Fexapotide triflutate by transrectal injection safely provides long-term relief of symptoms of benign prostatic hyperplasia (BPH), according to results from four related studies.

"Fexapotide will hopefully become another option for urologists and patients discussing choices concerning BPH treatment options,” Dr. Neal Shore from Carolina Urologic Research Center, Myrtle Beach, South Carolina, told Reuters Health by email.

By stimulating a variety of molecular pathways, fexapotide selectively causes loss of prostate glandular epithelial cell integrity, with subsequent decompression of the urethral lumen.

Dr. Shore et al. investigated the safety and efficacy of a single injection of fexapotide triflutate in two long-term follow-up, prospective, double-blind, randomized, placebo-controlled trials and two crossover studies. The studies involved 995 patients at 72 U.S. sites and were conducted from 2009 to 2017.

Fexapotide treatment was associated with significantly greater improvement in BPH Symptom Score at 365 days or last follow-up (median, 5.2 points vs. 3.0 points with placebo), according to the single January 29 World Journal of Urology online report on the four studies.

Adverse event data and laboratory results were similar with treatment versus placebo, and there were no fexapotide-related sexual side effects.

The incidence of spontaneous acute urinary retention within 3 years was significantly lower with fexapotide (1.08%) than with placebo (5.63%), as was the incidence of newly diagnosed prostate cancer at 4 years (1.1% vs. 5.3%).

In the crossover studies, the 3-year incidence of BPH surgery was far lower among men who received fexapotide (8.08%) than among those treated with other BPH medications (27.85%).

“Fexapotide has a very well-tolerated adverse event profile and appears to be very safe and easily administered in the clinic without a need for any systemic anesthesia,” Dr. Shore said.

“The relatively painless transrectal ultrasound-guided injection is an office procedure with no catheter requirement and requires approximately 5 minutes to complete.”

Many men are not happy with taking daily oral medications, and others will cease using these medications due to compliance or side effects,” he said.

“When this occurs, most men are then only left with a variation of a cystoscopic intervention designed to unobstruct the prostatic tissue. Fexapotide should hopefully help this very large population of men who face this dilemma.”

Nymox Pharmaceutical Corporation, which makes fexapotide triflutate, funded the studies and had various relationships with 4 of the 17 authors of this report, including Dr. Shore.