Dapoxetine
From Wikipedia, the free encyclopedia
 |
|
|
Dapoxetine
|
|
| Systematic (IUPAC) name | |
| (S)-N,N-dimethyl-3-(naphthalen-1-yloxy)-1-phenylpropan-1-amine | |
| Identifiers | |
| CAS number | 129938-20-1 (HCl salt) |
| ATC code | none |
| PubChem | |
| Chemical data | |
| Formula | C21H23NO |
| Mol. mass | 305.413 g/mol |
| Pharmacokinetic data | |
| Bioavailability | ? |
| Metabolism | ? |
| Half life | ? |
| Excretion | ? |
| Therapeutic considerations | |
| Pregnancy cat. |
? |
| Legal status |
℞ Prescription only |
| Routes | Oral |
Dapoxetine (INN, brand name Priligy) is a short-acting SSRI drug[1] for the treatment of premature ejaculation in men. Dapoxetine is the only drug with regulatory approval for such treatment. Currently, it is approved for use in several European countries including Finland, Sweden, Portugal, Austria and Germany.[2][3][4] Dapoxetine is also being considered for approval in other European countries and in the United States where it is currently in Phase III of the Food and Drug Administration (FDA) approval process.[5]
Contents |
[edit] Function
Research has shown dapoxetine to have a benefit in the treatment of premature ejaculation.[6] In a report published in the 'British Journal of Urology' based on data from the phase III trial, authors conclude that dapoxetine is well tolerated and found to improve all variables associated with premature ejaculation, including reduction of personal distress, interpersonal difficulty and improvement in the satisfaction with the sexual intercourse.[7]
Dapoxetine joins 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 that 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.[citation needed]
[edit] Diagnosis of PE
[edit] Premature Ejaculation Diagnostic Tool
Pfizer Inc, together with leading Premature Ejaculation experts, have developed a diagnostic tool to help physicians and patients diagnose this condition. The methodology and results were published several times in medical congresses and peer reviewed medical journals .[8][9]. The three different categories a patient can be classified to are: No PE; Probable PE; and PE.
[edit] 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.
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).
In October 2005, the FDA issued a "not approvable" letter for dapoxetine, delaying approval in the United States.[10]
Despite two further clinical trials completed in 2006, it has yet to be approved by the FDA.
Dapoxetine was submitted for approval in Europe and is now being reviewed.
In Feb 2009, it has first received approval in Sweden & Finland. Later, in Austria, Portugal and recently in Germany, Italy and Spain. Approvals for dapoxetine are also anticipated in other European countries as well. Filings for approval have been submitted in Canada, Australia, Mexico, Turkey and six other countries.[5]
[edit] References
- ^ Kendirci M, Salem E, Hellstrom WJ (June 2007). "Dapoxetine, a novel selective serotonin transport inhibitor for the treatment of premature ejaculation". Ther Clin Risk Manag 3 (2): 277–89. doi:. PMID 18360636.
- ^ Johnson & Johnson Reports 2009 First-Quarter Results
- ^ PPD Reports First Quarter 2009 Financial Results
- ^ PRILIGY (Dapoxetin) erhält die Zulassung für die Behandlung der Ejaculatio praecox in Deutschland
- ^ a b Janssen-Cilag EMEA announces receipt of first regulatory approvals for Priligy for PE in Finland and Sweden, February 11, 2009
- ^ Safarinejad MR (2007). "Safety and Efficacy of Dapoxetine in the Treatment of Premature Ejaculation: A Double-Blind, Placebo-Controlled, Fixed-Dose, Randomized Study". Neuropsychopharmacology 33: 1259. doi:. PMID 17625501.
- ^ http://emedicinelive.com/index.php/Sexual-Health/dapoxetine-a-new-drug-for-premature-ejaculation.html
- ^ Symonds T, Perelman MA, Althof S, Giuliano F, Martin M, May K, Abraham L, Crossland A, Morris M (2007). "Development and validation of a premature ejaculation diagnostic tool". Eur Urol. 52: (2): 565–73. PMID 17275165.
- ^ Althof S, Rosen R, Symonds T, Mundayat R, May K, Abraham L (2006). "Development and validation of a new questionnaire to assess sexual satisfaction, control, and distress associated with premature ejaculation.". J Sex Med 3 (3): 465–75. PMID 16681472.
- ^ News – Johnson & Johnson
[edit] External links
- "Premature Ejaculation Drug Promising"
- "The many mysteries of the female orgasm" - An editorial about advances in sexual pharmacology
- "Sexual Health Portal" - PE Disease Awareness Site for Patients, from J&J
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
