Dapoxetine
- Generic Name
- Dapoxetine
- Drug Type
- Small Molecule
- Chemical Formula
- C21H23NO
- CAS Number
- 119356-77-3
- Unique Ingredient Identifier
- GB2433A4M3
Overview
Dapoxetine is a selective serotonin reuptake inhibitor, for the treatment of premature ejaculation. In a phase II proof-of-concept study conducted by PPD, dapoxetine demonstrated a statistically significant increase in ejaculatory latency when compared to placebo. Alza submitted a NDA to the FDA for dapoxetine for the treatment of premature ejaculation in December 2004. In October 2005, the company received a FDA Non-Approvable letter from the FDA, at which time they planned to work with regulators to address outstanding questions.
Background
Dapoxetine is a selective serotonin reuptake inhibitor, for the treatment of premature ejaculation. In a phase II proof-of-concept study conducted by PPD, dapoxetine demonstrated a statistically significant increase in ejaculatory latency when compared to placebo. Alza submitted a NDA to the FDA for dapoxetine for the treatment of premature ejaculation in December 2004. In October 2005, the company received a FDA Non-Approvable letter from the FDA, at which time they planned to work with regulators to address outstanding questions.
Indication
For the treatment of premature ejaculation.
Associated Conditions
- Premature Ejaculation
Clinical Trials
FDA Approved Products
Singapore Approved Products
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