The US Food and Drug Administration is set to convene an advisory committee meeting within the next few months to assess the risk of suicide amongst adults using selective serotonin reuptake inhibitors.
According to the FDAadvisorycommittee.com website, Johnson & Johnson’s senior vice president and therapeutic area head of internal medicine, Joanne Waldstreicher, revealed the news during the company’s R&D day in New York. J&J filed its SSRI, dapoxetine, with the FDA back in December for the treatment of premature ejaculation indication. Data released last week showed that dapoxetine tripled the duration of intercourse in men who had been with the same partner for at least six months and persistently suffered from PE [[25/05/05c]].
The SSRI class of drugs, which includes GlaxoSmithKline’s Paxil/Seroxat (paroxetin) and Pfizer’s Zoloft (sertraline) already carry a “black box” warning highlighting an increased risk of suicidal behaviour amongst children and adolescents [[18/10/04b]].
Dapoxetine’s label would presumably have to include the same black box warning, but J&J is keen to differentiate the drug from the rest of the class. “[Dapoxetine] has a different pharmacokinetic profile. [It] has a fast onset of action, peaks at a little more than an hour and is rapidly cleared. This makes the drug ideal for as-needed dosing rather than needing to take it on a daily basis,” Ms Waldstreicher is quoted as saying. “This is unlike the long-acting SSRIs, which are already on the market for other conditions like depression, where the drug hangs around for a long period of time and accumulates,” she added.