Dapoxetine 2190486 225552756 2008-07-14T07:50:20Z Rjwilmsi 203434 no 'of' between a month and a year per [[Wikipedia:Manual_of_Style_%28dates_and_numbers%29#Longer_periods|MOS]] using [[Project:AutoWikiBrowser|AWB]] {{drugbox | | IUPAC_name = (1S)-N,N-dimethyl-3-naphthalen-1-yloxy-1-phenyl</br>-propan-1-amine | image = Dapoxetine-2D-skeletal.png | CAS_number = 119356-77-3 | CAS_supplemental = 129938-20-1 (HCl salt) | ATC_prefix = | ATC_suffix = | PubChem = 71353 | DrugBank = | chemical_formula = | molecular_weight = 305.413 g/mol | bioavailability = | protein_bound = | metabolism = | elimination_half-life = | excretion = | pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> | pregnancy_US = <!-- A / B / C / D / X --> | pregnancy_category= | legal_AU = <!-- Unscheduled / S2 / S3 / S4 / S5 / S6 / S7 / S8 / S9 --> | legal_CA = <!-- / Schedule I, II, III, IV, V, VI, VII, VIII --> | legal_UK = <!-- GSL / P / POM / CD / Class A, B, C --> | legal_US = <!-- OTC / Rx-only / Schedule I, II, III, IV, V --> | legal_status = Rx-only | routes_of_administration = Oral }} '''Dapoxetine''' is the [[International Nonproprietary Name]] of a short-acting [[Selective serotonin reuptake inhibitor|SSRI]] drug<ref name="pmid18360636">{{cite journal |author=Kendirci M, Salem E, Hellstrom WJ |title=Dapoxetine, a novel selective serotonin transport inhibitor for the treatment of premature ejaculation |journal=Ther Clin Risk Manag |volume=3 |issue=2 |pages=277–89 |year=2007 |month=June |pmid=18360636 |doi= |url=}}</ref> currently being considered for approval by the [[Food and Drug Administration]] (FDA) for the treatment of [[premature ejaculation]] in men, which would make it the first drug approved for such treatment. It is currently in Phase III of the approval process. ==Function== If approved, this would make Dapoxetine join the ranks of [[erectile dysfunction]] drugs such as [[sildenafil]] (Viagra), [[tadalafil]] (Cialis), and [[vardenafil]] (Levitra), and some dopamine agonists such as [[cabergoline]] (Dostinex) and [[pramipexole]], as drugs which can be used to improve male [[sexual health]]. Misuse of these drugs as [[aphrodisiacs]] or sexual enhancers in individuals who do not suffer from sexual health problems is also a possibility and there have been some concerns about doctors being pressured to prescribe such drugs off-label to people who do not actually have a medical need for the drug. Some research has shown Dapoxetine to have a benefit in the treatment of premature ejaculation.<ref name="pmid17625501">{{cite journal |author=Safarinejad MR |title=Safety and Efficacy of Dapoxetine in the Treatment of Premature Ejaculation: A Double-Blind, Placebo-Controlled, Fixed-Dose, Randomized Study |journal= Neuropsychopharmacology|volume= 33|issue= |pages= 1259|year=2007 |pmid=17625501 |doi=10.1038/sj.npp.1301500}}</ref> ==Approval process== Dapoxetine was created by [[Eli Lilly and Company]] and is credited to biochemist David T. Wong. Originally known as LY 210448, it was being developed by Lilly as an antidepressant. Eli Lilly sold the patent to [[Johnson & Johnson]] for $65 million dollars and future royalties in December 2003. Dapoxetine was submitted to the FDA in the form of dapoxetine hydrochloride by the [[ALZA Corporation]] and its parent company, Johnson & Johnson for the treatment of premature ejaculation with a New Drug Application (NDA) to the Food and Drug Administration (FDA) on December 28, 2004. In October 2005, the FDA issued a "not approvable" letter for dapoxetine.<ref>http://www.jnj.com/news/jnj_news/20051026_164127.htm</ref> Despite two clinical trials finished in 2006, experts doubt it will be approved by the FDA soon because SSRIs come with undesirable side-effects after long-term use, such as psychiatric problems, dermatological reactions, increase in body weight, lower sex-drive, nausea, headache, upset stomach and weakness, thus not significantly outweighing the benefit of premature ejaculation medication versus the risks. Dapoxetine was submitted for approval in Europe and is now being reviewed. ==References== {{reflist}} ==External links== * [http://pehomepage.com/Treating-PE/Medications/Treatment_for_premature_ejaculation_Interview_with_Lead_Investigator_for_Dapoxetine_(_Priligy_™_)_77.html "PEhomepage.com - treatments for premature ejaculation"] - an article on dapoxetine * [http://www.webmd.com/content/article/127/116615.htm "Premature Ejaculation Drug Promising"] * [http://www.msnbc.msn.com/id/8478505/ "The many mysteries of the female orgasm"] - An editorial about advances in sexual pharmacology [[Category:Urology]] {{pharma-stub}} [[fr:Dapoxétine]]