FDA Guidance Addresses Developing Gonorrhea Treatments

August 21, 2015

The primary efficacy endpoint in clinical trials for uncomplicated gonorrhea should be a negative culture at the infection site three to seven days after receiving antibacterial drug therapy, the FDA says.

Secondary endpoints should include the results of a nucleic acid amplification test following treatment and symptom resolution, according to final guidance on developing drugs to treat gonorrhea.

The guidance, released last week, calls for two randomized, double-blind trials of patients who display evidence of uncomplicated gonorrhea, such as infection of the urethra, cervix, pharynx or rectum. Patients who have received effective antibacterial therapy should be excluded and trials should include patients of both sexes and all races.

Sponsors should collect patients’ demographic information, physical exam findings and a microbiological specimen, perform safety laboratory tests and administer the investigational treatment. Three to seven days later, a follow-up treatment should assess microbiological cure using a specimen from the infected site. The FDA encourages single dose treatments for uncomplicated gonorrhea.

The active comparator in a Phase 3 trial should be an antibacterial drug recommended to treat gonorrhea, the guidance says.

To prove safety, the FDA recommends a preapproval database of about 500 patients. Drugs that have the potential to treat both gonorrhea and chlamydia may have concurrent clinical development programs, but sponsors need to discuss Phase 3 plans with the agency.

To view the guidance, go to www.fdanews.com/08-18-15-GonorrheaDrugs.pdf. — Kellen Owings