CTC BIO scores approval for premature ejaculation, erectile dysfunction combo drug

CTC BIO said its new combination drug for the treatment of premature ejaculation and erectile dysfunction, CDFR0812-15/50mg, received approval from the Ministry of Food and Drug Safety (MFDS) on Friday.

According to the company, the combo treatment is "the first in the world" to mix clomipramine HCL, commonly used to treat premature ejaculation, with sildenafil citrate, the active ingredient in Viagra used for erectile dysfunction.

Following the completion of domestic a phase 3 trial, CTC BIO had submitted an application for product approval to the MFDS in June of last year.

Clinical trial results demonstrated that CTC BIO’s combo drug significantly increased the intravaginal ejaculatory latency time (IELT) compared to the monotherapy groups (clomipramine HCL and sildenafil).

The safety profile of the combination drug was found to be comparable to that of the individual therapies.

With the approval, CTC BIO aims to provide a new therapeutic option for patients whose premature ejaculation is inadequately managed by clomipramine monotherapy, thereby expanding treatment opportunities.

“To ensure the rapid market entry of our premature ejaculation treatment combination drug, we have established a business partnership with Dongkook Pharmaceutical, a leader in the urology market,” the company said. “We are completing the final steps of trial production and preparing for product launch.”

Post-marketing surveillance (PMS) will be utilized to capitalize on market penetration while seeking approval in regions that recognize domestic clinical data, he added.

The spokesperson stressed that for markets like Europe and the U.S., the company plans to conduct additional trials to account for inter-ethnic variability before seeking approval.”

Premature ejaculation and erectile dysfunction are two of the most common sexual dysfunctions.

According to the International Society of Andrology, approximately 50 percent of patients with erectile dysfunction also experience symptoms of premature ejaculation.

The combined market for these treatments is estimated to be worth around 200 billion won ($147.6 million) in Korea and over 6 trillion won globally.