Dapoxetine: Difference between revisions

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{{drugbox |
{{drugbox |
| IUPAC_name        = (1S)-N,N-dimethyl-3-naphthalen-1-yloxy-1-phenyl</br>-propan-1-amine
| IUPAC_name        = (1S)-N,N-dimethyl-3-naphthalen-1-yloxy-1-phenyl</br>-propan-1-amine
| image            = Dapoxetine-2D-skeletal.png
| image            =
| CAS_number        = 119356-77-3   
| CAS_number        = 119356-77-3   
| CAS_supplemental  = 129938-20-1 (HCl salt)
| CAS_supplemental  = 129938-20-1 (HCl salt)
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==Overview==
==Overview==
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==Function==
==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.  
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= |volume= |issue= |pages= |year=2007 |pmid=17625501 |doi=10.1038/sj.npp.1301500}}</ref>
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= |volume= |issue= |pages= |year=2007 |pmid=17625501 |doi=10.1038/sj.npp.1301500}}</ref>
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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 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.
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 of 2005, the FDA issued a "not approvable" letter for dapoxetine.<ref>http://www.jnj.com/news/jnj_news/20051026_164127.htm</ref>
In October of 2005, the FDA issued a "not approvable" letter for dapoxetine.<ref>http://www.jnj.com/news/jnj_news/20051026_164127.htm</ref>
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* [http://www.webmd.com/content/article/127/116615.htm "Premature Ejaculation Drug Promising"]
* [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
* [http://www.msnbc.msn.com/id/8478505/ "The many mysteries of the female orgasm"] - An editorial about advances in sexual pharmacology


[[Category:Urology]]
[[Category:Urology]]
[[Category:Pharmacology]]
[[Category:Pharmacology]]


[[fr:Dapoxétine]]
[[fr:Dapoxétine]]


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Latest revision as of 00:29, 9 August 2012

Dapoxetine
Clinical data
Routes of
administration		Oral
Legal status
Legal status
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
PubChem CID
E number{{#property:P628}}
ECHA InfoCard{{#property:P2566}}Lua error in Module:EditAtWikidata at line 36: attempt to index field 'wikibase' (a nil value).
Chemical and physical data
Molar mass305.413 g/mol

Template:Search infobox Steven C. Campbell, M.D., Ph.D.


Overview

Dapoxetine is the International Nonproprietary Name of a short-acting SSRI drug 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.[1]

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 of 2005, the FDA issued a "not approvable" letter for dapoxetine.[2]

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.

References

  1. ↑ Safarinejad MR (2007). "Safety and Efficacy of Dapoxetine in the Treatment of Premature Ejaculation: A Double-Blind, Placebo-Controlled, Fixed-Dose, Randomized Study". doi:10.1038/sj.npp.1301500. PMID 17625501.
  2. ↑ http://www.jnj.com/news/jnj_news/20051026_164127.htm

External links


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