation

(RTTNews.com) - Ampio Pharmaceuticals, Inc. (AMPE) announced the outcome of its pre-IND meeting with the CDER Urology and Reproductive group division of the U.S. Food and Drug Administration, or FDA, that took place on June 20, 2012. FDA gave all the necessary guidance on the design and conduct of two concurrent phase III pivotal clinical trials of around 15 weeks duration. Successful completion of these trials, powered adequately (based on the phase 3 European trials), will allow for FDA clearance to market Zertane as a treatment for life-long premature ejaculation, or PE. These clinical trials would qualify Zertane's registration/clearance under the 505(b) 2 regulatory pathway in the US, the company noted. Michael Macaluso, Ampio's chief executive officer, said, "We could not be more pleased, as the FDA guidance gave us a clear path to progress our Zertane drug through clinical development rapidly, with procedures that permit prompt resolution of the few outstanding issues, so we could commence the trials by the end of this year. This positive guidance will allow us to formalize our negotiations with potential partners. This productive meeting with the FDA was expected by the company because Zertane already successfully completed two phase II and two phase … Continue reading →

GREENWOOD VILLAGE, Colo., June 21, 2012 /PRNewswire/ -- Ampio Pharmaceuticals, Inc. (AMPE), a clinical stage biopharmaceutical company, with repurposed drugs and new molecular entities (NMEs) that treat inflammatory diseases, including osteoarthritis, diabetic macular edema (DME) and sexual dysfunction announced today the outcome of its pre-IND meeting with the CDER Urology and Reproductive group (DRUP) division of the FDA that took place on June 20, 2012. The FDA provided all the necessary guidance on the design and conduct of two concurrent phase III pivotal clinical trials of approximately 15 weeks duration. Successful completion of these trials, powered adequately (based on the phase 3 European trials), will allow for FDA clearance to market Zertane as a treatment for life-long premature ejaculation (PE) as defined by the International Society of Sexual Medicine. These clinical trials would qualify Zertane's registration/clearance under the 505(b) 2 regulatory pathway in the US. (Logo: http://photos.prnewswire.com/prnh/20120516/MM09116LOGO) Michael Macaluso, Ampio's CEO, noted, "We could not be more pleased, as the FDA guidance gave us a clear path to progress our Zertane drug through clinical development rapidly, with procedures that permit prompt resolution of the few outstanding issues, so we could commence the trials by the end of this year. This … Continue reading →

By Fiona Macrae and Roger Dobson PUBLISHED: 18:36 EST, 15 June 2012 | UPDATED: 18:55 EST, 15 June 2012 Pocket-sized solutions: The Tempe spray helps prevents premature ejaculation He put smiles on millions of faces when he helped invent Viagra. Now the brains behind the little blue pills claims to have done it again. Mike Wyllie, one of the team of scientists who developed Viagra in the 1990s, has created a drug that tackles premature ejaculation. He predicts the spray-on medication, designed to prolong the joy of sex for millions of sufferers and their partners, is likely to become the next blockbuster drug. Premature ejaculation affects more than one in four men making it more common than the impotence tackled by Viagra. Most are too embarrassed to seek help and when they do, treatments are generally limited to powerful anti-depressants and counselling. There is one pill specifically designed to treat the problem but it is expensive and not widely available in the UK. In contrast, it is hoped the spray, called Tempe, which could be on sale within months, will be cheap enough for prescription on the NHS. In trials, some men using the spray ahead of sex lasted up … Continue reading →

15 June 2012 Plethora Solutions Holdings PLC ("Plethora" or the "Company") Issue of Equity - Directors' Interest Plethora Solutions Holdings plc (AIM: PLE), the UK-based speciality pharmaceutical company, announces that it has made the following share issues. First (OTC BB: FSTC.OB - news) , 140,000 shares have been issued to the pension fund of Ronald Openshaw, CEO, Plethora Solutions (LSE: PLE.L - news) , at 5p per share to satisfy liabilities up to 31 May 2012. Following this issue Mr Openshaw has a beneficial interest in 416,669 shares representing approximately 0.2% of the enlarged issued share capital of the Company. The Company and Mr Openshaw have agreed that on an ongoing basis it will satisfy his pension contributions on a quarterly basis through the issue of new ordinary shares issued at the closing mid-market price on the day before issue. Further issues will be made as soon as practicable following the end of each calendar quarter. The next issue will be made following the end of the September quarter. This arrangement will remain in place for a minimum of 12 months and may be terminated, thereafter, by either party following not less 3 months notice and provided that the Company … Continue reading →

Happy and healthy ... solo sex helps you discover your body. 'Solo sex' is healthy and can enhance your relationships. So why are we still too embarrassed to talk about it, asks sex therapist Matty Silver. At dinner parties, people tend to talk about anything and everything, but you dont often hear conversations about masturbation or what I refer to as 'solo sex.' It is still a taboo topic that we are just too embarrassed to talk about. It is easy to explain why. Over the ages religious groups have condemned masturbation, claiming it inhibits self-control and promotes sexual promiscuity. Even today, the Dalai Lama does not approve of it and traditional Catholic, Orthodox Jewish and Muslim doctrine says masturbation constitutes a moral disorder. Just last week the Vatican condemned an American nun, Sister Margaret Farley, a professor emeritus of Christian ethics at Yale University, for her book Just Love: A Framework for Christian Sexual Ethics. On the subject of masturbation, she wrote that many women have found great good in self pleasuring, something many had not experienced or even known about in their ordinary sexual relations with husbands or lovers." Masturbation, she concludes, actually serves relationships rather then hindering … Continue reading →

14 June 2012 Plethora Solutions Holdings PLC ("Plethora" or the "Company") Subscription of Shares Plethora Solutions Holdings plc (AIM: PLE), the UK-based speciality pharmaceutical company, announces that it has issued 7,000,000 new ordinary shares of 1p each to raise 350,000 issued at a price of 5p per share on a non pre-emptive basis in accordance with the authorities granted at the last general meeting (the "Subscription"). As part of the Subscription, Galloway Limited, a company owned by a trust in which Mr Jim Mellon, a non-executive director of Plethora, has a life interest, will subscribe for 5,000,000 new shares and as a result his indirect beneficial interest will increase to 25,000,000 new shares, being approximately 12.0% of the enlarged capital of the Company. Application will be made for the new shares issued to be admitted to trading on AIM. ("Admission"). It is expected that Admission will be effective and trading will commence at 8:00am on 19 June 2012. Jim Mellon said: "As a director I am delighted to assist in providing funds to drive the business forward. Now that the company has submitted its full dossier for approval by the European Medicines Agency of its treatment for premature ejaculation the … Continue reading →

By Geoff Foster PUBLISHED: 16:47 EST, 11 June 2012 | UPDATED: 16:47 EST, 11 June 2012 Overweight bears had the life squeezed out of them after the Spanish government secured 80billion of funding for its ailing banking sector over the weekend. Share prices soared first thing on sheer relief but the euphoria did not last for long. Dealers soon questioned whether the bailout would be enough, while sceptics suggested it addresses the symptoms rather than the disease and only keeps the banking sector alive rather than supporting growth. Up 100 points before dealers had a chance to digest their cornflakes, the Footsie drifted steadily lower as shrewd fund managers trousered profits and the close was 2.71 points easier at 5,432.37. Share prices soared first thing on sheer relief but the euphoria did not last for long as dealers questioned whether the bailout would be enough The FTSE 250 traded 187 points up at best before ending 40.71 points down at 10,658.24. Wall Street opened almost 10 points lower. Neil Mackinnon, chief economist at VTB Capital, still advises extreme caution. He said: The eurozone debt and banking crisis remains unresolved and there is every chance that more bailouts will be needed … Continue reading →

GREENWOOD VILLAGE, Colo., June 11, 2012 /PRNewswire/ --Ampio Pharmaceuticals, Inc. (AMPE), a clinical stage biopharmaceutical company, whose lead drugs treat inflammatory diseases, including osteoarthritis and complications of Diabetes Mellitus such as diabetic macular edema (and others) announced today that it's CRO has completed analysis of the primary end point in the Optina clinical trial for DME conducted at St Michael Diabetes Hospital in Toronto Canada. (Logo: http://photos.prnewswire.com/prnh/20120516/MM09116LOGO) Dr. David Bar-Or, Ampio's Chief Science Officer (CSO), explained "The primary end point for efficacy was central subfield retinal thickness as measured by Optical Coherence Tomography (OCT) and reported in microns. The study was double masked and included 32 patients with moderate to severe diabetic macular edema (range 316-707microns) that were treated orally with either placebo or one of three doses of Optina. Central retinal thickness and retinal volumes were measured at baseline and at 4 and 12 weeks of treatment. The results confirm a significant interaction between the patient's body mass index (BMI) and efficacy at the different doses of Optina. For higher BMI (BMI=35) patients, higher doses of Optina were more effective and for lower BMI (BMI=26) patients, lower doses were more effective. The improvement of efficacy by adjusting the dose … Continue reading →

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 … Continue reading →

CHARLOTTE, N.C. -- Joey Logano was on a bar stool in the Daytona 500 Club before a January test session, but he might as well have been on a witness stand in a courtroom the way he was being pounded with questions about how this is a make-or-break season, how if he doesn't make the Chase, his future with Joe Gibbs Racing is in jeopardy. "Obviously, this is a contract year," Logano responded calmly. "Obviously, I see where you're coming from. [I] better pick it up. I understand that. I see that." Judging by the weekly questions on ESPN.com chats, the daily emails and comments on Twitter, many don't believe Logano has done that. Many believe he's got a foot out the door even though team owner Joe Gibbs has shown nothing but confidence in his 22-year-old driver in only his fourth year in the Sprint Cup Series. John David Mercer/US PresswireJoey Logano sits 16th in the Cup standings, but he's got four wins this season in the Nationwide Series. Some have speculated that Kurt Busch already has been penciled in as the next driver for the No. 20 Home Depot car. Well, they did before Busch's meltdown with yet … Continue reading →