A KV Pharmaceutical e-Pharm/alert e-mail for its bacterial vaginosis treatment Clindesse (clindamycin phosphate 2%) vaginal cream overstates claims regarding its efficacy, FDA says in a notice of violation to the company.

The notice, dated May 17 and posted on the agency's Division of Drug Marketing, Advertising and Communications Web site May 22, cites several claims made in a six-page email alert announcing "Clindesse at UnitedHealthcare On formulary Tier 2 co-pay."

The first page of the alert features the statements "Clindesse delivers 88% efficacy and one-dose convenience" and "88% clinical cure rate."

"The claims overstate the efficacy of Clindesse because they are inconsistent with the efficacy information provided in the Clindesse" label and "misrepresent the definition of clinical cure" for BV, FDA says.

In fact, the clinical studies included in the labeling reported clinical cure rates that ranged from 41 percent to 64.3 percent.

The alert also claims that "Clindamycin has demonstrated better activity than metronidazole against three of the most common pathogens implicated in BV," Gardnerella vaginalis, mobiluncus spp and Mycoplasma hominis.

"This claim is misleading because it suggests that Clindesse, as a formulation of clindamycin, is more effective than any metronidazole formulation because of clindamycin's purported superior activity against the most common pathogens in BV," the notice states.

"The references cited do not provide substantial evidence to support any claims of superior in vitro activity or superior clinical effectiveness of clindamycin or Clindesse over metronidazole."

In addition, the claim is misleading because there "is no standard methodology for determining antibiotic susceptibility to Gardnerella vaginalis, mobiluncus spp and Mycoplasma hominis."

DDMAC is requesting that KV halt distribution of the alert and provide a written response on or before June 1 describing the actions the company is taking to comply with the agency's request.

- Brooke McManus (b.mcmanus@elsevier.com)

KV Pharmaceutical's Clindesse Cited For Overstating Efficacy Claims By DDMAC

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